Open-Label Extension of Study R727-CL-1003 (NCT01266876)... | NCT01576484

Name	Class
Sanofi	INDUSTRY

Label	Type	Description	Intervention Names
Placebo Matched to Alirocumab	Placebo Comparator	Participants who received placebo in parent study (NCT01576484), has received a subcutaneous injection of placebo matched to alirocumab every 2 weeks for 4 years in this study.	Drug: Placebo Matched to Alirocumab
Alirocumab 150 mg	Experimental	Participants who received alirocumab in parent study (NCT01576484), has received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.	Drug: Alirocumab

Name	Type	Description	Arm Group Labels	Other Names
Alirocumab	Drug	Alirocumab was supplied in a pre-filled syringe and administered subcutaneously (SC) in the abdomen, thigh, or outer upper arm; REGN727(SAR236553) is an anti-PCSK9 (proprotein convertase subtilisin/kexin type 9) antibody

Measure	Description	Time Frame
Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Leading to Death	An AE was defined as any untoward medical occurrence in a participant administered a study drug which may or may not have a causal relationship with the study drug. Treatment- emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on- treatment period (time from the first dose of study drug to the last dose of study drug plus 70 days). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life- threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.	Baseline (Day 1 of current study) to end of study (Week 218)

Measure	Description	Time Frame
Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline in the Current Study to Week 24	Percent change for serum LDL-C (Low-density lipoprotein cholesterol) from baseline to Week 24 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.	Baseline (current study) to Week 24

Name	Affiliation	Role
Clinical Trial Management	Regeneron Pharmaceuticals	Study Director

PubMed Identifier	Type	Citation	Retractions
27886619	Derived	Dufour R, Bergeron J, Gaudet D, Weiss R, Hovingh GK, Qing Z, Yang F, Andisik M, Torri A, Pordy R, Gipe DA. Open-label therapy with alirocumab in patients with heterozygous familial hypercholesterolemia: Results from three years of treatment. Int J Cardiol. 2017 Feb 1;228:754-760. doi: 10.1016/j.ijcard.2016.11.046. Epub 2016 Nov 9.

ID	Title	Description
FG000	Placebo Participants in Parent Study	Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.
FG001	Participants Previously Exposed to Alirocumab in Parent Study

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

Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Leading to Death

An AE was defined as any untoward medical occurrence in a participant administered a study drug which may or may not have a causal relationship with the study drug. Treatment- emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on- treatment period (time from the first dose of study drug to the last dose of study drug plus 70 days). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life- threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.

Safety Analysis Set (SAF) included all participants who received at least 1 dose or part of a dose of alirocumab.

Posted

Count of Participants

Participants

Baseline (Day 1 of current study) to end of study (Week 218)

ID	Title	Description
OG000	Placebo Participants in Parent Study	Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.
OG001	Participants Previously Exposed to Alirocumab in Parent Study	Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.
OG002	All Participants	All participants who received placebo or alirocumab in the parent study (NCT01576484).

Units	Counts
Participants	OG00012 OG00146 OG00258

Title

Denominators

Categories

Adverse Events

Title	Measurements
	OG00012 OG00142 OG00254

Serious Adverse Events

Secondary

Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline in the Current Study to Week 24

Percent change for serum LDL-C (Low-density lipoprotein cholesterol) from baseline to Week 24 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.

SAF included all participants who received at least 1 dose or part of a dose of alirocumab. Here, "overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.

Posted

Mean

Standard Deviation

percent change

Baseline (current study) to Week 24

ID	Title	Description
OG000	Placebo Participants in Parent Study	Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.
OG001	Participants Previously Exposed to Alirocumab in Parent Study	Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.
OG002	All Participants	All participants who received placebo or alirocumab in the parent study (NCT01576484).

Secondary

Percent Change in Low Density Lipoprotein Cholesterol (LDL-C) From Baseline in Current Study to Week 12

Percent change for serum LDL-C (Low-density lipoprotein cholesterol) from baseline to Week 12 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.

Posted

Mean

Standard Deviation

percent change

Baseline (current study) up to Week 12

ID	Title	Description
OG000	Placebo Participants in Parent Study	Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.
OG001	Participants Previously Exposed to Alirocumab in Parent Study	Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.
OG002	All Participants	All participants who received placebo or alirocumab in the parent study (NCT01576484).

Secondary

Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), and Total Cholesterol From Baseline in Current Study to Week 24

Percent change for Apo B, Non-HDL-C and Total Cholesterol from baseline to Week 24 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.

SAF included all participants who received at least 1 dose or part of a dose of alirocumab. Here "Number analyzed" signifies those participants who were evaluable for this outcome measure at specified category.

Posted

Mean

Standard Deviation

percent change

Baseline(current study) up to Week 24

ID	Title	Description
OG000	Placebo Participants in Parent Study	Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.
OG001	Participants Previously Exposed to Alirocumab in Parent Study	Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.
OG002	All Participants

Secondary

Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), and Total Cholesterol From Baseline in Current Study to Week 12

Percent change for serum Apo B, Non-HDL-C, and Total Cholesterol from baseline to Week 12 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.

Posted

Mean

Standard Deviation

percent change

Baseline (current study) up to Week 12

ID	Title	Description
OG000	Placebo Participants in Parent Study	Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.
OG001	Participants Previously Exposed to Alirocumab in Parent Study	Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.
OG002	All Participants

Secondary

Percent Change in Low Density Lipoprotein Cholesterol (LDL-C) From Baseline in Current Study to Week 52

Percent change for serum LDL-C from baseline to Week 52 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.

Posted

Mean

Standard Deviation

percent change

Baseline (current study) up to Week 52

ID	Title	Description
OG000	Placebo Participants in Parent Study	Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.
OG001	Participants Previously Exposed to Alirocumab in Parent Study	Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.
OG002	All Participants	All participants who received placebo or alirocumab in the parent study (NCT01576484).

Secondary

Percentage of Participants With Low Density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 Milligrams Per Deciliter (mg/dL) for Prior Myocardial Infarction (MI)/Stroke, or <100 mg/dL [2.59 mmol/L] for Participants Without Prior MI/Stroke at Week 24

Percentage of participants reaching LDL-C goal (ie, LDL-C <70 mg/dL (1.81 millimoles per liter [mmol/L]) in case of prior MI/stroke, or <100 mg/dL [2.59 mmol/L] for participants without prior MI/stroke) at week 24 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study, were reported.

Posted

Number

Percentage of Participants

At Week 24

ID	Title	Description
OG000	Placebo Participants in Parent Study	Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.
OG001	Participants Previously Exposed to Alirocumab in Parent Study	Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.

Secondary

Percent Change in Lipoprotein a (Lp[a]) at Week 24

Percent change in serum lipoprotein a at week 24 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study, was reported.

Posted

Mean

Standard Deviation

percent change

At Week 24

ID	Title	Description
OG000	Placebo Participants in Parent Study	Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.
OG001	Participants Previously Exposed to Alirocumab in Parent Study	Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.
OG002	All Participants	All participants who received placebo or alirocumab in the parent study (NCT01576484).

Secondary

Percent Change in High Density Lipoprotein Cholesterol (HDL-C) at Week 24 and Week 12

Percent change for serum High Density Lipoprotein Cholesterol (HDL-C) in the current study at weeks 24 and week 12, during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study, was reported.

Posted

Mean

Standard Deviation

percent change

At Week 24 and 12

ID	Title	Description
OG000	Placebo Participants in Parent Study	Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.
OG001	Participants Previously Exposed to Alirocumab in Parent Study	Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.
OG002	All Participants	All participants who received placebo or alirocumab in the parent study (NCT01576484).

Secondary

Percent Change in Lipoprotein a at Week 12

Percent change for serum Lipoprotein a at Week 12 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study, was reported.

Posted

Mean

Standard Deviation

percent change

At Week 12

ID	Title	Description
OG000	Placebo Matched to R727	Participants who received placebo in parent study has received a subcutaneous injection of placebo matched to alirocumab every 2 weeks for 4 years in this study.
OG001	Participants Previously Exposed to Alirocumab in Parent Study	Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.
OG002	All Participants	All participants who received placebo or alirocumab in the parent study (NCT01576484).

Secondary

Percent Change in Triglycerides (TG) at Week 24 and Week 12

Percent change for serum TG at Week 24 and Week 12 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study, was reported.

SAF included all participants who received at least 1 dose or part of a dose of alirocumab. Here, "Number analyzed" signifies those participants who were evaluable for this outcome measure.

Posted

Mean

Standard Deviation

percent change

At Week 24 and 12

ID	Title	Description
OG000	Placebo Participants in Parent Study	Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.
OG001	Participants Previously Exposed to Alirocumab in Parent Study	Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.
OG002	All Participants	All participants who received placebo or alirocumab in the parent study (NCT01576484).

Secondary

Percent Change in Apolipoprotein A-1 (Apo A-1) at Week 24 and Week 12

Percent change for serum Apo A-1 at Week 24 and Week 12 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study, was reported.

Posted

Mean

Standard Deviation

percent change

At Week 24 and Week 12

ID	Title	Description
OG000	Placebo Participants in Parent Study	Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.
OG001	Participants Previously Exposed to Alirocumab in Parent Study	Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.
OG002	All Participants	All participants who received placebo or alirocumab in the parent study (NCT01576484).

Secondary

Percent Change in Low Density Lipoprotein Cholesterol (LDL-C) From Baseline in the Current Study to the End of Treatment

Percent change for serum LDL-C from baseline to Week 208 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.

Posted

Mean

Standard Deviation

percent change

Baseline (current study) to the End of Treatment (Week 208)

ID	Title	Description
OG000	Placebo Participants in Parent Study	Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.
OG001	Participants Previously Exposed to Alirocumab in Parent Study	Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.
OG002	All Participants	All participants who received placebo or alirocumab in the parent study (NCT01576484).

Secondary

Percentage of Participants With Low Density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 Milligrams Per Deciliter (mg/dL) for Prior MI/Stroke, or <100 mg/dL [2.59 mmol/L] for Participants Without Prior MI/Stroke at Week 12, 52 and End of Treatment

Percentage of participants reaching LDL-C goal (ie, LDL-C <70 mg/dL (1.81 millimoles per liter [mmol/L]) in case of prior MI/stroke, or <100 mg/dL [2.59 mmol/L] for participants without prior MI/stroke) at week 12, 52 and end of treatment, during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study, were reported.

Posted

Number

percentage of participants

At Week 12, 52 and End of Treatment (Week 208)

ID	Title	Description
OG000	Placebo Participants in Parent Study	Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.
OG001	Participants Previously Exposed to Alirocumab in Parent Study	Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.

Secondary

Absolute Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline in the Current Study to Weeks 12, 24, 52, and End of Treatment

Absolute change was reported for serum LDL-C from baseline to weeks 12, 24, 52, and end of Treatment (Week 208) during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.

Posted

Mean

Standard Deviation

Milligram per Deciliter (mg/dL)

Baseline (current study) to Weeks 12, 24, 52, and End of Treatment (Week 208)

ID	Title	Description
OG000	Placebo Participants in Parent Study	Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.
OG001	Participants Previously Exposed to Alirocumab in Parent Study	Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.
OG002	All Participants

Secondary

Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol, Lipoprotein a (Lp[a]), HDL-C, Triglycerides, and Apolipoprotein A-1 From Baseline in Current Study to Week 52 and End of Treatment

Percent change was reported for serum (Apo B), non-HDL-C, total-C, Lp(a), HDL-C, TG, and Apo A-1 from baseline to weeks 52 and end of treatment (Week 208) during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.

Posted

Mean

Standard Deviation

percent change

Baseline (current study) up to Weeks 52 and End of Treatment (Week 208)

ID	Title	Description
OG000	Placebo Participants in Parent Study	Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.
OG001	Participants Previously Exposed to Alirocumab in Parent Study	Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.

Secondary

Change in Ratio in Apolipoprotein (Apo) B/Apo A-1 From Baseline in Current Study to Week 12, 24, 52, and End of Treatment.

Change in ratio in Apolipoprotein (Apo) B/Apo A-1 from baseline in current Study to week 12, 24, 52, and end of treatment (Week 208) during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.

Posted

Mean

Standard Deviation

Ratio

Baseline (current study) to Weeks 12, 24, 52, and End of Treatment (Week 208)

ID	Title	Description
OG000	Placebo Participants in Parent Study	Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.
OG001	Participants Previously Exposed to Alirocumab in Parent Study	Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.
OG002	All Participants

Secondary

Percentage of Participants With Apolipoprotein (Apo) B <80 mg/dL at Week 12, 24, 52, and End of Treatment

Percentage of participants was calculated with Apo B <80 mg/dL (0.8 mmol/L) at week 12, 24, 52, and End of Treatment (Week 208) during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.

Posted

Number

percentage of participants

At Week 12, 24, 52, and End of Treatment (Week 208)

ID	Title	Description
OG000	Placebo Participants in Parent Study	Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.
OG001	Participants Previously Exposed to Alirocumab in Parent Study	Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.
OG002	All Participants

Secondary

Percentage of Participants With Non-High Density Lipoprotein Cholesterol (HDL-C) <100 mg/dL (2.59 mmol/L) at Week 12, 24, 52, and End of Treatment

Percentage of participants was calculated with non-HDL-C <100 mg/dL (2.59 mmol/L) at Weeks 12, 24, 52, and End of Treatment (Week 208) during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.

Posted

Number

percentage of participants

At Week 12, 24, 52, and End of Treatment (Week 208)

ID	Title	Description
OG000	Placebo Participants in Parent Study	Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.
OG001	Participants Previously Exposed to Alirocumab in Parent Study	Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.
OG002	All Participants

Secondary

Percentage of Participants With Low Density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 Milligrams Per Deciliter (mg/dL) and/or ≥ 50% Reduction in LDL-C (if LDL-C >70 mg/dL [1.81 mmol/L]) at Week 12, 24, 52, and End of Treatment

Percentage of Participants was calculated with LDL-C <70 mg/dL (1.81 mmol/L) and/or ≥ 50% Reduction in LDL-C (if LDL-C >70 mg/dL [1.81 mmol/L]) at Weeks 12, 24, 52, and End of Treatment (Week 208) during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.

Posted

Number

percentage of participants

At Week 12, 24, 52, and End of Treatment (Week 208)

ID	Title	Description
OG000	Placebo Participants in Parent Study	Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.
OG001	Participants Previously Exposed to Alirocumab in Parent Study	Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0012 events2 affected46 at risk
Angina pectoris	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected46 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected46 at risk
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected46 at risk
Cerumen impaction	Ear and labyrinth disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected46 at risk
Ear pain	Ear and labyrinth disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected46 at risk
Glucose tolerance impaired	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected46 at risk
Cataract	Eye disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0012 events1 affected46 at risk
Eyelid oedema	Eye disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected46 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0012 events2 affected46 at risk
Anorectal discomfort	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected46 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected12 at risk EG0018 events6 affected46 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0011 events1 affected46 at risk
Eructation	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected46 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0014 events3 affected46 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected46 at risk
Nausea	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0014 events3 affected46 at risk
Vomiting	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected12 at risk EG0018 events5 affected46 at risk
Fatigue	General disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected12 at risk EG0013 events3 affected46 at risk
Injection site bruising	General disorders	MedDRA 19.1	Systematic Assessment	EG00016 events5 affected12 at risk EG00110 events6 affected46 at risk
Injection site discolouration	General disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0011 events1 affected46 at risk
Injection site erythema	General disorders	MedDRA 19.1	Systematic Assessment	EG0007 events2 affected12 at risk EG0010 events0 affected46 at risk
Injection site haemorrhage	General disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected12 at risk EG00110 events7 affected46 at risk
Injection site induration	General disorders	MedDRA 19.1	Systematic Assessment	EG0003 events1 affected12 at risk EG0010 events0 affected46 at risk
Injection site mass	General disorders	MedDRA 19.1	Systematic Assessment	EG0002 events1 affected12 at risk EG0015 events2 affected46 at risk
Injection site pain	General disorders	MedDRA 19.1	Systematic Assessment	EG00011 events2 affected12 at risk EG0015 events4 affected46 at risk
Injection site pruritus	General disorders	MedDRA 19.1	Systematic Assessment	EG00019 events1 affected12 at risk EG0010 events0 affected46 at risk
Injection site swelling	General disorders	MedDRA 19.1	Systematic Assessment	EG00019 events1 affected12 at risk EG0011 events1 affected46 at risk
Injection site urticaria	General disorders	MedDRA 19.1	Systematic Assessment	EG0008 events1 affected12 at risk EG0010 events0 affected46 at risk
Pain	General disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected46 at risk
Allergy to chemicals	Immune system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected46 at risk
Seasonal allergy	Immune system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected12 at risk EG0014 events3 affected46 at risk
Bronchitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected12 at risk EG00111 events10 affected46 at risk
Chronic sinusitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected46 at risk
Conjunctivitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected12 at risk EG0015 events3 affected46 at risk
Ear infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected12 at risk EG0011 events1 affected46 at risk
Gastroenteritis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0015 events5 affected46 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected12 at risk EG0014 events3 affected46 at risk
Influenza	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected12 at risk EG0015 events5 affected46 at risk
Localised infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected46 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected46 at risk
Nasopharyngitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0003 events2 affected12 at risk EG00121 events11 affected46 at risk
Onychomycosis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected46 at risk
Pharyngitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0011 events1 affected46 at risk
Sinusitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0016 events5 affected46 at risk
Tooth infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected12 at risk EG0014 events3 affected46 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0009 events4 affected12 at risk EG00122 events13 affected46 at risk
Urinary tract infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0003 events2 affected12 at risk EG0017 events5 affected46 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0011 events1 affected46 at risk
Accidental overdose	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0002 events1 affected12 at risk EG0010 events0 affected46 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0011 events1 affected46 at risk
Epicondylitis	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected12 at risk EG0010 events0 affected46 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0015 events5 affected46 at risk
Muscle contusion	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected46 at risk
Muscle injury	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected46 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected46 at risk
Nasal injury	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected46 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected12 at risk EG0013 events3 affected46 at risk
C-Reactive protein increased	Investigations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0011 events1 affected46 at risk
International normalised ratio increased	Investigations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected46 at risk
Gout	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected46 at risk
Impaired fasting glucose	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected46 at risk
Ketoacidosis	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected46 at risk
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0011 events1 affected46 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0008 events3 affected12 at risk EG00115 events8 affected46 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected12 at risk EG00112 events9 affected46 at risk
Dupuytren's contracture	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected46 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected12 at risk EG0014 events3 affected46 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG00113 events8 affected46 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected12 at risk EG0013 events3 affected46 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected12 at risk EG0014 events4 affected46 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0003 events2 affected12 at risk EG0015 events4 affected46 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected46 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0013 events3 affected46 at risk
Amnesia	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected46 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0012 events2 affected46 at risk
Cervical radiculopathy	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected46 at risk
Dizziness	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0002 events1 affected12 at risk EG0017 events6 affected46 at risk
Headache	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG00112 events10 affected46 at risk
Hyperaesthesia	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected46 at risk
Hypersomnia	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected46 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0011 events1 affected46 at risk
Migraine	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected46 at risk
Neuralgia	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0002 events1 affected12 at risk EG0010 events0 affected46 at risk
Paraesthesia	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0012 events1 affected46 at risk
Restless legs syndrome	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected46 at risk
Sciatica	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0012 events2 affected46 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected46 at risk
Anxiety	Psychiatric disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected12 at risk EG0016 events5 affected46 at risk
Depression	Psychiatric disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected12 at risk EG0013 events3 affected46 at risk
Sleep disorder	Psychiatric disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected46 at risk
Proteinuria	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected46 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected12 at risk EG0015 events5 affected46 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0011 events1 affected46 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0013 events2 affected46 at risk
Nasal septum deviation	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected46 at risk
Nasal turbinate hypertrophy	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected46 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0013 events3 affected46 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected46 at risk
Tonsillar hypertrophy	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected46 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected46 at risk
Dermal cyst	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected46 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected46 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected46 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected46 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0014 events3 affected46 at risk
Hypertension	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected12 at risk EG0015 events5 affected46 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Mission Viejo	California		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 Participants in Parent Study	Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.
BG001	Participants Previously Exposed to Alirocumab in Parent Study	Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo Participants in Parent Study	Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.	0	12	4	12	12	12
EG001	Participants Previously Exposed to Alirocumab in Parent Study	Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.	0	46	8	46	38	46

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Angina unstable	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected12 at risk EG0011 events1 affected46 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected46 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected12 at risk EG0011 events1 affected46 at risk
Atrial flutter	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected12 at risk EG0011 events1 affected46 at risk
Coronary artery disease	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected12 at risk EG0011 events1 affected46 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected12 at risk EG0011 events1 affected46 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected12 at risk EG0011 events1 affected46 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected46 at risk
Gastrointestinal viral infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected12 at risk EG0011 events1 affected46 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected12 at risk EG0011 events1 affected46 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected12 at risk EG0011 events1 affected46 at risk
Amnesia	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected46 at risk
Carotid artery disease	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected46 at risk
Neuropsychiatric symptoms	Psychiatric disorders	MedDRA 19.1	Systematic Assessment	EG0002 events1 affected12 at risk EG0010 events0 affected46 at risk