Trial Outcomes & Findings for Study of Alirocumab (REGN727/SAR236553) in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) Undergoing Low-density Lipoprotein (LDL) Apheresis Therapy (NCT NCT02326220)
NCT ID: NCT02326220
Last Updated: 2020-05-01
Results Overview
Rate of apheresis treatments were normalized by the number of planned apheresis treatments according to each participant's established schedule at screening, week -10 to week -2. The normalized rate of apheresis was defined for each participant as the number of actual apheresis treatments received from week 7 to week 18 divided by the number of planned apheresis treatments per randomization strata at baseline (6 for Q2W and 12 for QW).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
62 participants
Primary outcome timeframe
Week 7 to Week 18 (before start of open-label treatment)
Results posted on
2020-05-01
Participant Flow
The study was conducted in Germany and the United States between 09 Mar 2015 and 20 Apr 2016. A total of 76 participants were screened, of which 62 were enrolled and randomized in the study.
Randomization was stratified according to the frequency of the apheresis procedure (every 7 or 14 days) and lipoprotein (a) (Lp \[a\]) levels (normal or elevated). Assignment to treatment arms was done using an Interactive Voice/Web Response System in 1:2 ratio to placebo or alirocumab 150 mg Q2W.
Participant milestones
| Measure |
Placebo Q2W (Double Blind Period)
Placebo (for alirocumab) subcutaneous (SC) injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment. (Participants undergoing LDL apheresis therapy every 1 or 2 weeks were enrolled in this study while maintaining background lipid modifying therapy (LMT) treatment throughout the study. All participants were being treated with the maximally tolerated clinically-relevant LMT).
|
Alirocumab 150 mg Q2W (Double Blind Period)
Alirocumab 150 mg SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment. (Participants undergoing LDL apheresis therapy every 1 or 2 weeks were enrolled in this study while maintaining background lipid modifying therapy (LMT) treatment throughout the study. All participants were being treated with the maximally tolerated clinically-relevant LMT).
|
Alirocumab 150 Q2W (Open Label Treatment Period)
Alirocumab 150 mg SC injection Q2W starting from Week 18 up to Week 76 or until alirocumab became commercially available in the subject's country, whichever occurred first. Apheresis treatment not required in the open-label treatment period and could be stopped or continued at the investigator's discretion. (All participants were being treated with the maximally tolerated clinically-relevant LMT.)
|
|---|---|---|---|
|
Double-blind Treatment Period
STARTED
|
21
|
41
|
0
|
|
Double-blind Treatment Period
COMPLETED
|
20
|
37
|
0
|
|
Double-blind Treatment Period
NOT COMPLETED
|
1
|
4
|
0
|
|
Open-label Treatment Period
STARTED
|
0
|
0
|
29
|
|
Open-label Treatment Period
COMPLETED
|
0
|
0
|
27
|
|
Open-label Treatment Period
NOT COMPLETED
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
Placebo Q2W (Double Blind Period)
Placebo (for alirocumab) subcutaneous (SC) injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment. (Participants undergoing LDL apheresis therapy every 1 or 2 weeks were enrolled in this study while maintaining background lipid modifying therapy (LMT) treatment throughout the study. All participants were being treated with the maximally tolerated clinically-relevant LMT).
|
Alirocumab 150 mg Q2W (Double Blind Period)
Alirocumab 150 mg SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment. (Participants undergoing LDL apheresis therapy every 1 or 2 weeks were enrolled in this study while maintaining background lipid modifying therapy (LMT) treatment throughout the study. All participants were being treated with the maximally tolerated clinically-relevant LMT).
|
Alirocumab 150 Q2W (Open Label Treatment Period)
Alirocumab 150 mg SC injection Q2W starting from Week 18 up to Week 76 or until alirocumab became commercially available in the subject's country, whichever occurred first. Apheresis treatment not required in the open-label treatment period and could be stopped or continued at the investigator's discretion. (All participants were being treated with the maximally tolerated clinically-relevant LMT.)
|
|---|---|---|---|
|
Double-blind Treatment Period
Adverse Event
|
1
|
2
|
0
|
|
Double-blind Treatment Period
Protocol Violation
|
0
|
1
|
0
|
|
Double-blind Treatment Period
Withdrawal by Subject
|
0
|
1
|
0
|
|
Open-label Treatment Period
Withdrawal by Subject
|
0
|
0
|
1
|
|
Open-label Treatment Period
Lost to Follow-up
|
0
|
0
|
1
|
Baseline Characteristics
Study of Alirocumab (REGN727/SAR236553) in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) Undergoing Low-density Lipoprotein (LDL) Apheresis Therapy
Baseline characteristics by cohort
| Measure |
Placebo Q2W (Double Blind Period)
n=21 Participants
Placebo (for alirocumab) SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment. (Participants undergoing LDL apheresis therapy every 1 or 2 weeks were enrolled in this study while maintaining background lipid modifying therapy (LMT) treatment throughout the study. All participants were being treated with the maximally tolerated clinically-relevant LMT).
|
Alirocumab 150 mg Q2W (Double Blind Period)
n=41 Participants
Alirocumab 150 mg SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment. (Participants undergoing LDL apheresis therapy every 1 or 2 weeks were enrolled in this study while maintaining background lipid modifying therapy (LMT) treatment throughout the study. All participants were being treated with the maximally tolerated clinically-relevant LMT).
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
59.5 years
STANDARD_DEVIATION 9.2 • n=7 Participants
|
58.7 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Frequency in which participants are undergoing LDL apheresis
Every week
|
9 Treatments
n=5 Participants
|
18 Treatments
n=7 Participants
|
27 Treatments
n=5 Participants
|
|
Frequency in which participants are undergoing LDL apheresis
Every 2 weeks
|
12 Treatments
n=5 Participants
|
23 Treatments
n=7 Participants
|
35 Treatments
n=5 Participants
|
|
Calculated low-density lipoprotein cholesterol (LDL-C)
|
191.6 mg/dL
STANDARD_DEVIATION 68.9 • n=5 Participants
|
175.1 mg/dL
STANDARD_DEVIATION 54.6 • n=7 Participants
|
180.7 mg/dL
STANDARD_DEVIATION 59.7 • n=5 Participants
|
|
Measured LDL-C
|
195.0 mg/dL
STANDARD_DEVIATION 66.9 • n=5 Participants
|
174.0 mg/dL
STANDARD_DEVIATION 51.4 • n=7 Participants
|
181.1 mg/dL
STANDARD_DEVIATION 57.4 • n=5 Participants
|
|
Non-high-density lipoprotein cholesterol (HDL-C)
|
224.5 mg/dL
STANDARD_DEVIATION 68.0 • n=5 Participants
|
210.3 mg/dL
STANDARD_DEVIATION 62.8 • n=7 Participants
|
215.1 mg/dL
STANDARD_DEVIATION 64.4 • n=5 Participants
|
|
Total-cholesterol (Total-C)
|
272.3 mg/dL
STANDARD_DEVIATION 73.6 • n=5 Participants
|
256.9 mg/dL
STANDARD_DEVIATION 60.6 • n=7 Participants
|
262.1 mg/dL
STANDARD_DEVIATION 65.1 • n=5 Participants
|
|
High-density lipoprotein cholesterol (HDL-C)
|
47.8 mg/dL
STANDARD_DEVIATION 17.3 • n=5 Participants
|
46.6 mg/dL
STANDARD_DEVIATION 16.2 • n=7 Participants
|
47.0 mg/dL
STANDARD_DEVIATION 16.4 • n=5 Participants
|
|
Triglycerides (TGs)
|
164.4 mg/dL
STANDARD_DEVIATION 61.4 • n=5 Participants
|
176.0 mg/dL
STANDARD_DEVIATION 87.2 • n=7 Participants
|
172.1 mg/dL
STANDARD_DEVIATION 79.0 • n=5 Participants
|
|
Lipoprotein a [Lp(a)]
|
45.7 mg/dL
STANDARD_DEVIATION 49.5 • n=5 Participants
|
43.0 mg/dL
STANDARD_DEVIATION 54.5 • n=7 Participants
|
43.9 mg/dL
STANDARD_DEVIATION 52.4 • n=5 Participants
|
|
Apolipoprotein B (Apo-B)
|
145.8 mg/dL
STANDARD_DEVIATION 34.0 • n=5 Participants
|
135.2 mg/dL
STANDARD_DEVIATION 36.4 • n=7 Participants
|
138.8 mg/dL
STANDARD_DEVIATION 35.7 • n=5 Participants
|
|
Apolipoprotein A1 (Apo-A1)
|
145.8 mg/dL
STANDARD_DEVIATION 32.5 • n=5 Participants
|
140.1 mg/dL
STANDARD_DEVIATION 25.5 • n=7 Participants
|
142.1 mg/dL
STANDARD_DEVIATION 27.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: Week 7 to Week 18 (before start of open-label treatment)Population: Primary intent-to-treat (ITT) population defined as all randomized participants and were analyzed according to the treatment group allocated by randomization.
Rate of apheresis treatments were normalized by the number of planned apheresis treatments according to each participant's established schedule at screening, week -10 to week -2. The normalized rate of apheresis was defined for each participant as the number of actual apheresis treatments received from week 7 to week 18 divided by the number of planned apheresis treatments per randomization strata at baseline (6 for Q2W and 12 for QW).
Outcome measures
| Measure |
Placebo Q2W (Double Blind Period)
n=21 Participants
Placebo (for alirocumab) subcutaneous (SC) injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment.
|
Alirocumab 150 mg Q2W (Double Blind Period)
n=41 Participants
Alirocumab 150 mg SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment.
|
|---|---|---|
|
Change in Standardized Rate of Apheresis Treatments From Week 7 to Week 18
|
0.806 Treatments
Standard Deviation 0.191
|
0.128 Treatments
Standard Deviation 0.242
|
SECONDARY outcome
Timeframe: Baseline and at Week 6Population: Analysis was performed on ITT population that included all randomized particpants with baseline and at least one post-baseline pre-apheresis calculated LDL-C value up to week 6, analyzed according to the treatment group allocated by randomization.
Adjusted Least-squares (LS) means and standard errors at Week 6 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 2 to Week 18 regardless of status on or off-treatment were used in the model (ITT analysis).
Outcome measures
| Measure |
Placebo Q2W (Double Blind Period)
n=21 Participants
Placebo (for alirocumab) subcutaneous (SC) injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment.
|
Alirocumab 150 mg Q2W (Double Blind Period)
n=41 Participants
Alirocumab 150 mg SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment.
|
|---|---|---|
|
Percent Change From Baseline in Calculated LDL-C (Pre-apheresis) at Week 6
|
1.6 percent change in mmol/L
Standard Error 3.1
|
-53.7 percent change in mmol/L
Standard Error 2.3
|
SECONDARY outcome
Timeframe: Week 15 up to Week 18 (before the start of open-label treatment dose)Population: Analysis was performed on ITT population.
Rate of apheresis treatments were normalized by the rate by the number of actual apheresis treatments according to received from week 15 to week 18 divided by the planned apheresis treatments per randomization strata at baseline (2 for Q2W and 4 for QW). Only legitimate apheresis treatment skipping per point-of-care LDL-C value is counted as "apheresis not occurred". Missing apheresis treatment information (any reason) from week 7 to week 18 is assigned an outcome of the apheresis treatment occurred at the visit (i.e. impute 1 apheresis treatment for that visit).
Outcome measures
| Measure |
Placebo Q2W (Double Blind Period)
n=21 Participants
Placebo (for alirocumab) subcutaneous (SC) injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment.
|
Alirocumab 150 mg Q2W (Double Blind Period)
n=41 Participants
Alirocumab 150 mg SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment.
|
|---|---|---|
|
Change in Standardized Rate of Apheresis Treatments From Week 15 to Week 18
|
0.774 Treatments
Standard Deviation 0.315
|
0.165 Treatments
Standard Deviation 0.334
|
SECONDARY outcome
Timeframe: From Baseline to Week 6Population: Analysis was performed on ITT population.
Adjusted LS means and standard errors at Week 6 were obtained from MMRM to account for missing data. All available post-baseline data from Week 2 (pre-apheresis) to Week 18 (pre-apheresis) regardless of status on- or off-treatment were used in the model (ITT analysis).
Outcome measures
| Measure |
Placebo Q2W (Double Blind Period)
n=21 Participants
Placebo (for alirocumab) subcutaneous (SC) injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment.
|
Alirocumab 150 mg Q2W (Double Blind Period)
n=41 Participants
Alirocumab 150 mg SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment.
|
|---|---|---|
|
Percent Change From Baseline in Apolipoprotein B (Apo B) (Pre-apheresis) to Week 6
|
1.2 Percent change
Standard Error 3
|
-42.8 Percent change
Standard Error 2.1
|
SECONDARY outcome
Timeframe: From Baseline to Week 6Population: Analysis was performed on ITT population.
Adjusted LS means and standard errors at Week 6 were obtained from MMRM to account for missing data. All available post-baseline data from Week 2 (pre-apheresis) to Week 18 (pre-apheresis) regardless of status on- or off-treatment were used in the model (ITT analysis).
Outcome measures
| Measure |
Placebo Q2W (Double Blind Period)
n=21 Participants
Placebo (for alirocumab) subcutaneous (SC) injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment.
|
Alirocumab 150 mg Q2W (Double Blind Period)
n=41 Participants
Alirocumab 150 mg SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment.
|
|---|---|---|
|
Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) (Pre-apheresis) to Week 6
|
2.8 Percent change
Standard Error 2.9
|
-47.1 Percent change
Standard Error 2.1
|
SECONDARY outcome
Timeframe: From Baseline to Week 6Population: Analysis was performed on ITT population.
Adjusted LS means and standard errors at Week 6 were obtained from MMRM to account for missing data. All available post-baseline data from Week 2 (pre-apheresis) to Week 18 (pre-apheresis) regardless of status on- or off-treatment were used in the model (ITT analysis).
Outcome measures
| Measure |
Placebo Q2W (Double Blind Period)
n=21 Participants
Placebo (for alirocumab) subcutaneous (SC) injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment.
|
Alirocumab 150 mg Q2W (Double Blind Period)
n=41 Participants
Alirocumab 150 mg SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment.
|
|---|---|---|
|
Percent Change From Baseline in Total Cholesterol (Pre-apheresis) to Week 6
|
3.1 Percent change
Standard Error 2.5
|
-36.4 Percent change
Standard Error 1.8
|
SECONDARY outcome
Timeframe: From Baseline to Week 6Population: Analysis was performed on ITT population.
Adjusted LS means and standard errors at Week 6 were obtained from MMRM to account for missing data. All available post-baseline data from Week 2 (pre-apheresis) to Week 18 (pre-apheresis) regardless of status on- or off-treatment were used in the model (ITT analysis).
Outcome measures
| Measure |
Placebo Q2W (Double Blind Period)
n=21 Participants
Placebo (for alirocumab) subcutaneous (SC) injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment.
|
Alirocumab 150 mg Q2W (Double Blind Period)
n=41 Participants
Alirocumab 150 mg SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment.
|
|---|---|---|
|
Percent Change From Baseline in Apolipoprotein A (Apo A1) (Pre-apheresis) to Week 6
|
0 Percent change
Standard Error 3.3
|
4.2 Percent change
Standard Error 2.4
|
SECONDARY outcome
Timeframe: From Baseline to Week 6Population: Analysis was performed on ITT population.
Percentage of participants at Week 6 was obtained from a last observation carried forward (LOCF) model for handling of missing data. All available post-baseline data regardless of status on- or off-treatment were used in the model (ITT analysis).
Outcome measures
| Measure |
Placebo Q2W (Double Blind Period)
n=21 Participants
Placebo (for alirocumab) subcutaneous (SC) injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment.
|
Alirocumab 150 mg Q2W (Double Blind Period)
n=41 Participants
Alirocumab 150 mg SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment.
|
|---|---|---|
|
Percentage of Participants With At Least (>=) 30% Reduction in Calculated LDL-C (Pre-apheresis) at Week 6
|
4.8 percentage of participants
|
95.1 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline to Week 6Population: Analysis was performed on ITT population.
Percentage of participants at Week 6 was obtained from LOCF model for handling of missing data. All available post-baseline data regardless of status on- or off-treatment were used in the model (ITT analysis).
Outcome measures
| Measure |
Placebo Q2W (Double Blind Period)
n=21 Participants
Placebo (for alirocumab) subcutaneous (SC) injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment.
|
Alirocumab 150 mg Q2W (Double Blind Period)
n=41 Participants
Alirocumab 150 mg SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment.
|
|---|---|---|
|
Percentage of Participants With At Least (>=) 50% Reduction in Calculated LDL-C (Pre-apheresis) at Week 6
|
0 percentage of participants
|
63.4 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline to Week 18Population: Analysis was performed on ITT population.
Adjusted LS means and standard errors at Week 18 were obtained from MMRM to account for missing data. All available post-baseline data from Week 2 (pre-apheresis) to Week 18 (pre-apheresis) regardless of status on- or off-treatment were used in the model (ITT analysis).
Outcome measures
| Measure |
Placebo Q2W (Double Blind Period)
n=21 Participants
Placebo (for alirocumab) subcutaneous (SC) injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment.
|
Alirocumab 150 mg Q2W (Double Blind Period)
n=41 Participants
Alirocumab 150 mg SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment.
|
|---|---|---|
|
Percent Change From Baseline in Calculated LDL-C (Pre-Apheresis) to Week 18
|
4 Percent change
Standard Error 6.2
|
-42.3 Percent change
Standard Error 4.5
|
SECONDARY outcome
Timeframe: From Baseline to Week 18Population: Analysis was performed on ITT population.
Adjusted LS means and standard errors at Week 18 were obtained from MMRM to account for missing data. All available post-baseline data from Week 2 (pre-apheresis) to Week 18 (pre-apheresis) regardless of status on- or off-treatment were used in the model (ITT analysis).
Outcome measures
| Measure |
Placebo Q2W (Double Blind Period)
n=21 Participants
Placebo (for alirocumab) subcutaneous (SC) injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment.
|
Alirocumab 150 mg Q2W (Double Blind Period)
n=41 Participants
Alirocumab 150 mg SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment.
|
|---|---|---|
|
Percent Change From Baseline in Apolipoprotein B (Apo B) (Pre-apheresis) to Week 18
|
1.7 percent change
Standard Error 4.8
|
-33.8 percent change
Standard Error 3.5
|
SECONDARY outcome
Timeframe: From Baseline to Week 18Population: Analysis was performed on ITT population.
Adjusted LS means and standard errors at Week 18 were obtained from MMRM to account for missing data. All available post-baseline data from Week 2 (pre-apheresis) to Week 18 (pre-apheresis) regardless of status on- or off-treatment were used in the model (ITT analysis).
Outcome measures
| Measure |
Placebo Q2W (Double Blind Period)
n=21 Participants
Placebo (for alirocumab) subcutaneous (SC) injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment.
|
Alirocumab 150 mg Q2W (Double Blind Period)
n=41 Participants
Alirocumab 150 mg SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment.
|
|---|---|---|
|
Percent Change From Baseline in Non-HDL-C (Pre-apheresis) to Week 18
|
4.7 Percent change
Standard Error 5.6
|
-35.7 Percent change
Standard Error 4.1
|
SECONDARY outcome
Timeframe: From Baseline to Week 18Population: Analysis was performed on ITT population.
Adjusted LS means and standard errors at Week 18 were obtained from MMRM to account for missing data. All available post-baseline data from Week 2 (pre-apheresis) to Week 18 (pre-apheresis) regardless of status on- or off-treatment were used in the model (ITT analysis).
Outcome measures
| Measure |
Placebo Q2W (Double Blind Period)
n=21 Participants
Placebo (for alirocumab) subcutaneous (SC) injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment.
|
Alirocumab 150 mg Q2W (Double Blind Period)
n=41 Participants
Alirocumab 150 mg SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment.
|
|---|---|---|
|
Percent Change From Baseline in Total Cholesterol (Pre-apheresis) to Week 18
|
4.7 Percent change
Standard Error 4.7
|
-27.1 Percent change
Standard Error 3.4
|
SECONDARY outcome
Timeframe: From Baseline to Week 18Population: Analysis was performed on ITT population.
Adjusted LS means and standard errors at Week 18 were obtained from MMRM to account for missing data. All available post-baseline data from Week 2 (pre-apheresis) to Week 18 (pre-apheresis) regardless of status on- or off-treatment were used in the model (ITT analysis).
Outcome measures
| Measure |
Placebo Q2W (Double Blind Period)
n=21 Participants
Placebo (for alirocumab) subcutaneous (SC) injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment.
|
Alirocumab 150 mg Q2W (Double Blind Period)
n=41 Participants
Alirocumab 150 mg SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment.
|
|---|---|---|
|
Percent Change From Baseline in Apo A1 (Pre-apheresis) to Week 18
|
-0.7 Percent change
Standard Error 3.4
|
7.8 Percent change
Standard Error 2.4
|
SECONDARY outcome
Timeframe: From Baseline to Week 18Population: Analysis was performed on ITT population.
Percentage of participants at Week 18 was obtained from LOCF model for handling of missing data. All available post-baseline data regardless of status on- or off-treatment were used in the model (ITT analysis).
Outcome measures
| Measure |
Placebo Q2W (Double Blind Period)
n=21 Participants
Placebo (for alirocumab) subcutaneous (SC) injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment.
|
Alirocumab 150 mg Q2W (Double Blind Period)
n=41 Participants
Alirocumab 150 mg SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment.
|
|---|---|---|
|
Percentage of Participants With At Least (>=) 30% Reduction in Calculated LDL-C (Pre-apheresis) at Week 18
|
0 percentage of participants
|
65.9 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline to Week 18Population: Analysis was performed on ITT population.
Percentage of participants at Week 18 was obtained from LOCF model for handling of missing data. All available post-baseline data regardless of status on- or off-treatment were used in the model (ITT analysis).
Outcome measures
| Measure |
Placebo Q2W (Double Blind Period)
n=21 Participants
Placebo (for alirocumab) subcutaneous (SC) injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment.
|
Alirocumab 150 mg Q2W (Double Blind Period)
n=41 Participants
Alirocumab 150 mg SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment.
|
|---|---|---|
|
Percentage of Participants With At Least (>=) 50% Reduction in Calculated LDL-C (Pre-apheresis) at Week 18
|
0 percentage of participants
|
43.9 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline to Week 18Population: Analysis was performed on Well-Being analysis set included all randomized and treated participants with complete baseline and complete post-baseline evaluations of the 22-question well-being questionnaire.
The W-BQ22 (well-being) questionnaire was a standardized and generic instrument used for measuring the impact of hypercholesterolemia and treatment on well-being of participants. The general well-being score was calculated as the sum of 22 questions in the W-BQ22 questionnaire (each question scored from 0 to 3 \[0 = not at all and 3 = all the time\]). Total score for 22 questions range from 0 to 66 \[0 = worst condition and 66 = best well-being condition).
Outcome measures
| Measure |
Placebo Q2W (Double Blind Period)
n=19 Participants
Placebo (for alirocumab) subcutaneous (SC) injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment.
|
Alirocumab 150 mg Q2W (Double Blind Period)
n=38 Participants
Alirocumab 150 mg SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment.
|
|---|---|---|
|
Change From Baseline in W-BQ22 (Well-being Questionnaire) Index Score at Week 18
|
-1.43 scores on a scale
Standard Error 1.441
|
0.91 scores on a scale
Standard Error 1.04
|
SECONDARY outcome
Timeframe: From Baseline to Week 6Population: Analysis was performed on ITT population.
Adjusted means and standard errors at Week 6 from a multiple imputation approach followed by robust regression model including all available post-baseline data from Week 2 (pre-apheresis) to Week 18 (pre-apheresis) regardless of status on- or off-treatment were used in the model (ITT analysis).
Outcome measures
| Measure |
Placebo Q2W (Double Blind Period)
n=21 Participants
Placebo (for alirocumab) subcutaneous (SC) injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment.
|
Alirocumab 150 mg Q2W (Double Blind Period)
n=41 Participants
Alirocumab 150 mg SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment.
|
|---|---|---|
|
Percent Change From Baseline in Lipoprotein (a) (Lp [a]) (Pre-apheresis) to Week 6
|
-4 percent change
Standard Error 5.1
|
-18.1 percent change
Standard Error 3.7
|
SECONDARY outcome
Timeframe: From Baseline to Week 6Population: Analysis was performed on ITT population.
Adjusted LS means and standard errors at Week 6 were obtained from MMRM to account for missing data. All available post-baseline data from Week 2 (pre-apheresis) to Week 18 (pre-apheresis) regardless of status on- or off-treatment were used in the model (ITT analysis).
Outcome measures
| Measure |
Placebo Q2W (Double Blind Period)
n=21 Participants
Placebo (for alirocumab) subcutaneous (SC) injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment.
|
Alirocumab 150 mg Q2W (Double Blind Period)
n=41 Participants
Alirocumab 150 mg SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment.
|
|---|---|---|
|
Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) (Pre-apheresis) to Week 6
|
4 percent change
Standard Error 3.4
|
9.3 percent change
Standard Error 2.4
|
SECONDARY outcome
Timeframe: From Baseline to Week 6Population: Analysis was performed on ITT population.
Adjusted means and standard errors at Week 6 from a multiple imputation approach followed by robust regression model including all available post-baseline data from Week 2 (pre-apheresis) to Week 18 (pre-apheresis) regardless of status on- or off-treatment were used in the model (ITT analysis).
Outcome measures
| Measure |
Placebo Q2W (Double Blind Period)
n=21 Participants
Placebo (for alirocumab) subcutaneous (SC) injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment.
|
Alirocumab 150 mg Q2W (Double Blind Period)
n=41 Participants
Alirocumab 150 mg SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment.
|
|---|---|---|
|
Percent Change From Baseline in Triglyceride (TG) Levels (Pre-apheresis) to Week 6
|
3 percent change
Standard Error 5.6
|
-12.9 percent change
Standard Error 4
|
SECONDARY outcome
Timeframe: From Baseline to Week 18Population: Analysis was performed on ITT population.
Adjusted means and standard errors at Week 18 from a multiple imputation approach followed by robust regression model including all available post-baseline data from Week 2 (pre-apheresis) to Week 18 (pre-apheresis) regardless of status on- or off-treatment were used in the model (ITT analysis).
Outcome measures
| Measure |
Placebo Q2W (Double Blind Period)
n=21 Participants
Placebo (for alirocumab) subcutaneous (SC) injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment.
|
Alirocumab 150 mg Q2W (Double Blind Period)
n=41 Participants
Alirocumab 150 mg SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment.
|
|---|---|---|
|
Percent Change From Baseline in Lp (a) (Pre-apheresis) to Week 18
|
-1.2 Percent change
Standard Error 8
|
-6.1 Percent change
Standard Error 5.9
|
SECONDARY outcome
Timeframe: From Baseline to Week 18Population: Analysis was performed on ITT population.
Adjusted LS means and standard errors at Week 18 were obtained from MMRM to account for missing data. All available post-baseline data from Week 2 (pre-apheresis) to Week 18 (pre-apheresis) regardless of status on- or off-treatment were used in the model (ITT analysis).
Outcome measures
| Measure |
Placebo Q2W (Double Blind Period)
n=21 Participants
Placebo (for alirocumab) subcutaneous (SC) injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment.
|
Alirocumab 150 mg Q2W (Double Blind Period)
n=41 Participants
Alirocumab 150 mg SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment.
|
|---|---|---|
|
Percent Change From Baseline in HDL-C (Pre-apheresis) to Week 18
|
2.4 Percent change
Standard Error 5
|
10.9 Percent change
Standard Error 3.6
|
SECONDARY outcome
Timeframe: From Baseline to Week 18Population: Analysis was performed on ITT population.
Adjusted means and standard errors at Week 18 from a multiple imputation approach followed by robust regression model including all available post-baseline data from Week 2 (pre-apheresis) to Week 18 (pre-apheresis) regardless of status on- or off-treatment were used in the model (ITT analysis).
Outcome measures
| Measure |
Placebo Q2W (Double Blind Period)
n=21 Participants
Placebo (for alirocumab) subcutaneous (SC) injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment.
|
Alirocumab 150 mg Q2W (Double Blind Period)
n=41 Participants
Alirocumab 150 mg SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment.
|
|---|---|---|
|
Percent Change From Baseline in TG Levels (Pre-apheresis) to Week 18
|
4.1 Percent change
Standard Error 7.9
|
-2.4 Percent change
Standard Error 5.8
|
Adverse Events
Placebo Q2W (Double Blind Period)
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Alirocumab 150 Q2W (Double Blind Period)
Serious events: 4 serious events
Other events: 22 other events
Deaths: 0 deaths
Alirocumab 150 Q2W (Open Label Treatment Period)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo Q2W (Double Blind Period)
n=21 participants at risk
Placebo (for alirocumab) subcutaneous (SC) injection Q2W up to Week 16 (mean exposure of 17 weeks).
|
Alirocumab 150 Q2W (Double Blind Period)
n=41 participants at risk
Alirocumab 150 mg SC injection Q2W up to Week 16 (mean exposure of 17 weeks).
|
Alirocumab 150 Q2W (Open Label Treatment Period)
n=29 participants at risk
Alirocumab 150 mg SC injection Q2W from Week 18 (mean exposure of 17 weeks).
|
|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/21 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
4.9%
2/41 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
0.00%
0/29 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
|
Cardiac disorders
Angina pectoris
|
4.8%
1/21 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
0.00%
0/41 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
0.00%
0/29 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/21 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
2.4%
1/41 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
0.00%
0/29 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/21 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
2.4%
1/41 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
0.00%
0/29 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/21 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
2.4%
1/41 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
0.00%
0/29 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/21 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
0.00%
0/41 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
3.4%
1/29 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
|
Cardiac disorders
Sinus bradycardia
|
4.8%
1/21 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
0.00%
0/41 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
0.00%
0/29 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/21 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
2.4%
1/41 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
0.00%
0/29 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
|
Infections and infestations
Sepsis
|
0.00%
0/21 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
2.4%
1/41 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
0.00%
0/29 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.00%
0/21 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
2.4%
1/41 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
0.00%
0/29 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
|
Injury, poisoning and procedural complications
Peripheral artery restenosis
|
0.00%
0/21 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
0.00%
0/41 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
3.4%
1/29 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
|
Injury, poisoning and procedural complications
Shunt thrombosis
|
4.8%
1/21 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
0.00%
0/41 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
0.00%
0/29 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
0.00%
0/21 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
2.4%
1/41 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
0.00%
0/29 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/21 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
2.4%
1/41 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
0.00%
0/29 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
Other adverse events
| Measure |
Placebo Q2W (Double Blind Period)
n=21 participants at risk
Placebo (for alirocumab) subcutaneous (SC) injection Q2W up to Week 16 (mean exposure of 17 weeks).
|
Alirocumab 150 Q2W (Double Blind Period)
n=41 participants at risk
Alirocumab 150 mg SC injection Q2W up to Week 16 (mean exposure of 17 weeks).
|
Alirocumab 150 Q2W (Open Label Treatment Period)
n=29 participants at risk
Alirocumab 150 mg SC injection Q2W from Week 18 (mean exposure of 17 weeks).
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/21 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
2.4%
1/41 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
6.9%
2/29 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
|
Cardiac disorders
Palpitations
|
9.5%
2/21 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
0.00%
0/41 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
0.00%
0/29 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/21 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
9.8%
4/41 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
0.00%
0/29 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
|
Gastrointestinal disorders
Nausea
|
14.3%
3/21 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
4.9%
2/41 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
0.00%
0/29 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
|
General disorders
Fatigue
|
9.5%
2/21 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
14.6%
6/41 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
0.00%
0/29 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
|
Infections and infestations
Nasopharyngitis
|
9.5%
2/21 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
9.8%
4/41 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
3.4%
1/29 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
|
Infections and infestations
Upper respiratory tract infection
|
19.0%
4/21 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
7.3%
3/41 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
0.00%
0/29 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.5%
2/21 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
7.3%
3/41 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
0.00%
0/29 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.5%
2/21 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
4.9%
2/41 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
0.00%
0/29 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.8%
1/21 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
12.2%
5/41 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
0.00%
0/29 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
|
Nervous system disorders
Headache
|
9.5%
2/21 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
7.3%
3/41 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
0.00%
0/29 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final study end visit (maximum duration: 46 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period'(double blind treatment-emergent period: time from first dose of study drug to last double-blind dose+70 days, prior to first open-label dose of study drug; open-label treatment emergent period: time from first open-label dose of study drug to last dose+70 days).
|
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