Trial Outcomes & Findings for Study of Evinacumab (REGN1500) in Participants With Persistent Hypercholesterolemia (NCT NCT03175367)
NCT ID: NCT03175367
Last Updated: 2023-02-10
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
272 participants
Primary outcome timeframe
Baseline and Week 16
Results posted on
2023-02-10
Participant Flow
A total of 327 participants were screened and 272 participants randomized. Six participants were randomized but never treated.
Participant milestones
| Measure |
Group A: Placebo SC QW (DBTP)
Placebo subcutaneous (SC) treatment every week (QW) for 16 weeks during the double-blind treatment period (DBTP) followed by a 23-week follow-up period
|
Group A: Evinacumab 300 mg SC Q2W (DBTP)
Evinacumab 300 mg SC treatment every other week (Q2W) (alternating with placebo on opposite weeks) for 16 weeks during the DBTP followed by a 23-week follow-up period
|
Group A: Evinacumab 300 mg SC QW (DBTP)
Evinacumab 300 mg SC treatment QW for 16 weeks during the DBTP followed by a 23-week follow-up period
|
Group A: Evinacumab 450 mg SC QW (DBTP)
Evinacumab 450 mg SC treatment QW for 16 weeks during the DBTP followed by a 23-week follow-up period
|
Group B: Placebo IV Q4W (DBTP to OLTP)
Placebo intravenous (IV) treatment every 4 weeks (Q4W) during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week open-label treatment period (OLTP) regardless of treatment assignment in the DBTP
|
Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP)
Evinacumab 5 mg/kg IV treatment Q4W during the 24-week DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP
|
Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP)
Evinacumab 15 mg/kg IV treatment Q4W during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP
|
|---|---|---|---|---|---|---|---|
|
Double-blind Treatment Period (DBTP)
STARTED
|
39
|
39
|
42
|
40
|
33
|
35
|
38
|
|
Double-blind Treatment Period (DBTP)
COMPLETED
|
30
|
31
|
30
|
30
|
31
|
32
|
34
|
|
Double-blind Treatment Period (DBTP)
NOT COMPLETED
|
9
|
8
|
12
|
10
|
2
|
3
|
4
|
|
Open-Label Treatment Period (OLTP)
STARTED
|
0
|
0
|
0
|
0
|
31
|
32
|
33
|
|
Open-Label Treatment Period (OLTP)
COMPLETED
|
0
|
0
|
0
|
0
|
31
|
30
|
31
|
|
Open-Label Treatment Period (OLTP)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
2
|
2
|
Reasons for withdrawal
| Measure |
Group A: Placebo SC QW (DBTP)
Placebo subcutaneous (SC) treatment every week (QW) for 16 weeks during the double-blind treatment period (DBTP) followed by a 23-week follow-up period
|
Group A: Evinacumab 300 mg SC Q2W (DBTP)
Evinacumab 300 mg SC treatment every other week (Q2W) (alternating with placebo on opposite weeks) for 16 weeks during the DBTP followed by a 23-week follow-up period
|
Group A: Evinacumab 300 mg SC QW (DBTP)
Evinacumab 300 mg SC treatment QW for 16 weeks during the DBTP followed by a 23-week follow-up period
|
Group A: Evinacumab 450 mg SC QW (DBTP)
Evinacumab 450 mg SC treatment QW for 16 weeks during the DBTP followed by a 23-week follow-up period
|
Group B: Placebo IV Q4W (DBTP to OLTP)
Placebo intravenous (IV) treatment every 4 weeks (Q4W) during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week open-label treatment period (OLTP) regardless of treatment assignment in the DBTP
|
Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP)
Evinacumab 5 mg/kg IV treatment Q4W during the 24-week DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP
|
Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP)
Evinacumab 15 mg/kg IV treatment Q4W during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP
|
|---|---|---|---|---|---|---|---|
|
Double-blind Treatment Period (DBTP)
Protocol Violation
|
0
|
0
|
1
|
2
|
0
|
0
|
2
|
|
Double-blind Treatment Period (DBTP)
Adverse Event
|
2
|
2
|
0
|
0
|
1
|
2
|
2
|
|
Double-blind Treatment Period (DBTP)
Withdrawal by Subject
|
1
|
1
|
2
|
2
|
0
|
1
|
0
|
|
Double-blind Treatment Period (DBTP)
Physician Decision
|
6
|
5
|
8
|
6
|
0
|
0
|
0
|
|
Double-blind Treatment Period (DBTP)
Lost to Follow-up
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
|
Open-Label Treatment Period (OLTP)
Noncompliance with protocol
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Open-Label Treatment Period (OLTP)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
2
|
1
|
Baseline Characteristics
Study of Evinacumab (REGN1500) in Participants With Persistent Hypercholesterolemia
Baseline characteristics by cohort
| Measure |
Group A: Placebo SC QW (DBTP)
n=39 Participants
Placebo subcutaneous (SC) treatment every week (QW) for 16 weeks during the double-blind treatment period (DBTP) followed by a 23-week follow-up period
|
Group A: Evinacumab 300 mg SC Q2W (DBTP)
n=39 Participants
Evinacumab 300 mg SC treatment every other week (Q2W) (alternating with placebo on opposite weeks) for 16 weeks during the DBTP followed by a 23-week follow-up period
|
Group A: Evinacumab 300 mg SC QW (DBTP)
n=42 Participants
Evinacumab 300 mg SC treatment QW for 16 weeks during the DBTP followed by a 23-week follow-up period
|
Group A: Evinacumab 450 mg SC QW (DBTP)
n=40 Participants
Evinacumab 450 mg SC treatment QW for 16 weeks during the DBTP followed by a 23-week follow-up period
|
Group B: Placebo IV Q4W (DBTP to OLTP)
n=33 Participants
Placebo intravenous (IV) treatment every 4 weeks (Q4W) during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week open-label treatment period (OLTP) regardless of treatment assignment in the DBTP
|
Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP)
n=35 Participants
Evinacumab 5 mg/kg IV treatment Q4W during the 24-week DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP
|
Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP)
n=38 Participants
Evinacumab 15 mg/kg IV treatment Q4W during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP
|
Total
n=266 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Customized
Adults (18-64 years)
|
34 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
28 Participants
n=8 Participants
|
33 Participants
n=8 Participants
|
214 Participants
n=24 Participants
|
|
Age, Customized
From 65-84 years
|
5 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
52 Participants
n=24 Participants
|
|
Age, Customized
85 years and over
|
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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
22 Participants
n=8 Participants
|
19 Participants
n=8 Participants
|
159 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
13 Participants
n=8 Participants
|
19 Participants
n=8 Participants
|
107 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
23 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
28 Participants
n=8 Participants
|
36 Participants
n=8 Participants
|
237 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska 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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
32 Participants
n=8 Participants
|
35 Participants
n=8 Participants
|
239 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
16 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 16Outcome measures
| Measure |
Group A: Placebo SC QW (DBTP)
n=39 Participants
Placebo subcutaneous (SC) treatment every week (QW) for 16 weeks during the double-blind treatment period (DBTP) followed by a 23-week follow-up period
|
Group A: Evinacumab 300 mg SC Q2W (DBTP)
n=39 Participants
Evinacumab 300 mg SC treatment every other week (Q2W) (alternating with placebo on opposite weeks) for 16 weeks during the DBTP followed by a 23-week follow-up period
|
Group A: Evinacumab 300 mg SC QW (DBTP)
n=42 Participants
Evinacumab 300 mg SC treatment QW for 16 weeks during the DBTP followed by a 23-week follow-up period
|
Group A: Evinacumab 450 mg SC QW (DBTP)
n=40 Participants
Evinacumab 450 mg SC treatment QW for 16 weeks during the DBTP followed by a 23-week follow-up period
|
Group B: Placebo IV Q4W (DBTP to OLTP)
n=33 Participants
Placebo intravenous (IV) treatment every 4 weeks (Q4W) during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week open-label treatment period (OLTP) regardless of treatment assignment in the DBTP
|
Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP)
n=35 Participants
Evinacumab 5 mg/kg IV treatment Q4W during the 24-week DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP
|
Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP)
n=38 Participants
Evinacumab 15 mg/kg IV treatment Q4W during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol (LDL-C) at Week 16 (Intent-to-Treat [ITT] Estimand)
|
8.8 Percent Change
Standard Error 6.4 • Interval 6.4 to
|
-29.7 Percent Change
Standard Error 6.4 • Interval 6.4 to
|
-44.0 Percent Change
Standard Error 6.3 • Interval 6.3 to
|
-47.2 Percent Change
Standard Error 6.2 • Interval 6.2 to
|
0.6 Percent Change
Standard Error 6.6 • Interval 6.6 to
|
-23.5 Percent Change
Standard Error 6.6 • Interval 6.6 to
|
-49.9 Percent Change
Standard Error 6.1 • Interval 6.1 to
|
SECONDARY outcome
Timeframe: Baseline and Week 16Outcome measures
| Measure |
Group A: Placebo SC QW (DBTP)
n=39 Participants
Placebo subcutaneous (SC) treatment every week (QW) for 16 weeks during the double-blind treatment period (DBTP) followed by a 23-week follow-up period
|
Group A: Evinacumab 300 mg SC Q2W (DBTP)
n=39 Participants
Evinacumab 300 mg SC treatment every other week (Q2W) (alternating with placebo on opposite weeks) for 16 weeks during the DBTP followed by a 23-week follow-up period
|
Group A: Evinacumab 300 mg SC QW (DBTP)
n=42 Participants
Evinacumab 300 mg SC treatment QW for 16 weeks during the DBTP followed by a 23-week follow-up period
|
Group A: Evinacumab 450 mg SC QW (DBTP)
n=40 Participants
Evinacumab 450 mg SC treatment QW for 16 weeks during the DBTP followed by a 23-week follow-up period
|
Group B: Placebo IV Q4W (DBTP to OLTP)
n=33 Participants
Placebo intravenous (IV) treatment every 4 weeks (Q4W) during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week open-label treatment period (OLTP) regardless of treatment assignment in the DBTP
|
Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP)
n=35 Participants
Evinacumab 5 mg/kg IV treatment Q4W during the 24-week DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP
|
Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP)
n=38 Participants
Evinacumab 15 mg/kg IV treatment Q4W during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 16 (ITT Estimand)
|
6.7 Percent Change
Standard Error 5.1 • Interval 5.1 to
|
-19.9 Percent Change
Standard Error 5.1 • Interval 5.1 to
|
-35.2 Percent Change
Standard Error 5.1 • Interval 5.1 to
|
-38.8 Percent Change
Standard Error 4.9 • Interval 4.9 to
|
-3.8 Percent Change
Standard Error 4.7 • Interval 4.7 to
|
-20.4 Percent Change
Standard Error 4.6 • Interval 4.6 to
|
-43.2 Percent Change
Standard Error 4.3 • Interval 4.3 to
|
SECONDARY outcome
Timeframe: Baseline and Week 24Outcome measures
| Measure |
Group A: Placebo SC QW (DBTP)
n=33 Participants
Placebo subcutaneous (SC) treatment every week (QW) for 16 weeks during the double-blind treatment period (DBTP) followed by a 23-week follow-up period
|
Group A: Evinacumab 300 mg SC Q2W (DBTP)
n=35 Participants
Evinacumab 300 mg SC treatment every other week (Q2W) (alternating with placebo on opposite weeks) for 16 weeks during the DBTP followed by a 23-week follow-up period
|
Group A: Evinacumab 300 mg SC QW (DBTP)
n=38 Participants
Evinacumab 300 mg SC treatment QW for 16 weeks during the DBTP followed by a 23-week follow-up period
|
Group A: Evinacumab 450 mg SC QW (DBTP)
Evinacumab 450 mg SC treatment QW for 16 weeks during the DBTP followed by a 23-week follow-up period
|
Group B: Placebo IV Q4W (DBTP to OLTP)
Placebo intravenous (IV) treatment every 4 weeks (Q4W) during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week open-label treatment period (OLTP) regardless of treatment assignment in the DBTP
|
Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP)
Evinacumab 5 mg/kg IV treatment Q4W during the 24-week DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP
|
Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP)
Evinacumab 15 mg/kg IV treatment Q4W during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Apo B at Week 24 (ITT Estimand)
|
5.9 Percent Change
Standard Error 6.0 • Interval 6.0 to
|
-15.9 Percent Change
Standard Error 5.9 • Interval 5.9 to
|
-34.5 Percent Change
Standard Error 5.6 • Interval 5.6 to
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 16Outcome measures
| Measure |
Group A: Placebo SC QW (DBTP)
n=39 Participants
Placebo subcutaneous (SC) treatment every week (QW) for 16 weeks during the double-blind treatment period (DBTP) followed by a 23-week follow-up period
|
Group A: Evinacumab 300 mg SC Q2W (DBTP)
n=39 Participants
Evinacumab 300 mg SC treatment every other week (Q2W) (alternating with placebo on opposite weeks) for 16 weeks during the DBTP followed by a 23-week follow-up period
|
Group A: Evinacumab 300 mg SC QW (DBTP)
n=42 Participants
Evinacumab 300 mg SC treatment QW for 16 weeks during the DBTP followed by a 23-week follow-up period
|
Group A: Evinacumab 450 mg SC QW (DBTP)
n=40 Participants
Evinacumab 450 mg SC treatment QW for 16 weeks during the DBTP followed by a 23-week follow-up period
|
Group B: Placebo IV Q4W (DBTP to OLTP)
n=33 Participants
Placebo intravenous (IV) treatment every 4 weeks (Q4W) during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week open-label treatment period (OLTP) regardless of treatment assignment in the DBTP
|
Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP)
n=35 Participants
Evinacumab 5 mg/kg IV treatment Q4W during the 24-week DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP
|
Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP)
n=38 Participants
Evinacumab 15 mg/kg IV treatment Q4W during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 16 (ITT Estimand)
|
8.0 Percent Change
Standard Error 5.4 • Interval 5.4 to
|
-31.3 Percent Change
Standard Error 5.4 • Interval 5.4 to
|
-45.8 Percent Change
Standard Error 5.3 • Interval 5.3 to
|
-50.6 Percent Change
Standard Error 5.2 • Interval 5.2 to
|
-1.1 Percent Change
Standard Error 5.8 • Interval 5.8 to
|
-24.8 Percent Change
Standard Error 5.7 • Interval 5.7 to
|
-52.0 Percent Change
Standard Error 5.3 • Interval 5.3 to
|
SECONDARY outcome
Timeframe: Baseline and Week 24Outcome measures
| Measure |
Group A: Placebo SC QW (DBTP)
n=33 Participants
Placebo subcutaneous (SC) treatment every week (QW) for 16 weeks during the double-blind treatment period (DBTP) followed by a 23-week follow-up period
|
Group A: Evinacumab 300 mg SC Q2W (DBTP)
n=35 Participants
Evinacumab 300 mg SC treatment every other week (Q2W) (alternating with placebo on opposite weeks) for 16 weeks during the DBTP followed by a 23-week follow-up period
|
Group A: Evinacumab 300 mg SC QW (DBTP)
n=38 Participants
Evinacumab 300 mg SC treatment QW for 16 weeks during the DBTP followed by a 23-week follow-up period
|
Group A: Evinacumab 450 mg SC QW (DBTP)
Evinacumab 450 mg SC treatment QW for 16 weeks during the DBTP followed by a 23-week follow-up period
|
Group B: Placebo IV Q4W (DBTP to OLTP)
Placebo intravenous (IV) treatment every 4 weeks (Q4W) during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week open-label treatment period (OLTP) regardless of treatment assignment in the DBTP
|
Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP)
Evinacumab 5 mg/kg IV treatment Q4W during the 24-week DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP
|
Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP)
Evinacumab 15 mg/kg IV treatment Q4W during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Non-HDL-C at Week 24 (ITT Estimand)
|
10.4 Percent Change
Standard Error 7.0 • Interval 7.0 to
|
-20.2 Percent Change
Standard Error 6.7 • Interval 6.7 to
|
-44.3 Percent Change
Standard Error 6.4 • Interval 6.4 to
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 16Outcome measures
| Measure |
Group A: Placebo SC QW (DBTP)
n=39 Participants
Placebo subcutaneous (SC) treatment every week (QW) for 16 weeks during the double-blind treatment period (DBTP) followed by a 23-week follow-up period
|
Group A: Evinacumab 300 mg SC Q2W (DBTP)
n=39 Participants
Evinacumab 300 mg SC treatment every other week (Q2W) (alternating with placebo on opposite weeks) for 16 weeks during the DBTP followed by a 23-week follow-up period
|
Group A: Evinacumab 300 mg SC QW (DBTP)
n=42 Participants
Evinacumab 300 mg SC treatment QW for 16 weeks during the DBTP followed by a 23-week follow-up period
|
Group A: Evinacumab 450 mg SC QW (DBTP)
n=40 Participants
Evinacumab 450 mg SC treatment QW for 16 weeks during the DBTP followed by a 23-week follow-up period
|
Group B: Placebo IV Q4W (DBTP to OLTP)
n=33 Participants
Placebo intravenous (IV) treatment every 4 weeks (Q4W) during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week open-label treatment period (OLTP) regardless of treatment assignment in the DBTP
|
Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP)
n=35 Participants
Evinacumab 5 mg/kg IV treatment Q4W during the 24-week DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP
|
Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP)
n=38 Participants
Evinacumab 15 mg/kg IV treatment Q4W during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With >= 30% Reduction in Calculated LDL-C at Week 16 (ITT Estimand)
|
11.3 Percentage of Participants
|
68.1 Percentage of Participants
|
73.9 Percentage of Participants
|
71.4 Percentage of Participants
|
15.5 Percentage of Participants
|
57.9 Percentage of Participants
|
86.8 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 16Outcome measures
| Measure |
Group A: Placebo SC QW (DBTP)
n=39 Participants
Placebo subcutaneous (SC) treatment every week (QW) for 16 weeks during the double-blind treatment period (DBTP) followed by a 23-week follow-up period
|
Group A: Evinacumab 300 mg SC Q2W (DBTP)
n=39 Participants
Evinacumab 300 mg SC treatment every other week (Q2W) (alternating with placebo on opposite weeks) for 16 weeks during the DBTP followed by a 23-week follow-up period
|
Group A: Evinacumab 300 mg SC QW (DBTP)
n=42 Participants
Evinacumab 300 mg SC treatment QW for 16 weeks during the DBTP followed by a 23-week follow-up period
|
Group A: Evinacumab 450 mg SC QW (DBTP)
n=40 Participants
Evinacumab 450 mg SC treatment QW for 16 weeks during the DBTP followed by a 23-week follow-up period
|
Group B: Placebo IV Q4W (DBTP to OLTP)
n=33 Participants
Placebo intravenous (IV) treatment every 4 weeks (Q4W) during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week open-label treatment period (OLTP) regardless of treatment assignment in the DBTP
|
Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP)
n=35 Participants
Evinacumab 5 mg/kg IV treatment Q4W during the 24-week DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP
|
Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP)
n=38 Participants
Evinacumab 15 mg/kg IV treatment Q4W during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With >= 50% Reduction in Calculated LDL-C at Week 16 (ITT Estimand)
|
5.2 Percentage of Participants
|
28.6 Percentage of Participants
|
53.7 Percentage of Participants
|
60.6 Percentage of Participants
|
12.3 Percentage of Participants
|
24.6 Percentage of Participants
|
63.2 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 16Percentage of Participants with Calculated LDL-C \< 50 milligrams/deciliter (mg/dL) \[1.30 Millimoles per liter (mmol/L)\] at Week 16 (ITT Estimand)
Outcome measures
| Measure |
Group A: Placebo SC QW (DBTP)
n=39 Participants
Placebo subcutaneous (SC) treatment every week (QW) for 16 weeks during the double-blind treatment period (DBTP) followed by a 23-week follow-up period
|
Group A: Evinacumab 300 mg SC Q2W (DBTP)
n=39 Participants
Evinacumab 300 mg SC treatment every other week (Q2W) (alternating with placebo on opposite weeks) for 16 weeks during the DBTP followed by a 23-week follow-up period
|
Group A: Evinacumab 300 mg SC QW (DBTP)
n=42 Participants
Evinacumab 300 mg SC treatment QW for 16 weeks during the DBTP followed by a 23-week follow-up period
|
Group A: Evinacumab 450 mg SC QW (DBTP)
n=40 Participants
Evinacumab 450 mg SC treatment QW for 16 weeks during the DBTP followed by a 23-week follow-up period
|
Group B: Placebo IV Q4W (DBTP to OLTP)
n=33 Participants
Placebo intravenous (IV) treatment every 4 weeks (Q4W) during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week open-label treatment period (OLTP) regardless of treatment assignment in the DBTP
|
Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP)
n=35 Participants
Evinacumab 5 mg/kg IV treatment Q4W during the 24-week DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP
|
Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP)
n=38 Participants
Evinacumab 15 mg/kg IV treatment Q4W during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Calculated LDL-C < 50 mg/dL (1.30 mmol/L) at Week 16 (ITT Estimand)
|
5.1 Percentage of Participants
|
22.8 Percentage of Participants
|
29.7 Percentage of Participants
|
40.8 Percentage of Participants
|
9.3 Percentage of Participants
|
13.2 Percentage of Participants
|
39.5 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 24Outcome measures
| Measure |
Group A: Placebo SC QW (DBTP)
n=33 Participants
Placebo subcutaneous (SC) treatment every week (QW) for 16 weeks during the double-blind treatment period (DBTP) followed by a 23-week follow-up period
|
Group A: Evinacumab 300 mg SC Q2W (DBTP)
n=35 Participants
Evinacumab 300 mg SC treatment every other week (Q2W) (alternating with placebo on opposite weeks) for 16 weeks during the DBTP followed by a 23-week follow-up period
|
Group A: Evinacumab 300 mg SC QW (DBTP)
n=38 Participants
Evinacumab 300 mg SC treatment QW for 16 weeks during the DBTP followed by a 23-week follow-up period
|
Group A: Evinacumab 450 mg SC QW (DBTP)
Evinacumab 450 mg SC treatment QW for 16 weeks during the DBTP followed by a 23-week follow-up period
|
Group B: Placebo IV Q4W (DBTP to OLTP)
Placebo intravenous (IV) treatment every 4 weeks (Q4W) during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week open-label treatment period (OLTP) regardless of treatment assignment in the DBTP
|
Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP)
Evinacumab 5 mg/kg IV treatment Q4W during the 24-week DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP
|
Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP)
Evinacumab 15 mg/kg IV treatment Q4W during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Calculated LDL-C at Week 24 (ITT Estimand)
|
14.8 Percent Change
Standard Error 8.3 • Interval 8.3 to
|
-17.7 Percent Change
Standard Error 8.0 • Interval 8.0 to
|
-39.7 Percent Change
Standard Error 7.7 • Interval 7.7 to
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 16Outcome measures
| Measure |
Group A: Placebo SC QW (DBTP)
n=39 Participants
Placebo subcutaneous (SC) treatment every week (QW) for 16 weeks during the double-blind treatment period (DBTP) followed by a 23-week follow-up period
|
Group A: Evinacumab 300 mg SC Q2W (DBTP)
n=39 Participants
Evinacumab 300 mg SC treatment every other week (Q2W) (alternating with placebo on opposite weeks) for 16 weeks during the DBTP followed by a 23-week follow-up period
|
Group A: Evinacumab 300 mg SC QW (DBTP)
n=42 Participants
Evinacumab 300 mg SC treatment QW for 16 weeks during the DBTP followed by a 23-week follow-up period
|
Group A: Evinacumab 450 mg SC QW (DBTP)
n=40 Participants
Evinacumab 450 mg SC treatment QW for 16 weeks during the DBTP followed by a 23-week follow-up period
|
Group B: Placebo IV Q4W (DBTP to OLTP)
n=33 Participants
Placebo intravenous (IV) treatment every 4 weeks (Q4W) during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week open-label treatment period (OLTP) regardless of treatment assignment in the DBTP
|
Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP)
n=35 Participants
Evinacumab 5 mg/kg IV treatment Q4W during the 24-week DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP
|
Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP)
n=38 Participants
Evinacumab 15 mg/kg IV treatment Q4W during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Total Cholesterol (TC) at Week 16 (ITT Estimand)
|
6.1 Percent Change
Standard Error 4.0 • Interval 4.0 to
|
-31.0 Percent Change
Standard Error 4.0 • Interval 4.0 to
|
-40.3 Percent Change
Standard Error 4.0 • Interval 4.0 to
|
-45.4 Percent Change
Standard Error 3.9 • Interval 3.9 to
|
-0.4 Percent Change
Standard Error 4.5 • Interval 4.5 to
|
-22.6 Percent Change
Standard Error 4.4 • Interval 4.4 to
|
-46.8 Percent Change
Standard Error 4.1 • Interval 4.1 to
|
SECONDARY outcome
Timeframe: Baseline and Week 24Outcome measures
| Measure |
Group A: Placebo SC QW (DBTP)
n=33 Participants
Placebo subcutaneous (SC) treatment every week (QW) for 16 weeks during the double-blind treatment period (DBTP) followed by a 23-week follow-up period
|
Group A: Evinacumab 300 mg SC Q2W (DBTP)
n=35 Participants
Evinacumab 300 mg SC treatment every other week (Q2W) (alternating with placebo on opposite weeks) for 16 weeks during the DBTP followed by a 23-week follow-up period
|
Group A: Evinacumab 300 mg SC QW (DBTP)
n=38 Participants
Evinacumab 300 mg SC treatment QW for 16 weeks during the DBTP followed by a 23-week follow-up period
|
Group A: Evinacumab 450 mg SC QW (DBTP)
Evinacumab 450 mg SC treatment QW for 16 weeks during the DBTP followed by a 23-week follow-up period
|
Group B: Placebo IV Q4W (DBTP to OLTP)
Placebo intravenous (IV) treatment every 4 weeks (Q4W) during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week open-label treatment period (OLTP) regardless of treatment assignment in the DBTP
|
Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP)
Evinacumab 5 mg/kg IV treatment Q4W during the 24-week DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP
|
Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP)
Evinacumab 15 mg/kg IV treatment Q4W during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Total Cholesterol at Week 24 (ITT Estimand)
|
8.5 Percent Change
Standard Error 5.1 • Interval 5.1 to
|
-19.9 Percent Change
Standard Error 4.9 • Interval 4.9 to
|
-40.8 Percent Change
Standard Error 4.7 • Interval 4.7 to
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 16Outcome measures
| Measure |
Group A: Placebo SC QW (DBTP)
n=39 Participants
Placebo subcutaneous (SC) treatment every week (QW) for 16 weeks during the double-blind treatment period (DBTP) followed by a 23-week follow-up period
|
Group A: Evinacumab 300 mg SC Q2W (DBTP)
n=39 Participants
Evinacumab 300 mg SC treatment every other week (Q2W) (alternating with placebo on opposite weeks) for 16 weeks during the DBTP followed by a 23-week follow-up period
|
Group A: Evinacumab 300 mg SC QW (DBTP)
n=42 Participants
Evinacumab 300 mg SC treatment QW for 16 weeks during the DBTP followed by a 23-week follow-up period
|
Group A: Evinacumab 450 mg SC QW (DBTP)
n=40 Participants
Evinacumab 450 mg SC treatment QW for 16 weeks during the DBTP followed by a 23-week follow-up period
|
Group B: Placebo IV Q4W (DBTP to OLTP)
n=33 Participants
Placebo intravenous (IV) treatment every 4 weeks (Q4W) during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week open-label treatment period (OLTP) regardless of treatment assignment in the DBTP
|
Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP)
n=35 Participants
Evinacumab 5 mg/kg IV treatment Q4W during the 24-week DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP
|
Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP)
n=38 Participants
Evinacumab 15 mg/kg IV treatment Q4W during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Fasting Triglycerides at Week 16 (ITT Estimand)
|
8.1 Percent Change
Standard Error 4.5 • Interval 4.5 to
|
-38.0 Percent Change
Standard Error 4.2 • Interval 4.2 to
|
-47.7 Percent Change
Standard Error 4.0 • Interval 4.0 to
|
-53.4 Percent Change
Standard Error 3.9 • Interval 3.9 to
|
-6.9 Percent Change
Standard Error 4.7 • Interval 4.7 to
|
-32.1 Percent Change
Standard Error 4.5 • Interval 4.5 to
|
-52.8 Percent Change
Standard Error 4.1 • Interval 4.1 to
|
SECONDARY outcome
Timeframe: Baseline and Week 24Outcome measures
| Measure |
Group A: Placebo SC QW (DBTP)
n=33 Participants
Placebo subcutaneous (SC) treatment every week (QW) for 16 weeks during the double-blind treatment period (DBTP) followed by a 23-week follow-up period
|
Group A: Evinacumab 300 mg SC Q2W (DBTP)
n=35 Participants
Evinacumab 300 mg SC treatment every other week (Q2W) (alternating with placebo on opposite weeks) for 16 weeks during the DBTP followed by a 23-week follow-up period
|
Group A: Evinacumab 300 mg SC QW (DBTP)
n=38 Participants
Evinacumab 300 mg SC treatment QW for 16 weeks during the DBTP followed by a 23-week follow-up period
|
Group A: Evinacumab 450 mg SC QW (DBTP)
Evinacumab 450 mg SC treatment QW for 16 weeks during the DBTP followed by a 23-week follow-up period
|
Group B: Placebo IV Q4W (DBTP to OLTP)
Placebo intravenous (IV) treatment every 4 weeks (Q4W) during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week open-label treatment period (OLTP) regardless of treatment assignment in the DBTP
|
Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP)
Evinacumab 5 mg/kg IV treatment Q4W during the 24-week DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP
|
Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP)
Evinacumab 15 mg/kg IV treatment Q4W during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Fasting Triglycerides at Week 24 (ITT Estimand)
|
-6.1 Percent Change
Standard Error 5.4 • Interval 5.4 to
|
-23.2 Percent Change
Standard Error 5.1 • Interval 5.1 to
|
-51.3 Percent Change
Standard Error 4.8 • Interval 4.8 to
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 16Outcome measures
| Measure |
Group A: Placebo SC QW (DBTP)
n=39 Participants
Placebo subcutaneous (SC) treatment every week (QW) for 16 weeks during the double-blind treatment period (DBTP) followed by a 23-week follow-up period
|
Group A: Evinacumab 300 mg SC Q2W (DBTP)
n=39 Participants
Evinacumab 300 mg SC treatment every other week (Q2W) (alternating with placebo on opposite weeks) for 16 weeks during the DBTP followed by a 23-week follow-up period
|
Group A: Evinacumab 300 mg SC QW (DBTP)
n=42 Participants
Evinacumab 300 mg SC treatment QW for 16 weeks during the DBTP followed by a 23-week follow-up period
|
Group A: Evinacumab 450 mg SC QW (DBTP)
n=40 Participants
Evinacumab 450 mg SC treatment QW for 16 weeks during the DBTP followed by a 23-week follow-up period
|
Group B: Placebo IV Q4W (DBTP to OLTP)
n=33 Participants
Placebo intravenous (IV) treatment every 4 weeks (Q4W) during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week open-label treatment period (OLTP) regardless of treatment assignment in the DBTP
|
Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP)
n=35 Participants
Evinacumab 5 mg/kg IV treatment Q4W during the 24-week DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP
|
Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP)
n=38 Participants
Evinacumab 15 mg/kg IV treatment Q4W during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Lipoprotein a [Lp(a)] at Week 16 (ITT Estimand)
|
0.3 Percent Change
Standard Error 3.9 • Interval 3.9 to
|
-10.3 Percent Change
Standard Error 4.1 • Interval 4.1 to
|
-11.6 Percent Change
Standard Error 4.0 • Interval 4.0 to
|
-8.9 Percent Change
Standard Error 4.0 • Interval 4.0 to
|
0.8 Percent Change
Standard Error 3.7 • Interval 3.7 to
|
-15.7 Percent Change
Standard Error 3.7 • Interval 3.7 to
|
-15.7 Percent Change
Standard Error 3.3 • Interval 3.3 to
|
SECONDARY outcome
Timeframe: Baseline and Week 24Outcome measures
| Measure |
Group A: Placebo SC QW (DBTP)
n=33 Participants
Placebo subcutaneous (SC) treatment every week (QW) for 16 weeks during the double-blind treatment period (DBTP) followed by a 23-week follow-up period
|
Group A: Evinacumab 300 mg SC Q2W (DBTP)
n=35 Participants
Evinacumab 300 mg SC treatment every other week (Q2W) (alternating with placebo on opposite weeks) for 16 weeks during the DBTP followed by a 23-week follow-up period
|
Group A: Evinacumab 300 mg SC QW (DBTP)
n=38 Participants
Evinacumab 300 mg SC treatment QW for 16 weeks during the DBTP followed by a 23-week follow-up period
|
Group A: Evinacumab 450 mg SC QW (DBTP)
Evinacumab 450 mg SC treatment QW for 16 weeks during the DBTP followed by a 23-week follow-up period
|
Group B: Placebo IV Q4W (DBTP to OLTP)
Placebo intravenous (IV) treatment every 4 weeks (Q4W) during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week open-label treatment period (OLTP) regardless of treatment assignment in the DBTP
|
Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP)
Evinacumab 5 mg/kg IV treatment Q4W during the 24-week DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP
|
Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP)
Evinacumab 15 mg/kg IV treatment Q4W during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Lipoprotein (a) [Lp(a)] at Week 24 (ITT Estimand)
|
-1.4 Percent Change
Standard Error 4.1 • Interval 4.1 to
|
-17.5 Percent Change
Standard Error 4.0 • Interval 4.0 to
|
-16.0 Percent Change
Standard Error 3.7 • Interval 3.7 to
|
—
|
—
|
—
|
—
|
Adverse Events
Group B: Placebo IV Q4W (OLTP)
Serious events: 4 serious events
Other events: 19 other events
Deaths: 0 deaths
Group A: Placebo SC QW (DBTP)
Serious events: 3 serious events
Other events: 20 other events
Deaths: 0 deaths
Group A: Evinacumab 300 mg SC Q2W (DBTP)
Serious events: 2 serious events
Other events: 27 other events
Deaths: 1 deaths
Group A: Evinacumab 300 mg SC QW (DBTP)
Serious events: 4 serious events
Other events: 26 other events
Deaths: 1 deaths
Group A: Evinacumab 450 mg SC QW (DBTP)
Serious events: 4 serious events
Other events: 22 other events
Deaths: 0 deaths
Group B: Placebo IV Q4W (DBTP)
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)
Serious events: 2 serious events
Other events: 23 other events
Deaths: 0 deaths
Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)
Serious events: 6 serious events
Other events: 24 other events
Deaths: 0 deaths
Group B: Evinacumab 5 mg/kg IV Q4W (OLTP)
Serious events: 3 serious events
Other events: 22 other events
Deaths: 0 deaths
Group B: Evinacumab 15 mg/kg IV Q4W (OLTP)
Serious events: 2 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group B: Placebo IV Q4W (OLTP)
n=31 participants at risk
Placebo intravenous (IV) treatment every 4 weeks (Q4W) during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week open-label treatment period (OLTP) regardless of treatment assignment in the DBTP
|
Group A: Placebo SC QW (DBTP)
n=39 participants at risk
Placebo subcutaneous (SC) treatment every week (QW) for 16 weeks during the double-blind treatment period (DBTP) followed by a 23-week follow-up period
|
Group A: Evinacumab 300 mg SC Q2W (DBTP)
n=39 participants at risk
Evinacumab 300 mg SC treatment every other week (Q2W) (alternating with placebo on opposite weeks) for 16 weeks during the DBTP followed by a 23-week follow-up period
|
Group A: Evinacumab 300 mg SC QW (DBTP)
n=42 participants at risk
Evinacumab 300 mg SC treatment QW for 16 weeks during the DBTP followed by a 23-week follow-up period
|
Group A: Evinacumab 450 mg SC QW (DBTP)
n=40 participants at risk
Evinacumab 450 mg SC treatment QW for 16 weeks during the DBTP followed by a 23-week follow-up period
|
Group B: Placebo IV Q4W (DBTP)
n=33 participants at risk
Placebo intravenous (IV) treatment every 4 weeks (Q4W) during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week open-label treatment period (OLTP) regardless of treatment assignment in the DBTP
|
Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)
n=36 participants at risk
Evinacumab 5 mg/kg IV treatment Q4W during the 24-week DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP
|
Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)
n=37 participants at risk
Evinacumab 15 mg/kg IV treatment Q4W during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP
|
Group B: Evinacumab 5 mg/kg IV Q4W (OLTP)
n=32 participants at risk
Evinacumab 5 mg/kg IV treatment Q4W during the 24-week DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP
|
Group B: Evinacumab 15 mg/kg IV Q4W (OLTP)
n=33 participants at risk
Evinacumab 15 mg/kg IV treatment Q4W during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/31 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/42 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/40 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
3.0%
1/33 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/36 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/37 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/32 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/31 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/42 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/40 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/36 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/37 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/32 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
3.0%
1/33 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/31 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/42 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/40 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/36 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/37 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
3.1%
1/32 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Cardiac disorders
Atrial fibrillation
|
3.2%
1/31 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/42 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/40 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/36 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.7%
1/37 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/32 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
3.0%
1/33 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/31 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.6%
1/39 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/42 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/40 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/36 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/37 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/32 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/31 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.4%
1/42 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/40 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/36 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/37 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/32 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/31 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.6%
1/39 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/42 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/40 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.8%
1/36 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.7%
1/37 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/32 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/31 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/42 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/40 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/36 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/37 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/32 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
3.0%
1/33 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/31 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.6%
1/39 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/42 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/40 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/36 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/37 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/32 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Gastrointestinal disorders
Gastrointestinal motility disorder
|
3.2%
1/31 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/42 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/40 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/36 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/37 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/32 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/31 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/42 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.5%
1/40 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/36 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/37 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/32 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/31 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.6%
1/39 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/42 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/40 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/36 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/37 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/32 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
General disorders
Chest pain
|
0.00%
0/31 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/42 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/40 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/36 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/37 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/32 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
3.0%
1/33 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
General disorders
General physical health deterioration
|
0.00%
0/31 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.4%
1/42 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/40 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/36 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/37 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/32 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Hepatobiliary disorders
Gallbladder polyp
|
0.00%
0/31 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/42 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/40 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/36 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/37 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
3.1%
1/32 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/31 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/42 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/40 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/36 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.7%
1/37 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/32 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/31 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/42 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.5%
1/40 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/36 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/37 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/32 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Infections and infestations
Corona virus infection
|
3.2%
1/31 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/42 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/40 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/36 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/37 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/32 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/31 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/42 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.5%
1/40 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/36 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/37 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/32 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/31 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.6%
1/39 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/42 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/40 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/36 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/37 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/32 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/31 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/42 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/40 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.8%
1/36 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/37 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/32 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/31 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/42 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/40 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/36 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.7%
1/37 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/32 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/31 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/42 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/40 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/36 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.7%
1/37 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/32 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/31 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/42 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/40 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/36 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/37 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
3.1%
1/32 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.00%
0/31 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.4%
1/42 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/40 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/36 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/37 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/32 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.00%
0/31 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/42 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/40 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/36 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.7%
1/37 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/32 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
3.2%
1/31 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/42 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/40 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/36 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/37 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/32 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Nervous system disorders
Carotid artery stenosis
|
3.2%
1/31 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/42 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/40 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/36 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/37 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/32 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Nervous system disorders
Hypertensive encephalopathy
|
0.00%
0/31 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/42 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/40 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.8%
1/36 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/37 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/32 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/31 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.6%
1/39 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/42 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/40 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/36 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/37 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/32 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Nervous system disorders
Seizure
|
0.00%
0/31 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.6%
1/39 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/42 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/40 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/36 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/37 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/32 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Nervous system disorders
Syncope
|
0.00%
0/31 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/42 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/40 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.8%
1/36 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/37 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/32 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/31 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.4%
1/42 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/40 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/36 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/37 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/32 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Renal and urinary disorders
Urinary bladder polyp
|
0.00%
0/31 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.4%
1/42 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/40 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/36 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/37 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/32 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Reproductive system and breast disorders
Acquired hydrocele
|
0.00%
0/31 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/42 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.5%
1/40 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/36 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/37 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/32 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/31 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/42 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/40 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/36 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.7%
1/37 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/32 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
Other adverse events
| Measure |
Group B: Placebo IV Q4W (OLTP)
n=31 participants at risk
Placebo intravenous (IV) treatment every 4 weeks (Q4W) during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week open-label treatment period (OLTP) regardless of treatment assignment in the DBTP
|
Group A: Placebo SC QW (DBTP)
n=39 participants at risk
Placebo subcutaneous (SC) treatment every week (QW) for 16 weeks during the double-blind treatment period (DBTP) followed by a 23-week follow-up period
|
Group A: Evinacumab 300 mg SC Q2W (DBTP)
n=39 participants at risk
Evinacumab 300 mg SC treatment every other week (Q2W) (alternating with placebo on opposite weeks) for 16 weeks during the DBTP followed by a 23-week follow-up period
|
Group A: Evinacumab 300 mg SC QW (DBTP)
n=42 participants at risk
Evinacumab 300 mg SC treatment QW for 16 weeks during the DBTP followed by a 23-week follow-up period
|
Group A: Evinacumab 450 mg SC QW (DBTP)
n=40 participants at risk
Evinacumab 450 mg SC treatment QW for 16 weeks during the DBTP followed by a 23-week follow-up period
|
Group B: Placebo IV Q4W (DBTP)
n=33 participants at risk
Placebo intravenous (IV) treatment every 4 weeks (Q4W) during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week open-label treatment period (OLTP) regardless of treatment assignment in the DBTP
|
Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)
n=36 participants at risk
Evinacumab 5 mg/kg IV treatment Q4W during the 24-week DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP
|
Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)
n=37 participants at risk
Evinacumab 15 mg/kg IV treatment Q4W during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP
|
Group B: Evinacumab 5 mg/kg IV Q4W (OLTP)
n=32 participants at risk
Evinacumab 5 mg/kg IV treatment Q4W during the 24-week DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP
|
Group B: Evinacumab 15 mg/kg IV Q4W (OLTP)
n=33 participants at risk
Evinacumab 15 mg/kg IV treatment Q4W during the DBTP followed by evinacumab 15 mg/kg IV Q4W for a 48-week OLTP regardless of treatment assignment in the DBTP
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.5%
2/31 • Number of events 3 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
10.3%
4/39 • Number of events 5 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.4%
1/42 • Number of events 3 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
5.0%
2/40 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
12.1%
4/33 • Number of events 5 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
13.9%
5/36 • Number of events 5 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
5.4%
2/37 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
3.1%
1/32 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.7%
3/31 • Number of events 3 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.6%
1/39 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
7.7%
3/39 • Number of events 3 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.4%
1/42 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
5.0%
2/40 • Number of events 3 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
9.1%
3/33 • Number of events 3 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
5.6%
2/36 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.7%
1/37 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
6.2%
2/32 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.5%
2/31 • Number of events 4 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
12.8%
5/39 • Number of events 6 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
7.7%
3/39 • Number of events 3 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
9.5%
4/42 • Number of events 5 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
5.0%
2/40 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
6.1%
2/33 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
8.3%
3/36 • Number of events 3 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
5.4%
2/37 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
9.4%
3/32 • Number of events 3 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
3.2%
1/31 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
5.1%
2/39 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.4%
1/42 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
7.5%
3/40 • Number of events 4 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
3.0%
1/33 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/36 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/37 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/32 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.2%
1/31 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.6%
1/39 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
5.1%
2/39 • Number of events 4 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.4%
1/42 • Number of events 4 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.5%
1/40 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/36 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/37 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/32 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.2%
1/31 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
5.1%
2/39 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
5.1%
2/39 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.4%
1/42 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
5.0%
2/40 • Number of events 4 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
8.3%
3/36 • Number of events 3 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
5.4%
2/37 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/32 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Nervous system disorders
Headache
|
12.9%
4/31 • Number of events 4 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
10.3%
4/39 • Number of events 7 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
5.1%
2/39 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
7.1%
3/42 • Number of events 5 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
10.0%
4/40 • Number of events 4 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
18.2%
6/33 • Number of events 10 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
5.6%
2/36 • Number of events 3 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
13.5%
5/37 • Number of events 6 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
6.2%
2/32 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
12.1%
4/33 • Number of events 6 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/31 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
12.8%
5/39 • Number of events 6 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.6%
1/39 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
4.8%
2/42 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.5%
1/40 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
5.6%
2/36 • Number of events 3 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
8.1%
3/37 • Number of events 3 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
3.1%
1/32 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/31 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/42 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
5.0%
2/40 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/36 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/37 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/32 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/31 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
7.7%
3/39 • Number of events 5 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.6%
1/39 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
4.8%
2/42 • Number of events 3 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
7.5%
3/40 • Number of events 17 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
6.1%
2/33 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.8%
1/36 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/37 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
9.4%
3/32 • Number of events 4 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
3.0%
1/33 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.2%
1/31 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.6%
1/39 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.6%
1/39 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/42 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/40 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
6.1%
2/33 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.8%
1/36 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.7%
1/37 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/32 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
6.1%
2/33 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
3.2%
1/31 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.6%
1/39 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/42 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.5%
1/40 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
6.1%
2/33 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/36 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.7%
1/37 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
3.1%
1/32 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
3.2%
1/31 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/42 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
5.0%
2/40 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/36 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/37 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/32 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.2%
1/31 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
10.3%
4/39 • Number of events 4 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.6%
1/39 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/42 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/40 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
5.6%
2/36 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
5.4%
2/37 • Number of events 5 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
3.1%
1/32 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/31 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.6%
1/39 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/42 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/40 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
5.6%
2/36 • Number of events 3 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/37 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
3.1%
1/32 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/31 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.6%
1/39 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
10.3%
4/39 • Number of events 4 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/42 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/40 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
5.6%
2/36 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.7%
1/37 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/32 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/31 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
7.7%
3/39 • Number of events 3 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
10.3%
4/39 • Number of events 4 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.4%
1/42 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
10.0%
4/40 • Number of events 21 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
5.6%
2/36 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
8.1%
3/37 • Number of events 3 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
3.1%
1/32 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
3.0%
1/33 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Gastrointestinal disorders
Toothache
|
6.5%
2/31 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
5.1%
2/39 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/42 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/40 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/36 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/37 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
3.1%
1/32 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
3.0%
1/33 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
General disorders
Influenza like illness
|
3.2%
1/31 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
5.1%
2/39 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/42 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
7.5%
3/40 • Number of events 8 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
9.1%
3/33 • Number of events 3 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
8.3%
3/36 • Number of events 3 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.7%
1/37 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
9.4%
3/32 • Number of events 4 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
12.1%
4/33 • Number of events 5 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
General disorders
Fatigue
|
9.7%
3/31 • Number of events 3 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
7.7%
3/39 • Number of events 3 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
4.8%
2/42 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
10.0%
4/40 • Number of events 15 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
6.1%
2/33 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
11.1%
4/36 • Number of events 4 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.7%
1/37 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
6.2%
2/32 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
General disorders
Asthenia
|
3.2%
1/31 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.6%
1/39 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.4%
1/42 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/40 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/36 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
8.1%
3/37 • Number of events 3 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/32 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
General disorders
Chest pain
|
9.7%
3/31 • Number of events 3 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.6%
1/39 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
7.1%
3/42 • Number of events 4 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.5%
1/40 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.8%
1/36 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
5.4%
2/37 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
3.1%
1/32 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
General disorders
Injection site bruising
|
0.00%
0/31 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
5.1%
2/39 • Number of events 11 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.6%
1/39 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.4%
1/42 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.5%
1/40 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/36 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/37 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/32 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
General disorders
Injection site erythema
|
0.00%
0/31 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.6%
1/39 • Number of events 4 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
5.1%
2/39 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.4%
1/42 • Number of events 4 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
10.0%
4/40 • Number of events 26 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.8%
1/36 • Number of events 10 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/37 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/32 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
General disorders
Injection site haematoma
|
0.00%
0/31 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
5.1%
2/39 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
7.1%
3/42 • Number of events 5 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/40 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/36 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/37 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/32 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/31 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.6%
1/39 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.6%
1/39 • Number of events 6 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
7.1%
3/42 • Number of events 3 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/40 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/36 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/37 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/32 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
General disorders
Injection site pain
|
0.00%
0/31 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
5.1%
2/39 • Number of events 6 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.4%
1/42 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.5%
1/40 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/36 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/37 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/32 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
General disorders
Injection site reaction
|
0.00%
0/31 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
5.1%
2/39 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/42 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/40 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/36 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/37 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/32 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/31 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.4%
1/42 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
5.0%
2/40 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/36 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.7%
1/37 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/32 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
General disorders
Oedema peripheral
|
0.00%
0/31 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.6%
1/39 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.4%
1/42 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
7.5%
3/40 • Number of events 3 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/36 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/37 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/32 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Infections and infestations
Nasopharyngitis
|
16.1%
5/31 • Number of events 7 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
15.4%
6/39 • Number of events 7 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
10.3%
4/39 • Number of events 5 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
9.5%
4/42 • Number of events 5 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
10.0%
4/40 • Number of events 6 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
6.1%
2/33 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
8.3%
3/36 • Number of events 4 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
16.2%
6/37 • Number of events 6 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
12.5%
4/32 • Number of events 4 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
9.1%
3/33 • Number of events 4 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/31 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.4%
1/42 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
5.0%
2/40 • Number of events 3 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
3.0%
1/33 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/36 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/37 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
6.2%
2/32 • Number of events 3 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
6.1%
2/33 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/31 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.6%
1/39 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/42 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.5%
1/40 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/36 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/37 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
9.4%
3/32 • Number of events 3 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
3.0%
1/33 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Infections and infestations
Cystitis
|
6.5%
2/31 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
4.8%
2/42 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/40 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/36 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.7%
1/37 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/32 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Infections and infestations
Influenza
|
3.2%
1/31 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
5.1%
2/39 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.4%
1/42 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/40 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/36 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.7%
1/37 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/32 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
6.1%
2/33 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Infections and infestations
Oral herpes
|
3.2%
1/31 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/42 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.5%
1/40 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.8%
1/36 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/37 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
6.2%
2/32 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/31 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/42 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/40 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/36 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.7%
1/37 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/32 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
9.1%
3/33 • Number of events 4 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Infections and infestations
Sinusitis
|
3.2%
1/31 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
5.1%
2/39 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/42 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.5%
1/40 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.8%
1/36 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.7%
1/37 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
6.2%
2/32 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.5%
2/31 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
4.8%
2/42 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
5.0%
2/40 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.8%
1/36 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.7%
1/37 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
9.4%
3/32 • Number of events 4 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
9.1%
3/33 • Number of events 3 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Infections and infestations
Urinary tract infection
|
6.5%
2/31 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
10.3%
4/39 • Number of events 7 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
12.8%
5/39 • Number of events 6 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
11.9%
5/42 • Number of events 6 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
10.0%
4/40 • Number of events 6 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
5.6%
2/36 • Number of events 3 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/37 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
18.8%
6/32 • Number of events 8 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
9.1%
3/33 • Number of events 7 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.2%
1/31 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
5.1%
2/39 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.6%
1/39 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
7.1%
3/42 • Number of events 3 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
5.0%
2/40 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
6.1%
2/33 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/36 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.7%
1/37 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
6.2%
2/32 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/31 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.4%
1/42 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
5.0%
2/40 • Number of events 3 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.8%
1/36 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/37 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/32 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.5%
2/31 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.6%
1/39 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
4.8%
2/42 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/40 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/36 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.7%
1/37 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
3.1%
1/32 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/31 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
5.1%
2/39 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
9.5%
4/42 • Number of events 4 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/40 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.8%
1/36 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/37 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
6.2%
2/32 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/31 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
5.1%
2/39 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
4.8%
2/42 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/40 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
3.0%
1/33 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/36 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/37 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/32 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/31 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/42 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/40 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
3.0%
1/33 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/36 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.7%
1/37 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/32 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
6.1%
2/33 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Vascular disorders
Hypertension
|
3.2%
1/31 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.6%
1/39 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/42 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.5%
1/40 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
3.0%
1/33 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
8.3%
3/36 • Number of events 3 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/37 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/32 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/31 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/42 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
5.0%
2/40 • Number of events 3 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/36 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/37 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/32 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/31 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/42 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
5.0%
2/40 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.8%
1/36 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/37 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/32 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/31 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.6%
1/39 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
5.1%
2/39 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.4%
1/42 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.5%
1/40 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.8%
1/36 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/37 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
6.2%
2/32 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/31 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.6%
1/39 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
9.5%
4/42 • Number of events 4 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/40 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.8%
1/36 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/37 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
3.1%
1/32 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Investigations
Blood creatine phosphokinase increased
|
6.5%
2/31 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.6%
1/39 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/42 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/40 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/36 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/37 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/32 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
3.0%
1/33 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Investigations
Body temperature increased
|
0.00%
0/31 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/42 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
5.0%
2/40 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/36 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/37 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/32 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/31 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/42 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/40 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
8.3%
3/36 • Number of events 3 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/37 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/32 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/31 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
5.1%
2/39 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.6%
1/39 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/42 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.5%
1/40 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/36 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/37 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
3.1%
1/32 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/31 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.6%
1/39 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/42 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/40 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/36 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/37 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
6.2%
2/32 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
3.0%
1/33 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Psychiatric disorders
Depression
|
3.2%
1/31 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
5.1%
2/39 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/39 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.4%
1/42 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/40 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/36 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.7%
1/37 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
3.1%
1/32 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
|
Psychiatric disorders
Insomnia
|
3.2%
1/31 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.6%
1/39 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
2.6%
1/39 • Number of events 1 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/42 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/40 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
5.6%
2/36 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/37 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
6.2%
2/32 • Number of events 2 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
0.00%
0/33 • Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks
1 participant randomized to the "Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)" arm inadvertently received evinacumab 5 mg/kg IV at all double-blind administration visits. Per the study statistical analysis plan (SAP), this participant's safety data was analyzed as treated in the "Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)" arm.
|
Additional Information
Clinical Trials Administrator
Regeneron Pharmaceuticals, Inc.
Phone: 8447346643
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.
- Publication restrictions are in place
Restriction type: OTHER