Trial Outcomes & Findings for A Study of Alirocumab in Participants With Autosomal Dominant Hypercholesterolemia (ADH) and Gain-of-Function Mutations (GOFm) of the Proprotein Convertase Subtilisin Kexin 9 (PCSK9) Gene or Loss-of-Function Mutations (LOFm) of the Apolipoprotein (Apo) B Gene (NCT NCT01604824)
NCT ID: NCT01604824
Last Updated: 2020-06-17
Results Overview
By day 15, participants in groups A and C had received 1 subcutaneous (SC) dose of 150 mg alirocumab and participants in group B and D had received 1 SC dose of placebo. \[Baseline adjusted least squares (LS) means and standard errors were obtained using analysis of covariance (ANCOVA) model specifying the treatment arm as the fixed effect and the baseline measured LDL-C value as a covariate.\]
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
23 participants
Primary outcome timeframe
Baseline to Day 15
Results posted on
2020-06-17
Participant Flow
This study was conducted at 4 sites, 3 in France \& 1 in the United States. Twenty-eight participants were screened between Feb 2012 \& Apr 2013. A total of 23 participants were enrolled: 13 in cohort 1 \& 10 in cohort 2. Recruitment for cohort 2 occurred after the un-blinding of cohort 1 \& analyses of the double-blind study data for cohort 1.
Eligible participants entered a 2-wk, single-blind, placebo run-in period. Participants in cohort 1 were randomized in a 1:1 ratio (group A or B); Participants in cohort 2 were also randomized in a 1:1 ratio (group C or D).
Participant milestones
| Measure |
PCSK9 GOFm: Alirocumab From Day 1 (Cohort 1: Group A)
Participants with a gain-of-function mutation (GOFm) in the PCSK9 gene (Cohort 1: Group A) received 150 mg alirocumab subcutaneously (SC) on days 1, 15, 29, 43, and 71 and matching placebo SC on days 57, 85, and 99 during the double-blind period. Participants who continued in an open-label extension period received 150 mg alirocumab SC twice per week (Q2W) for an additional 3 years.
|
PCSK9 GOFm: Alirocumab From Day 15 (Cohort 1: Group B)
Participants with a GOFm in PCSK9 gene (Cohort 1: Group B) received 150 mg alirocumab SC on days 15, 29, 43, 57, and 85 and matching placebo SC on days 1, 71, and 99 during the double-blind period. Participants who continued in an open-label extension period received 150 mg alirocumab SC twice per week (Q2W) for an additional 3 years.
|
PCSK9 GOFm/ApoB LOFm: Alirocumab From Day1 (Cohort 2: Group C)
Participants with a GOFm in the PCSK9 gene or a LOFm in the Apo B gene (Cohort 2: Group C) received 150 mg alirocumab SC on days 1, 15, 29, 43, and 71 and matching placebo SC on days 57, 85, and 99. Participants who continued in an open-label extension period received 150 mg alirocumab SC twice per week (Q2W) for an additional 3 years.
|
PCSK9GOFm/ApoB LOFm: Alirocumab From Day 15(Cohort 2: Group D)
Participants with a GOFm in PCSK9 gene or LOFm in Apo B gene (Cohort 2: Group D) received 150 mg alirocumab SC on days 15, 29, 43, 57, and 85 and matching placebo SC on days 1, 71, and 99 during the double-blind period. Participants who continued in an open-label extension period received 150 mg alirocumab SC twice per week (Q2W) for an additional 3 years.
|
PCSK9 GOFm (Cohort 1: Group A and Group B)
Participants with a GOFm in the PCSK9 gene (Cohort 1: Group A) received 150 mg alirocumab subcutaneously (SC) on days 1, 15, 29, 43, and 71 and matching placebo SC on days 57, 85, and 99 during the double-blind period. Participants with a GOFm in PCSK9 gene (Cohort 1: Group B) received 150 mg alirocumab SC on days 15, 29, 43, 57, and 85 and matching placebo SC on days 1, 71, and 99 during the double-blind period. Participants who continued in an open-label extension period received 150 mg alirocumab SC, Q2W for an additional 3 years.
|
PCSK9 GOFm/ApoB LOFm (Cohort 2: Group C and Group D)
Participants with a GOFm in the PCSK9 gene or a LOFm in the Apo B gene (Cohort 2: Group C) received 150 mg alirocumab SC on days 1, 15, 29, 43, and 71 and matching placebo SC on days 57, 85, and 99. Participants with a GOFm in PCSK9 gene or LOFm in Apo B gene (Cohort 2: Group D) received 150 mg alirocumab SC on days 15, 29, 43, 57, and 85 and matching placebo SC on days 1, 71, and 99 during the double-blind period. Participants who continued in an open-label extension period received 150 mg alirocumab SC twice per week (Q2W) for an additional 3 years.
|
|---|---|---|---|---|---|---|
|
Double-blind (DB) Period
STARTED
|
6
|
7
|
5
|
5
|
0
|
0
|
|
Double-blind (DB) Period
Completed DB Period (Day 99)
|
6
|
7
|
5
|
5
|
0
|
0
|
|
Double-blind (DB) Period
Completed DB Follow-up (Day 155)
|
6
|
7
|
5
|
5
|
0
|
0
|
|
Double-blind (DB) Period
COMPLETED
|
6
|
7
|
5
|
5
|
0
|
0
|
|
Double-blind (DB) Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Open-label Extension (OLE) Period
STARTED
|
0
|
0
|
0
|
0
|
13
|
10
|
|
Open-label Extension (OLE) Period
Started Open-label Extension Period
|
0
|
0
|
0
|
0
|
11
|
10
|
|
Open-label Extension (OLE) Period
Completed Study
|
0
|
0
|
0
|
0
|
10
|
10
|
|
Open-label Extension (OLE) Period
COMPLETED
|
0
|
0
|
0
|
0
|
10
|
10
|
|
Open-label Extension (OLE) Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
3
|
0
|
Reasons for withdrawal
| Measure |
PCSK9 GOFm: Alirocumab From Day 1 (Cohort 1: Group A)
Participants with a gain-of-function mutation (GOFm) in the PCSK9 gene (Cohort 1: Group A) received 150 mg alirocumab subcutaneously (SC) on days 1, 15, 29, 43, and 71 and matching placebo SC on days 57, 85, and 99 during the double-blind period. Participants who continued in an open-label extension period received 150 mg alirocumab SC twice per week (Q2W) for an additional 3 years.
|
PCSK9 GOFm: Alirocumab From Day 15 (Cohort 1: Group B)
Participants with a GOFm in PCSK9 gene (Cohort 1: Group B) received 150 mg alirocumab SC on days 15, 29, 43, 57, and 85 and matching placebo SC on days 1, 71, and 99 during the double-blind period. Participants who continued in an open-label extension period received 150 mg alirocumab SC twice per week (Q2W) for an additional 3 years.
|
PCSK9 GOFm/ApoB LOFm: Alirocumab From Day1 (Cohort 2: Group C)
Participants with a GOFm in the PCSK9 gene or a LOFm in the Apo B gene (Cohort 2: Group C) received 150 mg alirocumab SC on days 1, 15, 29, 43, and 71 and matching placebo SC on days 57, 85, and 99. Participants who continued in an open-label extension period received 150 mg alirocumab SC twice per week (Q2W) for an additional 3 years.
|
PCSK9GOFm/ApoB LOFm: Alirocumab From Day 15(Cohort 2: Group D)
Participants with a GOFm in PCSK9 gene or LOFm in Apo B gene (Cohort 2: Group D) received 150 mg alirocumab SC on days 15, 29, 43, 57, and 85 and matching placebo SC on days 1, 71, and 99 during the double-blind period. Participants who continued in an open-label extension period received 150 mg alirocumab SC twice per week (Q2W) for an additional 3 years.
|
PCSK9 GOFm (Cohort 1: Group A and Group B)
Participants with a GOFm in the PCSK9 gene (Cohort 1: Group A) received 150 mg alirocumab subcutaneously (SC) on days 1, 15, 29, 43, and 71 and matching placebo SC on days 57, 85, and 99 during the double-blind period. Participants with a GOFm in PCSK9 gene (Cohort 1: Group B) received 150 mg alirocumab SC on days 15, 29, 43, 57, and 85 and matching placebo SC on days 1, 71, and 99 during the double-blind period. Participants who continued in an open-label extension period received 150 mg alirocumab SC, Q2W for an additional 3 years.
|
PCSK9 GOFm/ApoB LOFm (Cohort 2: Group C and Group D)
Participants with a GOFm in the PCSK9 gene or a LOFm in the Apo B gene (Cohort 2: Group C) received 150 mg alirocumab SC on days 1, 15, 29, 43, and 71 and matching placebo SC on days 57, 85, and 99. Participants with a GOFm in PCSK9 gene or LOFm in Apo B gene (Cohort 2: Group D) received 150 mg alirocumab SC on days 15, 29, 43, 57, and 85 and matching placebo SC on days 1, 71, and 99 during the double-blind period. Participants who continued in an open-label extension period received 150 mg alirocumab SC twice per week (Q2W) for an additional 3 years.
|
|---|---|---|---|---|---|---|
|
Open-label Extension (OLE) Period
Chose not to enter OLE Period
|
0
|
0
|
0
|
0
|
2
|
0
|
|
Open-label Extension (OLE) Period
Refused to come into office
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study of Alirocumab in Participants With Autosomal Dominant Hypercholesterolemia (ADH) and Gain-of-Function Mutations (GOFm) of the Proprotein Convertase Subtilisin Kexin 9 (PCSK9) Gene or Loss-of-Function Mutations (LOFm) of the Apolipoprotein (Apo) B Gene
Baseline characteristics by cohort
| Measure |
PCSK9 GOFm: Alirocumab From Day 1 (Cohort 1: Group A)
n=6 Participants
Participants with a gain-of-function mutation (GOFm) in the PCSK9 gene (Cohort 1: Group A) received 150 mg alirocumab subcutaneously (SC) on days 1, 15, 29, 43, and 71 and matching placebo SC on days 57, 85, and 99 during the double-blind period. Participants who continued in an open-label extension period received 150 mg alirocumab SC twice per week (Q2W) for an additional 3 years.
|
PCSK9 GOFm: Alirocumab From Day 15 (Cohort 1: Group B)
n=7 Participants
Participants with a GOFm in PCSK9 gene (Cohort 1: Group B) received 150 mg alirocumab SC on days 15, 29, 43, 57, and 85 and matching placebo SC on days 1, 71, and 99 during the double-blind period. Participants who continued in an open-label extension period received 150 mg alirocumab SC twice per week (Q2W) for an additional 3 years.
|
PCSK9 GOFm/ApoB LOFm: Alirocumab From Day1 (Cohort 2: Group C)
n=5 Participants
Participants with a GOFm in the PCSK9 gene or a LOFm in the Apo B gene (Cohort 2: Group C) received 150 mg alirocumab SC on days 1, 15, 29, 43, and 71 and matching placebo SC on days 57, 85, and 99. Participants who continued in an open-label extension period received 150 mg alirocumab SC twice per week (Q2W) for an additional 3 years.
|
PCSK9GOFm/ApoB LOFm: Alirocumab From Day 15(Cohort 2: Group D)
n=5 Participants
Participants with a GOFm in PCSK9 gene or LOFm in Apo B gene (Cohort 2: Group D) received 150 mg alirocumab SC on days 15, 29, 43, 57, and 85 and matching placebo SC on days 1, 71, and 99 during the double-blind period. Participants who continued in an open-label extension period received 150 mg alirocumab SC twice per week (Q2W) for an additional 3 years.
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
42.3 years
STANDARD_DEVIATION 14.72 • n=5 Participants
|
46.4 years
STANDARD_DEVIATION 13.24 • n=7 Participants
|
45.6 years
STANDARD_DEVIATION 3.21 • n=5 Participants
|
42.0 years
STANDARD_DEVIATION 10.84 • n=4 Participants
|
44.2 years
STANDARD_DEVIATION 11.15 • n=21 Participants
|
|
Age, Customized
In utero
|
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
|
|
Age, Customized
Preterm newborn infants (gestational age < 37 wks)
|
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
|
|
Age, Customized
Newborns (0-27 days)
|
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
|
|
Age, Customized
Infants and toddlers (28 days-23 months)
|
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
|
|
Age, Customized
Children (2-11 years)
|
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
|
|
Age, Customized
Adolescents (12-17 years)
|
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
|
|
Age, Customized
Adults (18-64 years)
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Age, Customized
From 65-84 years
|
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
|
|
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
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
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
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (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
|
|
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
|
|
Race (NIH/OMB)
Other: Indian Ocean Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Other: Mauritius
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Measured Low-Density Lipoprotein Cholesterol (LDL-C)
|
108.8 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 33.84 • n=5 Participants
|
144.3 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 68.39 • n=7 Participants
|
187.4 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 98.12 • n=5 Participants
|
151.0 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 82.70 • n=4 Participants
|
145.9 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 72.82 • n=21 Participants
|
|
Total Cholesterol
|
181.3 mg/dL
STANDARD_DEVIATION 41.89 • n=5 Participants
|
216.3 mg/dL
STANDARD_DEVIATION 78.61 • n=7 Participants
|
249.8 mg/dL
STANDARD_DEVIATION 86.68 • n=5 Participants
|
226.0 mg/dL
STANDARD_DEVIATION 77.80 • n=4 Participants
|
216.6 mg/dL
STANDARD_DEVIATION 71.84 • n=21 Participants
|
|
Non-high-density lipoprotein cholesterol (Non-HDL-C)
|
124.3 mg/dL
STANDARD_DEVIATION 49.00 • n=5 Participants
|
165.9 mg/dL
STANDARD_DEVIATION 75.59 • n=7 Participants
|
189.4 mg/dL
STANDARD_DEVIATION 93.43 • n=5 Participants
|
163.4 mg/dL
STANDARD_DEVIATION 86.88 • n=4 Participants
|
159.6 mg/dL
STANDARD_DEVIATION 74.97 • n=21 Participants
|
|
Apolipoprotein (Apo) B100
|
89.2 mg/dL
STANDARD_DEVIATION 27.29 • n=5 Participants
|
101.0 mg/dL
STANDARD_DEVIATION 15.77 • n=7 Participants
|
129.4 mg/dL
STANDARD_DEVIATION 58.27 • n=5 Participants
|
103.6 mg/dL
STANDARD_DEVIATION 42.83 • n=4 Participants
|
104.7 mg/dL
STANDARD_DEVIATION 37.38 • n=21 Participants
|
|
Apolipoprotein (Apo) A1
|
136.3 mg/dL
STANDARD_DEVIATION 29.75 • n=5 Participants
|
131.4 mg/dL
STANDARD_DEVIATION 30.02 • n=7 Participants
|
154.0 mg/dL
STANDARD_DEVIATION 10.98 • n=5 Participants
|
154.8 mg/dL
STANDARD_DEVIATION 20.36 • n=4 Participants
|
142.7 mg/dL
STANDARD_DEVIATION 25.65 • n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 15By day 15, participants in groups A and C had received 1 subcutaneous (SC) dose of 150 mg alirocumab and participants in group B and D had received 1 SC dose of placebo. \[Baseline adjusted least squares (LS) means and standard errors were obtained using analysis of covariance (ANCOVA) model specifying the treatment arm as the fixed effect and the baseline measured LDL-C value as a covariate.\]
Outcome measures
| Measure |
PCSK9 GOFm: Alirocumab From Day 1 (Cohort 1: Group A)
n=6 Participants
Participants with a gain-of-function mutation (GOFm) in the PCSK9 gene (Cohort 1: Group A) received 150 mg alirocumab subcutaneously (SC) on days 1, 15, 29, 43, and 71 and matching placebo SC on days 57, 85, and 99 during the double-blind period. Participants who continued in an open-label extension period received 150 mg alirocumab SC twice per week (Q2W) for an additional 3 years.
|
PCSK9 GOFm: Alirocumab From Day 15 (Cohort 1: Group B)
n=7 Participants
Participants with a GOFm in PCSK9 gene (Cohort 1: Group B) received 150 mg alirocumab SC on days 15, 29, 43, 57, and 85 and matching placebo SC on days 1, 71, and 99 during the double-blind period. Participants who continued in an open-label extension period received 150 mg alirocumab SC twice per week (Q2W) for an additional 3 years.
|
PCSK9 GOFm/ApoB LOFm: Alirocumab From Day1 (Cohort 2: Group C)
n=5 Participants
Participants with a GOFm in the PCSK9 gene or a LOFm in the Apo B gene (Cohort 2: Group C) received 150 mg alirocumab SC on days 1, 15, 29, 43, and 71 and matching placebo SC on days 57, 85, and 99. Participants who continued in an open-label extension period received 150 mg alirocumab SC twice per week (Q2W) for an additional 3 years.
|
PCSK9GOFm/ApoB LOFm: Alirocumab From Day 15(Cohort 2: Group D)
n=5 Participants
Participants with a GOFm in PCSK9 gene or LOFm in Apo B gene (Cohort 2: Group D) received 150 mg alirocumab SC on days 15, 29, 43, 57, and 85 and matching placebo SC on days 1, 71, and 99 during the double-blind period. Participants who continued in an open-label extension period received 150 mg alirocumab SC twice per week (Q2W) for an additional 3 years.
|
|---|---|---|---|---|
|
Percent Change in Measured Serum Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 15
|
-62.48 percent change
Standard Error 8.217 • Interval 8.217 to
|
-8.77 percent change
Standard Error 7.575 • Interval 7.575 to
|
-48.21 percent change
Standard Error 7.660 • Interval 7.66 to
|
-4.93 percent change
Standard Error 7.660 • Interval 7.66 to
|
SECONDARY outcome
Timeframe: Baseline to Day 15Baseline adjusted LS means and standard errors were obtained using the same ANCOVA model as for primary endpoint specifying the treatment arm as the fixed effect and the parameter value as a covariate.
Outcome measures
| Measure |
PCSK9 GOFm: Alirocumab From Day 1 (Cohort 1: Group A)
n=6 Participants
Participants with a gain-of-function mutation (GOFm) in the PCSK9 gene (Cohort 1: Group A) received 150 mg alirocumab subcutaneously (SC) on days 1, 15, 29, 43, and 71 and matching placebo SC on days 57, 85, and 99 during the double-blind period. Participants who continued in an open-label extension period received 150 mg alirocumab SC twice per week (Q2W) for an additional 3 years.
|
PCSK9 GOFm: Alirocumab From Day 15 (Cohort 1: Group B)
n=7 Participants
Participants with a GOFm in PCSK9 gene (Cohort 1: Group B) received 150 mg alirocumab SC on days 15, 29, 43, 57, and 85 and matching placebo SC on days 1, 71, and 99 during the double-blind period. Participants who continued in an open-label extension period received 150 mg alirocumab SC twice per week (Q2W) for an additional 3 years.
|
PCSK9 GOFm/ApoB LOFm: Alirocumab From Day1 (Cohort 2: Group C)
n=5 Participants
Participants with a GOFm in the PCSK9 gene or a LOFm in the Apo B gene (Cohort 2: Group C) received 150 mg alirocumab SC on days 1, 15, 29, 43, and 71 and matching placebo SC on days 57, 85, and 99. Participants who continued in an open-label extension period received 150 mg alirocumab SC twice per week (Q2W) for an additional 3 years.
|
PCSK9GOFm/ApoB LOFm: Alirocumab From Day 15(Cohort 2: Group D)
n=5 Participants
Participants with a GOFm in PCSK9 gene or LOFm in Apo B gene (Cohort 2: Group D) received 150 mg alirocumab SC on days 15, 29, 43, 57, and 85 and matching placebo SC on days 1, 71, and 99 during the double-blind period. Participants who continued in an open-label extension period received 150 mg alirocumab SC twice per week (Q2W) for an additional 3 years.
|
|---|---|---|---|---|
|
Percent Change in Apolipoprotein (Apo) B100 From Baseline to Day 15
|
-53.33 percent change
Standard Error 8.678 • Interval 8.678 to
|
-3.78 percent change
Standard Error 8.008 • Interval 8.008 to
|
-47.73 percent change
Standard Error 7.547 • Interval 7.547 to
|
-3.09 percent change
Standard Error 7.547 • Interval 7.547 to
|
SECONDARY outcome
Timeframe: Baseline to Day 15Outcome measures
| Measure |
PCSK9 GOFm: Alirocumab From Day 1 (Cohort 1: Group A)
n=6 Participants
Participants with a gain-of-function mutation (GOFm) in the PCSK9 gene (Cohort 1: Group A) received 150 mg alirocumab subcutaneously (SC) on days 1, 15, 29, 43, and 71 and matching placebo SC on days 57, 85, and 99 during the double-blind period. Participants who continued in an open-label extension period received 150 mg alirocumab SC twice per week (Q2W) for an additional 3 years.
|
PCSK9 GOFm: Alirocumab From Day 15 (Cohort 1: Group B)
n=7 Participants
Participants with a GOFm in PCSK9 gene (Cohort 1: Group B) received 150 mg alirocumab SC on days 15, 29, 43, 57, and 85 and matching placebo SC on days 1, 71, and 99 during the double-blind period. Participants who continued in an open-label extension period received 150 mg alirocumab SC twice per week (Q2W) for an additional 3 years.
|
PCSK9 GOFm/ApoB LOFm: Alirocumab From Day1 (Cohort 2: Group C)
n=5 Participants
Participants with a GOFm in the PCSK9 gene or a LOFm in the Apo B gene (Cohort 2: Group C) received 150 mg alirocumab SC on days 1, 15, 29, 43, and 71 and matching placebo SC on days 57, 85, and 99. Participants who continued in an open-label extension period received 150 mg alirocumab SC twice per week (Q2W) for an additional 3 years.
|
PCSK9GOFm/ApoB LOFm: Alirocumab From Day 15(Cohort 2: Group D)
n=5 Participants
Participants with a GOFm in PCSK9 gene or LOFm in Apo B gene (Cohort 2: Group D) received 150 mg alirocumab SC on days 15, 29, 43, 57, and 85 and matching placebo SC on days 1, 71, and 99 during the double-blind period. Participants who continued in an open-label extension period received 150 mg alirocumab SC twice per week (Q2W) for an additional 3 years.
|
|---|---|---|---|---|
|
Percent Change in Non High-Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Day 15
|
-56.87 percent change
Standard Error 8.217 • Interval 8.217 to
|
-7.50 percent change
Standard Error 7.575 • Interval 7.575 to
|
-44.40 percent change
Standard Error 7.357 • Interval 7.357 to
|
-4.04 percent change
Standard Error 7.357 • Interval 7.357 to
|
SECONDARY outcome
Timeframe: Baseline to Day 15Outcome measures
| Measure |
PCSK9 GOFm: Alirocumab From Day 1 (Cohort 1: Group A)
n=6 Participants
Participants with a gain-of-function mutation (GOFm) in the PCSK9 gene (Cohort 1: Group A) received 150 mg alirocumab subcutaneously (SC) on days 1, 15, 29, 43, and 71 and matching placebo SC on days 57, 85, and 99 during the double-blind period. Participants who continued in an open-label extension period received 150 mg alirocumab SC twice per week (Q2W) for an additional 3 years.
|
PCSK9 GOFm: Alirocumab From Day 15 (Cohort 1: Group B)
n=7 Participants
Participants with a GOFm in PCSK9 gene (Cohort 1: Group B) received 150 mg alirocumab SC on days 15, 29, 43, 57, and 85 and matching placebo SC on days 1, 71, and 99 during the double-blind period. Participants who continued in an open-label extension period received 150 mg alirocumab SC twice per week (Q2W) for an additional 3 years.
|
PCSK9 GOFm/ApoB LOFm: Alirocumab From Day1 (Cohort 2: Group C)
n=5 Participants
Participants with a GOFm in the PCSK9 gene or a LOFm in the Apo B gene (Cohort 2: Group C) received 150 mg alirocumab SC on days 1, 15, 29, 43, and 71 and matching placebo SC on days 57, 85, and 99. Participants who continued in an open-label extension period received 150 mg alirocumab SC twice per week (Q2W) for an additional 3 years.
|
PCSK9GOFm/ApoB LOFm: Alirocumab From Day 15(Cohort 2: Group D)
n=5 Participants
Participants with a GOFm in PCSK9 gene or LOFm in Apo B gene (Cohort 2: Group D) received 150 mg alirocumab SC on days 15, 29, 43, 57, and 85 and matching placebo SC on days 1, 71, and 99 during the double-blind period. Participants who continued in an open-label extension period received 150 mg alirocumab SC twice per week (Q2W) for an additional 3 years.
|
|---|---|---|---|---|
|
Percent Change in Total Cholesterol (Total-C) From Baseline to Day 15
|
-36.94 percent change
Standard Error 5.203 • Interval 5.203 to
|
-6.18 percent change
Standard Error 4.802 • Interval 4.802 to
|
-29.40 percent change
Standard Error 4.422 • Interval 4.422 to
|
-7.18 percent change
Standard Error 4.422 • Interval 4.422 to
|
SECONDARY outcome
Timeframe: Baseline to Day 15Outcome measures
| Measure |
PCSK9 GOFm: Alirocumab From Day 1 (Cohort 1: Group A)
n=6 Participants
Participants with a gain-of-function mutation (GOFm) in the PCSK9 gene (Cohort 1: Group A) received 150 mg alirocumab subcutaneously (SC) on days 1, 15, 29, 43, and 71 and matching placebo SC on days 57, 85, and 99 during the double-blind period. Participants who continued in an open-label extension period received 150 mg alirocumab SC twice per week (Q2W) for an additional 3 years.
|
PCSK9 GOFm: Alirocumab From Day 15 (Cohort 1: Group B)
n=7 Participants
Participants with a GOFm in PCSK9 gene (Cohort 1: Group B) received 150 mg alirocumab SC on days 15, 29, 43, 57, and 85 and matching placebo SC on days 1, 71, and 99 during the double-blind period. Participants who continued in an open-label extension period received 150 mg alirocumab SC twice per week (Q2W) for an additional 3 years.
|
PCSK9 GOFm/ApoB LOFm: Alirocumab From Day1 (Cohort 2: Group C)
n=5 Participants
Participants with a GOFm in the PCSK9 gene or a LOFm in the Apo B gene (Cohort 2: Group C) received 150 mg alirocumab SC on days 1, 15, 29, 43, and 71 and matching placebo SC on days 57, 85, and 99. Participants who continued in an open-label extension period received 150 mg alirocumab SC twice per week (Q2W) for an additional 3 years.
|
PCSK9GOFm/ApoB LOFm: Alirocumab From Day 15(Cohort 2: Group D)
n=5 Participants
Participants with a GOFm in PCSK9 gene or LOFm in Apo B gene (Cohort 2: Group D) received 150 mg alirocumab SC on days 15, 29, 43, 57, and 85 and matching placebo SC on days 1, 71, and 99 during the double-blind period. Participants who continued in an open-label extension period received 150 mg alirocumab SC twice per week (Q2W) for an additional 3 years.
|
|---|---|---|---|---|
|
Percent Change in Apolipoprotein (Apo) B100/ ApoA-1 Ratio From Baseline to Day 15
|
-55.26 percent change
Standard Error 7.188 • Interval 7.188 to
|
-5.53 percent change
Standard Error 6.647 • Interval 6.647 to
|
-48.34 percent change
Standard Error 8.090 • Interval 8.09 to
|
0.99 percent change
Standard Error 8.090 • Interval 8.09 to
|
Adverse Events
PCSK9 GOFm: Alirocumab From Day 1 (Cohort 1: Group A)
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
PCSK9 GOFm: Alirocumab From Day 15 (Cohort 1: Group B)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
PCSK9 GOFm/ApoB LOFm: Alirocumab From Day1 (Cohort 2: Group C)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
PCSK9GOFm/ApoB LOFm: Alirocumab From Day 15(Cohort 2:Group D)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
OLE Period: PCSK9 GOFm (Cohort 1) Group A & Group B
Serious events: 3 serious events
Other events: 10 other events
Deaths: 0 deaths
OLE Period: PCSK9 GOFm/ ApoB LOFm (Cohort 2) Group C & Group D
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PCSK9 GOFm: Alirocumab From Day 1 (Cohort 1: Group A)
n=6 participants at risk
Participants with a gain-of-function mutation (GOFm) in the PCSK9 gene (Cohort 1: Group A) received 150 mg alirocumab subcutaneously (SC) on days 1, 15, 29, 43, and 71 and matching placebo SC on days 57, 85, and 99 during the double-blind period. Participants who continued in an open-label extension period received 150 mg alirocumab SC twice per week (Q2W) for an additional 3 years.
|
PCSK9 GOFm: Alirocumab From Day 15 (Cohort 1: Group B)
n=7 participants at risk
Participants with a GOFm in PCSK9 gene (Cohort 1: Group B) received 150 mg alirocumab SC on days 15, 29, 43, 57, and 85 and matching placebo SC on days 1, 71, and 99 during the double-blind period. Participants who continued in an open-label extension period received 150 mg alirocumab SC twice per week (Q2W) for an additional 3 years.
|
PCSK9 GOFm/ApoB LOFm: Alirocumab From Day1 (Cohort 2: Group C)
n=5 participants at risk
Participants with a GOFm in the PCSK9 gene or a LOFm in the Apo B gene (Cohort 2: Group C) received 150 mg alirocumab SC on days 1, 15, 29, 43, and 71 and matching placebo SC on days 57, 85, and 99. Participants who continued in an open-label extension period received 150 mg alirocumab SC twice per week (Q2W) for an additional 3 years.
|
PCSK9GOFm/ApoB LOFm: Alirocumab From Day 15(Cohort 2:Group D)
n=5 participants at risk
Subjects with a GOFm in PCSK9 gene or LOFm in Apo B gene (Cohort 2: Group D) received 150 mg alirocumab SC on days 15, 29, 43, 57, and 85 and matching placebo SC on days 1, 71, and 99 during the double-blind period. Afterwards, subjects continued in an open-label extension period with 150 mg alirocumab SC twice per week (Q2W) for an additional 3 years.
|
OLE Period: PCSK9 GOFm (Cohort 1) Group A & Group B
n=11 participants at risk
Subjects with a GOFm in PCSK9 gene (Cohort 1): alirocumab 150 mg subcutaneous (SC) injection at Week 0 (Day 1), Week 2 (Day 15), Weeks 4, 6 and 10 (matching placebo at Week 8, 12 and 14) during the double-blind period (Group A) or at Week 2 (Day 15), Weeks 4, 6, 8 and 12 (matching placebo at Week 0 \[Day 1\], Weeks 10 and 14) during the double-blind period (Group B). Afterwards, subjects continued in an OLE period with 150 mg alirocumab SC twice per week (Q2W) for an additional 3 years.
|
OLE Period: PCSK9 GOFm/ ApoB LOFm (Cohort 2) Group C & Group D
n=10 participants at risk
Subjects with a GOFm in the PCSK9 gene or a LOFm in the Apo B gene (Cohort 2): alirocumab 150 mg SC injection at Week 0 (Day 1), Week 2 (Day 15), Weeks 4, 6 and 10 (matching placebo at Weeks 8, 12 and 14) during the double-blind period (Group C) or at Week 2 (Day 15), Weeks 4, 6, 8 and 12 (matching placebo at Week 0 \[Day 1\], 10 and 14) during the double-blind period (Group D). Afterwards, subjects continued in an OLE period with 150 mg alirocumab SC twice per week (Q2W) for an additional 3 years.
|
|---|---|---|---|---|---|---|
|
General disorders
Chest pain
|
16.7%
1/6 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
9.1%
1/11 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
9.1%
1/11 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
9.1%
1/11 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Gastrointestinal disorders
Salivary gland disorder
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
9.1%
1/11 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
9.1%
1/11 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
Other adverse events
| Measure |
PCSK9 GOFm: Alirocumab From Day 1 (Cohort 1: Group A)
n=6 participants at risk
Participants with a gain-of-function mutation (GOFm) in the PCSK9 gene (Cohort 1: Group A) received 150 mg alirocumab subcutaneously (SC) on days 1, 15, 29, 43, and 71 and matching placebo SC on days 57, 85, and 99 during the double-blind period. Participants who continued in an open-label extension period received 150 mg alirocumab SC twice per week (Q2W) for an additional 3 years.
|
PCSK9 GOFm: Alirocumab From Day 15 (Cohort 1: Group B)
n=7 participants at risk
Participants with a GOFm in PCSK9 gene (Cohort 1: Group B) received 150 mg alirocumab SC on days 15, 29, 43, 57, and 85 and matching placebo SC on days 1, 71, and 99 during the double-blind period. Participants who continued in an open-label extension period received 150 mg alirocumab SC twice per week (Q2W) for an additional 3 years.
|
PCSK9 GOFm/ApoB LOFm: Alirocumab From Day1 (Cohort 2: Group C)
n=5 participants at risk
Participants with a GOFm in the PCSK9 gene or a LOFm in the Apo B gene (Cohort 2: Group C) received 150 mg alirocumab SC on days 1, 15, 29, 43, and 71 and matching placebo SC on days 57, 85, and 99. Participants who continued in an open-label extension period received 150 mg alirocumab SC twice per week (Q2W) for an additional 3 years.
|
PCSK9GOFm/ApoB LOFm: Alirocumab From Day 15(Cohort 2:Group D)
n=5 participants at risk
Subjects with a GOFm in PCSK9 gene or LOFm in Apo B gene (Cohort 2: Group D) received 150 mg alirocumab SC on days 15, 29, 43, 57, and 85 and matching placebo SC on days 1, 71, and 99 during the double-blind period. Afterwards, subjects continued in an open-label extension period with 150 mg alirocumab SC twice per week (Q2W) for an additional 3 years.
|
OLE Period: PCSK9 GOFm (Cohort 1) Group A & Group B
n=11 participants at risk
Subjects with a GOFm in PCSK9 gene (Cohort 1): alirocumab 150 mg subcutaneous (SC) injection at Week 0 (Day 1), Week 2 (Day 15), Weeks 4, 6 and 10 (matching placebo at Week 8, 12 and 14) during the double-blind period (Group A) or at Week 2 (Day 15), Weeks 4, 6, 8 and 12 (matching placebo at Week 0 \[Day 1\], Weeks 10 and 14) during the double-blind period (Group B). Afterwards, subjects continued in an OLE period with 150 mg alirocumab SC twice per week (Q2W) for an additional 3 years.
|
OLE Period: PCSK9 GOFm/ ApoB LOFm (Cohort 2) Group C & Group D
n=10 participants at risk
Subjects with a GOFm in the PCSK9 gene or a LOFm in the Apo B gene (Cohort 2): alirocumab 150 mg SC injection at Week 0 (Day 1), Week 2 (Day 15), Weeks 4, 6 and 10 (matching placebo at Weeks 8, 12 and 14) during the double-blind period (Group C) or at Week 2 (Day 15), Weeks 4, 6, 8 and 12 (matching placebo at Week 0 \[Day 1\], 10 and 14) during the double-blind period (Group D). Afterwards, subjects continued in an OLE period with 150 mg alirocumab SC twice per week (Q2W) for an additional 3 years.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
9.1%
1/11 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
10.0%
1/10 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
14.3%
1/7 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
18.2%
2/11 • Number of events 3 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
20.0%
1/5 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/11 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
10.0%
1/10 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Eye disorders
Dry eye
|
16.7%
1/6 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/11 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Eye disorders
Ocular hyperaemia
|
16.7%
1/6 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/11 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
16.7%
1/6 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
20.0%
1/5 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/11 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
20.0%
1/5 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/11 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/11 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Gastrointestinal disorders
Haemorrhoids
|
16.7%
1/6 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/11 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/11 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
General disorders
Chest pain
|
16.7%
1/6 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
20.0%
1/5 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
9.1%
1/11 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
20.0%
1/5 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/11 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Infections and infestations
Gastroenteritis
|
33.3%
2/6 • Number of events 2 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
14.3%
1/7 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
20.0%
1/5 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/11 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
10.0%
1/10 • Number of events 2 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Infections and infestations
Influenza
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
20.0%
1/5 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/11 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Infections and infestations
Lower respiratory tract infection
|
16.7%
1/6 • Number of events 2 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
20.0%
1/5 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
20.0%
1/5 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/11 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
10.0%
1/10 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
14.3%
1/7 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
9.1%
1/11 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
14.3%
1/7 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
20.0%
1/5 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
9.1%
1/11 • Number of events 4 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
10.0%
1/10 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
20.0%
1/5 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/11 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Infections and infestations
Rhinitis
|
16.7%
1/6 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
18.2%
2/11 • Number of events 2 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Infections and infestations
Upper respiratory tract infection
|
16.7%
1/6 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
14.3%
1/7 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
9.1%
1/11 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
20.0%
2/10 • Number of events 2 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
20.0%
1/5 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/11 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
20.0%
1/5 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/11 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
1/6 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
18.2%
2/11 • Number of events 2 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
20.0%
1/5 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/11 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
14.3%
1/7 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
9.1%
1/11 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
1/6 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/11 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
28.6%
2/7 • Number of events 3 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
20.0%
1/5 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/11 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Nervous system disorders
Migraine
|
16.7%
1/6 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/11 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
14.3%
1/7 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
9.1%
1/11 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Nervous system disorders
Paraesthesia
|
16.7%
1/6 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
14.3%
1/7 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/11 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
14.3%
1/7 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
18.2%
2/11 • Number of events 2 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Nervous system disorders
Sciatica
|
16.7%
1/6 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/11 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
16.7%
1/6 • Number of events 2 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
14.3%
1/7 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/11 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
14.3%
1/7 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/11 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
14.3%
1/7 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
20.0%
1/5 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
20.0%
1/5 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
9.1%
1/11 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Vascular disorders
Raynaud's phenomenon
|
16.7%
1/6 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/11 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
20.0%
1/5 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/11 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
10.0%
1/10 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Ear and labyrinth disorders
Ear pruritus
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
14.3%
1/7 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/11 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
16.7%
1/6 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/11 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
33.3%
2/6 • Number of events 3 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
14.3%
1/7 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
40.0%
2/5 • Number of events 4 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
20.0%
1/5 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
36.4%
4/11 • Number of events 6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
20.0%
2/10 • Number of events 2 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
9.1%
1/11 • Number of events 2 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Cardiac disorders
Prinzmetal angina
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
9.1%
1/11 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Endocrine disorders
Thyroid mass
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
9.1%
1/11 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
9.1%
1/11 • Number of events 2 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Gastrointestinal disorders
Dyspesia
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
9.1%
1/11 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Gastrointestinal disorders
Functional gastrointestinal disorder
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
9.1%
1/11 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
9.1%
1/11 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/11 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
10.0%
1/10 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
General disorders
Asthenia
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
18.2%
2/11 • Number of events 3 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
General disorders
Inflammation
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
9.1%
1/11 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
General disorders
Oedema peripheral
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
9.1%
1/11 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
9.1%
1/11 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
9.1%
1/11 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Infections and infestations
Cystitis
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
9.1%
1/11 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
9.1%
1/11 • Number of events 2 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Infections and infestations
Ear infection
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
9.1%
1/11 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
9.1%
1/11 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Infections and infestations
Infectious mononucleosis
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/11 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
10.0%
1/10 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/11 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
10.0%
1/10 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Infections and infestations
Localised infection
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/11 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
10.0%
1/10 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
9.1%
1/11 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
9.1%
1/11 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Infections and infestations
Sialoadenitis
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
9.1%
1/11 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
9.1%
1/11 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
9.1%
1/11 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
18.2%
2/11 • Number of events 2 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
9.1%
1/11 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Injury, poisoning and procedural complications
Cardiac procedure complication
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
9.1%
1/11 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/11 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
10.0%
1/10 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
9.1%
1/11 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
9.1%
1/11 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
9.1%
1/11 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Investigations
Cardiac murmur
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
9.1%
1/11 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Investigations
Nitrite urine present
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
9.1%
1/11 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Investigations
White blood cells urine positive
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
9.1%
1/11 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
9.1%
1/11 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
9.1%
1/11 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Metabolism and nutrition disorders
Vitamin B complex deficiency
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
9.1%
1/11 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
9.1%
1/11 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
9.1%
1/11 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
9.1%
1/11 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
9.1%
1/11 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
9.1%
1/11 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour benign
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
9.1%
1/11 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
9.1%
1/11 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
9.1%
1/11 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Nervous system disorders
Diabetic neuropathy
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
9.1%
1/11 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
9.1%
1/11 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
9.1%
1/11 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
9.1%
1/11 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
9.1%
1/11 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
9.1%
1/11 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Skin and subcutaneous tissue disorders
Peau d'orange
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
9.1%
1/11 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Nervous system disorders
Syncope
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
9.1%
1/11 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/11 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
10.0%
1/10 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
9.1%
1/11 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
10.0%
1/10 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
9.1%
1/11 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
9.1%
1/11 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Vascular disorders
Diabetic vascular disorder
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
9.1%
1/11 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/6 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/7 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/5 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
9.1%
1/11 • Number of events 1 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
0.00%
0/10 • From the screening visit after the last alirocumab injection in the open-label period + 70 days through the end of study
Observation periods for safety analyses: Pretreatment: screening to before 1st injection of alirocumab; Double-blind (DB) treatment-emergent (TE): after 1st through last in DB+70 days; Interim: after last in DB+70 days prior to 1st in open-label (OL). OL TE: after 1st through last in OL+70 days. Post: after last in OL+70 days through end of study.
|
Additional Information
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