Study of the Safety and Efficacy of REGN727/SAR236553 in... | NCT01266876

Name	Class
Sanofi	INDUSTRY

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Drug: Placebo
Alirocumab 150 mg Q4W	Experimental	Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Drug: Alirocumab
Alirocumab 200 mg Q4W	Experimental	Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Drug: Alirocumab
Alirocumab 300 mg Q4W	Experimental	Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Drug: Alirocumab
Alirocumab 150 mg Q2W	Experimental	Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Drug: Alirocumab

Name	Type	Description	Arm Group Labels	Other Names
Alirocumab	Drug	Alirocumab two SC injections in the abdomen only.	Alirocumab 150 mg Q2W Alirocumab 150 mg Q4W Alirocumab 200 mg Q4W Alirocumab 300 mg Q4W

Measure	Description	Time Frame
Percent Change From Baseline in Calculated LDL-C at Week 12 - On-treatment Analysis	Calculated LDL-C values were obtained using the Friedewald formula. Baseline adjusted least squares (LS) means and standard errors were estimated using an analysis of covariance (ANCOVA) model including available post-baseline data on treatment from first investigational medicinal product (IMP) injection up to 21 days after last IMP injection (on-treatment analysis). Missing Week 12 data were imputed by last observation carried forward [LOCF] method.	From Baseline to Week 12 (LOCF)

Measure	Description	Time Frame
Absolute Change From Baseline in Calculated LDL-C at Week 12 - On-treatment Analysis	Calculated LDL-C value was obtained from Friedewald formula. Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.	From Baseline to Week 12 (LOCF)
Percentage of Participants Achieving Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 12 - On-treatment Analysis

Name	Affiliation	Role
Clinical Trial Management	Regeneron Pharmaceuticals	Study Director

PubMed Identifier	Type	Citation	Retractions
30183102	Derived	Leiter LA, Tinahones FJ, Karalis DG, Bujas-Bobanovic M, Letierce A, Mandel J, Samuel R, Jones PH. Alirocumab safety in people with and without diabetes mellitus: pooled data from 14 ODYSSEY trials. Diabet Med. 2018 Dec;35(12):1742-1751. doi: 10.1111/dme.13817. Epub 2018 Oct 9.
28964736	Derived	Defesche JC, Stefanutti C, Langslet G, Hopkins PN, Seiz W, Baccara-Dinet MT, Hamon SC, Banerjee P, Kastelein JJP. Efficacy of alirocumab in 1191 patients with a wide spectrum of mutations in genes causative for familial hypercholesterolemia. J Clin Lipidol. 2017 Nov-Dec;11(6):1338-1346.e7. doi: 10.1016/j.jacl.2017.08.016. Epub 2017 Sep 4.

ID	Title	Description
FG000	Placebo	Placebo subcutaneous (SC) injection once every two weeks (Q2W) added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
FG001	Alirocumab 150 mg Q4W

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percent Change From Baseline in Calculated LDL-C at Week 12 - On-treatment Analysis

Calculated LDL-C values were obtained using the Friedewald formula. Baseline adjusted least squares (LS) means and standard errors were estimated using an analysis of covariance (ANCOVA) model including available post-baseline data on treatment from first investigational medicinal product (IMP) injection up to 21 days after last IMP injection (on-treatment analysis). Missing Week 12 data were imputed by last observation carried forward [LOCF] method.

Modified Intent-To-Treat (mITT) population included all randomized participants with one baseline and at least one post baseline on-treatment calculated LDL-C.

Posted

Least Squares Mean

Standard Error

percent change

From Baseline to Week 12 (LOCF)

ID	Title	Description
OG000	Placebo	Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
OG001	Alirocumab 150 mg Q4W	Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
OG002	Alirocumab 200 mg Q4W	Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
OG003	Alirocumab 300 mg Q4W	Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
OG004	Alirocumab 150 mg Q2W	Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.

Units	Counts
Participants	OG00015 OG00115 OG00216 OG003

Title

Denominators

Categories

Title	Measurements
	OG000-10.7± 5.0 OG001-28.9± 5.1 OG002-31.5± 4.9 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG004	Each treatment group was compared to placebo using ANCOVA-derived contrasts. A hierarchical testing procedure was applied to ensure strong control of overall Type-I error rate at 0.05 level. Order was following: Alirocumab 150 mg Q2W versus placebo Alirocumab 300 mg Q4W versus placebo Alirocumab 200 mg Q4W versus placebo Alirocumab 150 mg Q4W versus placebo Testing continued only when high-order test was statistically significant at 5% level.	ANCOVA		0.0000	Threshold for significance at ≤ 0.05.					2-Sided							No	Superiority or Other

Secondary

Absolute Change From Baseline in Calculated LDL-C at Week 12 - On-treatment Analysis

Calculated LDL-C value was obtained from Friedewald formula. Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.

mITT population included all randomized participants with one baseline and at least one on-treatment calculated LDL-C.

Posted

Least Squares Mean

Standard Error

mg/dL

From Baseline to Week 12 (LOCF)

ID	Title	Description
OG000	Placebo	Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
OG001	Alirocumab 150 mg Q4W	Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
OG002	Alirocumab 200 mg Q4W	Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
OG003	Alirocumab 300 mg Q4W	Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.

Secondary

Percentage of Participants Achieving Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 12 - On-treatment Analysis

Calculated LDL-C value was obtained from Friedewald formula.

mITT population included all randomized participants with one baseline and at least one on-treatment calculated LDL-C.

Posted

Number

percentage of participants

Week 12 (LOCF)

ID	Title	Description
OG000	Placebo	Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
OG001	Alirocumab 150 mg Q4W	Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
OG002	Alirocumab 200 mg Q4W	Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
OG003	Alirocumab 300 mg Q4W	Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.

Secondary

Percentage of Participants Achieving LDL-C < 70 mg/dL (1.81 mmol/L) at Week 12 - On-treatment Analysis

Calculated LDL-C value was obtained from Friedewald formula.

mITT population included all randomized participants with one baseline and at least one on-treatment calculated LDL-C.

Posted

Number

percentage of participants

Week 12 (LOCF)

ID	Title	Description
OG000	Placebo	Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
OG001	Alirocumab 150 mg Q4W	Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
OG002	Alirocumab 200 mg Q4W	Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
OG003	Alirocumab 300 mg Q4W	Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.

Secondary

Percent Change From Baseline in Total Cholesterol at Week 12 - On-treatment Analysis

Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.

mITT population included all randomized participants with one baseline and at least one on-treatment total cholesterol value.

Posted

Least Squares Mean

Standard Error

percent change

From Baseline to Week 12 (LOCF)

ID	Title	Description
OG000	Placebo	Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
OG001	Alirocumab 150 mg Q4W	Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
OG002	Alirocumab 200 mg Q4W	Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
OG003	Alirocumab 300 mg Q4W	Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.

Secondary

Absolute Change From Baseline in Total Cholesterol at Week 12 - On-treatment Analysis

Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.

mITT population included all randomized participants with one baseline and at least one post baseline on-treatment total cholesterol value.

Posted

Least Squares Mean

Standard Error

mg/dL

From Baseline to Week 12 (LOCF)

ID	Title	Description
OG000	Placebo	Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
OG001	Alirocumab 150 mg Q4W	Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
OG002	Alirocumab 200 mg Q4W	Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
OG003	Alirocumab 300 mg Q4W	Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.

Secondary

Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 - On-treatment Analysis

Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint..

mITT population included all randomized participants with one baseline and at least one on-treatment HDL-C value.

Posted

Least Squares Mean

Standard Error

percent change

From Baseline to Week 12 (LOCF)

ID	Title	Description
OG000	Placebo	Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
OG001	Alirocumab 150 mg Q4W	Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
OG002	Alirocumab 200 mg Q4W	Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
OG003	Alirocumab 300 mg Q4W	Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.

Secondary

Absolute Change From Baseline in HDL-C at Week 12 - On-treatment Analysis

Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.

mITT population included all randomized participants with one baseline and at least one post baseline HDL-C value.

Posted

Least Squares Mean

Standard Error

mg/dL

From Baseline to Week 12 (LOCF)

ID	Title	Description
OG000	Placebo	Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
OG001	Alirocumab 150 mg Q4W	Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
OG002	Alirocumab 200 mg Q4W	Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
OG003	Alirocumab 300 mg Q4W	Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.

Secondary

Percent Change From Baseline in Triglycerides at Week 12 - On-treatment Analysis

Since the assumptions of normal distribution and equality of variances were not verified for the lipid parameter, percent changes were expressed as median (interquartile range)

mITT population included all randomized participants with one baseline and at least one post baseline on-treatment fasting triglycerides value.

Posted

Median

Inter-Quartile Range

percent change

From Baseline to Week 12 (LOCF)

ID	Title	Description
OG000	Placebo	Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
OG001	Alirocumab 150 mg Q4W	Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
OG002	Alirocumab 200 mg Q4W	Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
OG003	Alirocumab 300 mg Q4W

Secondary

Absolute Change From Baseline in Triglycerides at Week at 12 - On-treatment Analysis

Since the assumptions of normal distribution and equality of variances were not verified for the lipid parameters, percent changes were expressed as median (interquartile range)

mITT population included all randomized participants with one baseline and at least one post baseline on-treatment fasting triglycerides value.

Posted

Median

Inter-Quartile Range

mg/dL

From Baseline to Week 12 (LOCF)

ID	Title	Description
OG000	Placebo	Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
OG001	Alirocumab 150 mg Q4W	Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
OG002	Alirocumab 200 mg Q4W	Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
OG003	Alirocumab 300 mg Q4W

Secondary

Percent Change From Baseline in Non-HDL-C at Week 12 - On-treatment Analysis

Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.

mITT population included all randomized participants with one baseline and at least one post baseline on-treatment non-HDL-C value.

Posted

Least Squares Mean

Standard Error

percent change

From Baseline to Week 12

ID	Title	Description
OG000	Placebo	Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
OG001	Alirocumab 150 mg Q4W	Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
OG002	Alirocumab 200 mg Q4W	Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
OG003	Alirocumab 300 mg Q4W	Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.

Secondary

Absolute Change From Baseline in Non-HDL-C at Week 12 - On-treatment Analysis

Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.

mITT population included all randomized participants with one baseline and at least one post baseline on-treatment non-HDL-C value.

Posted

Least Squares Mean

Standard Error

mg/dL

From Baseline to Week 12 (LOCF)

ID	Title	Description
OG000	Placebo	Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
OG001	Alirocumab 150 mg Q4W	Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
OG002	Alirocumab 200 mg Q4W	Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
OG003	Alirocumab 300 mg Q4W	Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.

Secondary

Percent Change From Baseline in Apo Lipoprotein B (Apo-B) at Week 12 - On-treatment Analysis

Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.

mITT population included all randomized participants with one baseline and at least one post baseline on-treatment Apo-B value.

Posted

Least Squares Mean

Standard Error

percent change

From Baseline to Week 12 (LOCF)

ID	Title	Description
OG000	Placebo	Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
OG001	Alirocumab 150 mg Q4W	Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
OG002	Alirocumab 200 mg Q4W	Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
OG003	Alirocumab 300 mg Q4W	Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.

Secondary

Absolute Change From Baseline in Apo-B at Week 12 - On-treatment Analysis

Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.

mITT population included all randomized participants with one baseline and at least one post baseline on-treatment Apo-B value.

Posted

Least Squares Mean

Standard Error

mg/dL

From Baseline to Week 12

ID	Title	Description
OG000	Placebo	Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
OG001	Alirocumab 150 mg Q4W	Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
OG002	Alirocumab 200 mg Q4W	Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
OG003	Alirocumab 300 mg Q4W	Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.

Secondary

Percent Change From Baseline in Apolipoprotein - A1 (Apo-A1) at Week 12 - On-treatment Analysis

Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.

mITT population included all randomized participants with one baseline and at least one post baseline on-treatment Apo-A1 value.

Posted

Least Squares Mean

Standard Error

percent change

From Baseline to Week 12 (LOCF)

ID	Title	Description
OG000	Placebo	Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
OG001	Alirocumab 150 mg Q4W	Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
OG002	Alirocumab 200 mg Q4W	Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
OG003	Alirocumab 300 mg Q4W	Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.

Secondary

Absolute Change From Baseline in Apo-A1 at Week 12 - On-treatment Analysis

Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.

mITT population included all randomized participants with one baseline and at least one post baseline on-treatment Apo-A1 value.

Posted

Least Squares Mean

Standard Error

mg/dL

From Baseline to Week 12 (LOCF)

ID	Title	Description
OG000	Placebo	Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
OG001	Alirocumab 150 mg Q4W	Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
OG002	Alirocumab 200 mg Q4W	Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
OG003	Alirocumab 300 mg Q4W	Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.

Secondary

Absolute Change in the Ratio ApoB/ApoA-1 From Baseline to Week 12 - On-treatment Analysis

Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.

mITT population included all randomized participants with one baseline and at least one post baseline on-treatment Apo-B and ApoA-1 value.

Posted

Least Squares Mean

Standard Error

ratio

From Baseline to Week 12

ID	Title	Description
OG000	Placebo	Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
OG001	Alirocumab 150 mg Q4W	Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
OG002	Alirocumab 200 mg Q4W	Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
OG003	Alirocumab 300 mg Q4W	Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.

Secondary

Percent Change From Baseline in Lipoprotein(a) at Week 12 - On-treatment Analysis

Since the assumptions of normal distribution and equality of variances were not verified for the lipid parameters, percent changes were expressed as median (interquartile range)

mITT population included all randomized participants with one baseline and at least one post baseline on-treatment lipoprotein(a) value.

Posted

Median

Inter-Quartile Range

percent change

From Baseline to Week 12 (LOCF)

ID	Title	Description
OG000	Placebo	Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
OG001	Alirocumab 150 mg Q4W	Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
OG002	Alirocumab 200 mg Q4W	Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
OG003	Alirocumab 300 mg Q4W

Secondary

Absolute Change From Baseline in Lipoprotein(a) at Week 12 - On-treatment Analysis

Since the assumptions of normal distribution and equality of variances were not verified for the lipid parameter, percent changes were expressed as median (interquartile range)

mITT population included all randomized participants with one baseline and at least one post baseline on-treatment lipoprotein(a) value.

Posted

Median

Inter-Quartile Range

mg/dL

From Baseline to Week 12 (LOCF)

ID	Title	Description
OG000	Placebo	Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
OG001	Alirocumab 150 mg Q4W	Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
OG002	Alirocumab 200 mg Q4W	Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
OG003	Alirocumab 300 mg Q4W

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (14.1)	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected15 at risk EG0020 events0 affected16 at risk EG0030 events0 affected15 at risk EG0040 events0 affected16 at risk
Cerumen impaction	Ear and labyrinth disorders	MedDRA (14.1)	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected15 at risk EG0020 events0 affected16 at risk EG003
Tinnitus	Ear and labyrinth disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected15 at risk EG0021 events1 affected16 at risk EG003
Conjunctivitis	Eye disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected15 at risk EG0020 events0 affected16 at risk EG003
Ocular icterus	Eye disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected15 at risk EG0020 events0 affected16 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected15 at risk EG0020 events0 affected16 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected15 at risk EG0021 events1 affected16 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected15 at risk EG0021 events1 affected16 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected15 at risk EG0020 events0 affected16 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected15 at risk EG0020 events0 affected16 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0014 events3 affected15 at risk EG0023 events3 affected16 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0012 events1 affected15 at risk EG0021 events1 affected16 at risk EG003
Gastritis erosive	Gastrointestinal disorders	MedDRA (14.1)	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected15 at risk EG0020 events0 affected16 at risk EG003
Gingivitis	Gastrointestinal disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected15 at risk EG0021 events1 affected16 at risk EG003
Gingivitis ulcerative	Gastrointestinal disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected15 at risk EG0021 events1 affected16 at risk EG003
Haematochezia	Gastrointestinal disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected15 at risk EG0020 events0 affected16 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected15 at risk EG0020 events0 affected16 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	MedDRA (14.1)	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected15 at risk EG0020 events0 affected16 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected15 at risk EG0020 events0 affected16 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected15 at risk EG0020 events0 affected16 at risk EG003
Chest discomfort	General disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected15 at risk EG0020 events0 affected16 at risk EG003
Chills	General disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected15 at risk EG0020 events0 affected16 at risk EG003
Fatigue	General disorders	MedDRA (14.1)	Systematic Assessment	EG0001 events1 affected15 at risk EG0013 events2 affected15 at risk EG0021 events1 affected16 at risk EG003
Feeling hot	General disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected15 at risk EG0020 events0 affected16 at risk EG003
Influenza like illness	General disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected15 at risk EG0021 events1 affected16 at risk EG003
Injection site discolouration	General disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected15 at risk EG0020 events0 affected16 at risk EG003
Injection site dryness	General disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected15 at risk EG0020 events0 affected16 at risk EG003
Injection site erythema	General disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0012 events2 affected15 at risk EG0026 events4 affected16 at risk EG003
Injection site exfoliation	General disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected15 at risk EG0022 events1 affected16 at risk EG003
Injection site haematoma	General disorders	MedDRA (14.1)	Systematic Assessment	EG0001 events1 affected15 at risk EG0014 events3 affected15 at risk EG0020 events0 affected16 at risk EG003
Injection site haemorrhage	General disorders	MedDRA (14.1)	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected15 at risk EG0022 events2 affected16 at risk EG003
Injection site oedema	General disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected15 at risk EG0020 events0 affected16 at risk EG003
Injection site pain	General disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0012 events1 affected15 at risk EG0020 events0 affected16 at risk EG003
Injection site paraesthesia	General disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected15 at risk EG0020 events0 affected16 at risk EG003
Injection site pruritus	General disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected15 at risk EG0020 events0 affected16 at risk EG003
Injection site rash	General disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected15 at risk EG0021 events1 affected16 at risk EG003
Injection site reaction	General disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected15 at risk EG0021 events1 affected16 at risk EG003
Injection site swelling	General disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected15 at risk EG0020 events0 affected16 at risk EG003
Injection site urticaria	General disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected15 at risk EG0021 events1 affected16 at risk EG003
Injection site vesicles	General disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected15 at risk EG0020 events0 affected16 at risk EG003
Non-Cardiac chest pain	General disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected15 at risk EG0020 events0 affected16 at risk EG003
Oedema peripheral	General disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected15 at risk EG0020 events0 affected16 at risk EG003
Pyrexia	General disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected15 at risk EG0020 events0 affected16 at risk EG003
Bronchitis	Infections and infestations	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected15 at risk EG0021 events1 affected16 at risk EG003
Diverticulitis	Infections and infestations	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected15 at risk EG0020 events0 affected16 at risk EG003
Fungal skin infection	Infections and infestations	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected15 at risk EG0020 events0 affected16 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected15 at risk EG0020 events0 affected16 at risk EG003
Infected bites	Infections and infestations	MedDRA (14.1)	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected15 at risk EG0020 events0 affected16 at risk EG003
Influenza	Infections and infestations	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected15 at risk EG0020 events0 affected16 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA (14.1)	Systematic Assessment	EG0003 events2 affected15 at risk EG0010 events0 affected15 at risk EG0022 events2 affected16 at risk EG003
Oral herpes	Infections and infestations	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected15 at risk EG0020 events0 affected16 at risk EG003
Pharyngitis streptococcal	Infections and infestations	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected15 at risk EG0020 events0 affected16 at risk EG003
Pneumonia	Infections and infestations	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected15 at risk EG0020 events0 affected16 at risk EG003
Prostate infection	Infections and infestations	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected15 at risk EG0020 events0 affected16 at risk EG003
Rhinitis	Infections and infestations	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected15 at risk EG0020 events0 affected16 at risk EG003
Sinusitis	Infections and infestations	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0012 events2 affected15 at risk EG0020 events0 affected16 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected15 at risk EG0020 events0 affected16 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected15 at risk EG0021 events1 affected16 at risk EG003
Vaginal infection	Infections and infestations	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected15 at risk EG0022 events1 affected16 at risk EG003
Concussion	Injury, poisoning and procedural complications	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected15 at risk EG0021 events1 affected16 at risk EG003
Epicondylitis	Injury, poisoning and procedural complications	MedDRA (14.1)	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected15 at risk EG0020 events0 affected16 at risk EG003
Hand fracture	Injury, poisoning and procedural complications	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected15 at risk EG0021 events1 affected16 at risk EG003
Laceration	Injury, poisoning and procedural complications	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected15 at risk EG0021 events1 affected16 at risk EG003
Limb injury	Injury, poisoning and procedural complications	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected15 at risk EG0021 events1 affected16 at risk EG003
Muscle injury	Injury, poisoning and procedural complications	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected15 at risk EG0020 events0 affected16 at risk EG003
Muscle strain	Injury, poisoning and procedural complications	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected15 at risk EG0020 events0 affected16 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected15 at risk EG0020 events0 affected16 at risk EG003
Tendon injury	Injury, poisoning and procedural complications	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected15 at risk EG0021 events1 affected16 at risk EG003
Tendon rupture	Injury, poisoning and procedural complications	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected15 at risk EG0021 events1 affected16 at risk EG003
Bacterial test positive	Investigations	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected15 at risk EG0020 events0 affected16 at risk EG003
Blood pressure increased	Investigations	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected15 at risk EG0020 events0 affected16 at risk EG003
Blood pressure systolic decreased	Investigations	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected15 at risk EG0020 events0 affected16 at risk EG003
Cardiac murmur	Investigations	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected15 at risk EG0020 events0 affected16 at risk EG003
Thyroxine decreased	Investigations	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected15 at risk EG0021 events1 affected16 at risk EG003
Urinary sediment present	Investigations	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected15 at risk EG0020 events0 affected16 at risk EG003
White blood cell count decreased	Investigations	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected15 at risk EG0020 events0 affected16 at risk EG003
Glucose tolerance impaired	Metabolism and nutrition disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected15 at risk EG0021 events1 affected16 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (14.1)	Systematic Assessment	EG0001 events1 affected15 at risk EG0012 events2 affected15 at risk EG0020 events0 affected16 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected15 at risk EG0021 events1 affected16 at risk EG003
Exostosis	Musculoskeletal and connective tissue disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected15 at risk EG0021 events1 affected16 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected15 at risk EG0020 events0 affected16 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected15 at risk EG0020 events0 affected16 at risk EG003
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected15 at risk EG0020 events0 affected16 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected15 at risk EG0021 events1 affected16 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected15 at risk EG0020 events0 affected16 at risk EG003
Plantar fasciitis	Musculoskeletal and connective tissue disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected15 at risk EG0021 events1 affected16 at risk EG003
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA (14.1)	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected15 at risk EG0020 events0 affected16 at risk EG003
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected15 at risk EG0021 events1 affected16 at risk EG003
Dizziness	Nervous system disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected15 at risk EG0021 events1 affected16 at risk EG003
Dizziness postural	Nervous system disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected15 at risk EG0020 events0 affected16 at risk EG003
Headache	Nervous system disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected15 at risk EG0021 events1 affected16 at risk EG003
Migraine	Nervous system disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected15 at risk EG0020 events0 affected16 at risk EG003
Migraine with aura	Nervous system disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected15 at risk EG0020 events0 affected16 at risk EG003
Sciatica	Nervous system disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected15 at risk EG0020 events0 affected16 at risk EG003
Depression	Psychiatric disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected15 at risk EG0020 events0 affected16 at risk EG003
Disorientation	Psychiatric disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected15 at risk EG0021 events1 affected16 at risk EG003
Panic attack	Psychiatric disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected15 at risk EG0020 events0 affected16 at risk EG003
Calculus urinary	Renal and urinary disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0012 events1 affected15 at risk EG0020 events0 affected16 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected15 at risk EG0021 events1 affected16 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected15 at risk EG0020 events0 affected16 at risk EG003
Micturition urgency	Renal and urinary disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected15 at risk EG0020 events0 affected16 at risk EG003
Haematospermia	Reproductive system and breast disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected15 at risk EG0021 events1 affected16 at risk EG003
Bronchial hyperreactivity	Respiratory, thoracic and mediastinal disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected15 at risk EG0020 events0 affected16 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected15 at risk EG0020 events0 affected16 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected15 at risk EG0020 events0 affected16 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0013 events2 affected15 at risk EG0021 events1 affected16 at risk EG003
Rales	Respiratory, thoracic and mediastinal disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected15 at risk EG0021 events1 affected16 at risk EG003
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected15 at risk EG0020 events0 affected16 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA (14.1)	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected15 at risk EG0020 events0 affected16 at risk EG003
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected15 at risk EG0020 events0 affected16 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected15 at risk EG0020 events0 affected16 at risk EG003
Petechiae	Skin and subcutaneous tissue disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected15 at risk EG0020 events0 affected16 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected15 at risk EG0020 events0 affected16 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected15 at risk EG0021 events1 affected16 at risk EG003
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected15 at risk EG0021 events1 affected16 at risk EG003
Skin burning sensation	Skin and subcutaneous tissue disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected15 at risk EG0020 events0 affected16 at risk EG003
Flushing	Vascular disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected15 at risk EG0021 events1 affected16 at risk EG003
Hypertension	Vascular disorders	MedDRA (14.1)	Systematic Assessment	EG0002 events2 affected15 at risk EG0010 events0 affected15 at risk EG0020 events0 affected16 at risk EG003

Facility	Status	City	State	ZIP	Country	Contacts
		Huntsville	Alabama		United States

ID	Term
D006949	Hyperlipidemias
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Title	Description
BG000	Placebo	Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
BG001	Alirocumab 150 mg Q4W	Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
BG002	Alirocumab 200 mg Q4W	Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
BG003	Alirocumab 300 mg Q4W	Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
BG004	Alirocumab 150 mg Q2W	Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
BG005	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	1	15	9	15
EG001	Alirocumab 150 mg Q4W	Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	0	15	12	15
EG002	Alirocumab 200 mg Q4W	Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	0	16	13	16
EG003	Alirocumab 300 mg Q4W	Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	0	15	13	15
EG004	Alirocumab 150 mg Q2W	Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	0	16	12	16