Randomized Clinical Trial of Bococizumab (PF-04950615; RN... | NCT02100514

ID	Type	Description	Link
SPIRE-LL	Other Identifier	Alias Study Number
2014-000478-20	EudraCT Number

Label	Type	Description	Intervention Names
Bococizumab (PF-04950615; RN316)	Experimental	Bococizumab (PF-04950615; RN316)	Drug: Bococizumab (PF-04950615; RN316)
placebo	Placebo Comparator		Other: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Bococizumab (PF-04950615; RN316)	Drug	150 mg every 2 weeks, subcutaneous injection for 52 weeks.	Bococizumab (PF-04950615; RN316)

Measure	Description	Time Frame
Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12		Baseline, Week 12

Measure	Description	Time Frame
Percent Change From Baseline in Fasting Total Cholesterol (TC) at Week 12, 24 and 52		Baseline, Week 12, 24, 52
Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12, 24 and 52		Baseline, Week 12, 24, 52

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Advanced Cardiovascular, LLC Research		Alexander City	Alabama	35010	United States
Advanced Cardiovascular, LLC, Research

PubMed Identifier	Type	Citation	Retractions
37994400	Derived	Wang EQ, Kaila N, Plowchalk D, Gibiansky L, Yunis C, Sweeney K. Population PK/PD modeling of low-density lipoprotein cholesterol response in hypercholesterolemic participants following administration of bococizumab, a potent anti-PCSK9 monoclonal antibody. CPT Pharmacometrics Syst Pharmacol. 2023 Dec;12(12):2013-2026. doi: 10.1002/psp4.13050. Epub 2023 Nov 22.
37658997

Label	URL
To obtain contact information for a study center near you, click here.	View source

ID	Title	Description
FG000	Treatment Period: Placebo	Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
FG001	Treatment Period: Bococizumab 150 mg

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 Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12

FAS included all participants who were randomized. Here, "Number of participants analyzed (N)" signifies number of participants who were evaluable for this outcome measure.

Posted

Mean

Standard Deviation

percent change

Baseline, Week 12

ID	Title	Description
OG000	Treatment Period: Placebo	Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
OG001	Treatment Period: Bococizumab 150 mg	Participants received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.

Units	Counts
Participants	OG000235 OG001468

Title

Denominators

Categories

Title	Measurements
	OG000-0.8± 17.61 OG001-50.8± 29.81

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 OG001	Least square (LS) mean difference and associated 95% confidence interval (CI), and p-value were derived from an mixed effect model repeat measurement (MMRM) model with fixed effects for treatment group, visit, treatment groupvisit interaction, baseline value, baseline valuevisit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.	MMRM		<0.001		LS mean difference compared to placebo	-49.9	Standard Error of the Mean	2.09	2-Sided	95	-54.0	-45.8					Superiority or Other

Secondary

Percent Change From Baseline in Fasting Total Cholesterol (TC) at Week 12, 24 and 52

FAS included all participants who were randomized. Here, "n" signifies number of participants who were evaluable at the specified time points.

Posted

Mean

Standard Deviation

percent change

Baseline, Week 12, 24, 52

ID	Title	Description
OG000	Treatment Period: Placebo	Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
OG001	Treatment Period: Bococizumab 150 mg	Participants received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12, 24 and 52

FAS included all participants who were randomized. Here, "n" signifies number of participants who were evaluable at the specified time points.

Posted

Mean

Standard Deviation

percent change

Baseline, Week 12, 24, 52

ID	Title	Description
OG000	Treatment Period: Placebo	Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
OG001	Treatment Period: Bococizumab 150 mg	Participants received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12, 24 and 52

FAS included all participants who were randomized. Here, "n" signifies number of participants who were evaluable at the specified time points.

Posted

Mean

Standard Deviation

percent change

Baseline, Week 12, 24, 52

ID	Title	Description
OG000	Treatment Period: Placebo	Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
OG001	Treatment Period: Bococizumab 150 mg	Participants received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Less Than (<) 200 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52

A subset of FAS included all participants who were randomized and had TG <200 mg/dL at pre-randomization. Here, "n" signifies number of participants who were evaluable at the specified time points.

Posted

Mean

Standard Deviation

percent change

Baseline, Week 12, 24, 52

ID	Title	Description
OG000	Treatment Period: Placebo	Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
OG001	Treatment Period: Bococizumab 150 mg	Participants received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Greater Than or Equal to (>=) 200 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52

A subset of FAS included all participants who were randomized and had TG >=200 mg/dL at pre-randomization. Here, "n" signifies number of participants evaluable at specified time points.

Posted

Mean

Standard Deviation

percent change

Baseline, Week 12, 24, 52

ID	Title	Description
OG000	Treatment Period: Placebo	Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
OG001	Treatment Period: Bococizumab 150 mg	Participants received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Fasting Lipoprotein (A) (Lp[A]) at Week 12, 24 and 52

FAS included all participants who were randomized. Here, "n" signifies number of participants who were evaluable at the specified time points.

Posted

Mean

Standard Deviation

percent change

Baseline, Week 12, 24, 52

ID	Title	Description
OG000	Treatment Period: Placebo	Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
OG001	Treatment Period: Bococizumab 150 mg	Participants received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52

FAS included all participants who were randomized. Here, "n" signifies number of participants who were evaluable at specified time points.

Posted

Mean

Standard Deviation

percent change

Baseline, Week 12, 24, 52

ID	Title	Description
OG000	Treatment Period: Placebo	Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
OG001	Treatment Period: Bococizumab 150 mg	Participants received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24, 52: Treatment Period

FAS included all participants who were randomized. Here, "n" signifies number of participants who were evaluable at specified time points.

Posted

Mean

Standard Deviation

percent change

Baseline, Week 24, 52

ID	Title	Description
OG000	Treatment Period: Placebo	Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
OG001	Treatment Period: Bococizumab 150 mg	Participants received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Fasting Triglycerides (TG) at Week 12, 24 and 52

FAS included all participants who were randomized. Here, "n" signifies number of participants who were evaluable at specified time points.

Posted

Mean

Standard Deviation

percent change

Baseline, Week 12, 24, 52

ID	Title	Description
OG000	Treatment Period: Placebo	Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
OG001	Treatment Period: Bococizumab 150 mg	Participants received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Fasting Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52

FAS included all participants who were randomized. Here, "n" signifies number of participants who were evaluable at specified time points.

Posted

Mean

Standard Deviation

percent change

Baseline, Week 12, 24, 52

ID	Title	Description
OG000	Treatment Period: Placebo	Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
OG001	Treatment Period: Bococizumab 150 mg	Participants received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Fasting Apolipoprotein A-II (ApoA-II) at Week 12, 24 and 52

FAS included all participants who were randomized. Here, "n" signifies number of participants who were evaluable at specified time points.

Posted

Mean

Standard Deviation

percent change

Baseline, Week 12, 24, 52

ID	Title	Description
OG000	Treatment Period: Placebo	Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
OG001	Treatment Period: Bococizumab 150 mg	Participants received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Fasting Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 12, 24 and 52

FAS included all participants who were randomized. Here, "n" signifies number of participants who were evaluable at specified time points.

Posted

Mean

Standard Deviation

percent change

Baseline, Week 12, 24, 52

ID	Title	Description
OG000	Treatment Period: Placebo	Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
OG001	Treatment Period: Bococizumab 150 mg	Participants received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.

Units	Counts
Participants	OG000

Secondary

Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Less Than (<) 200 Milligram Per Deciliter (mg/dL) at Week 12

A subset of FAS included all participants who were randomized and had TG <200 mg/dL at pre-randomization. Here, "n" signifies number of participants evaluable at specified time points.

Posted

Mean

Standard Deviation

mg/dL

Baseline, Week 12

ID	Title	Description
OG000	Treatment Period: Placebo	Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
OG001	Treatment Period: Bococizumab 150 mg	Participants received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.

Units	Counts
Participants	OG000

Secondary

Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Greater Than or Equal to (>=) 200 Milligram Per Deciliter (mg/dL) at Week 12

A subset of FAS included all participants who were randomized and had TG >=200 mg/dL at pre-randomization. Here, "n" signifies number of participants evaluable at specified time points.

Posted

Mean

Standard Deviation

mg/dL

Baseline, Week 12

ID	Title	Description
OG000	Treatment Period: Placebo	Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
OG001	Treatment Period: Bococizumab 150 mg	Participants received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.

Units	Counts
Participants	OG000

Secondary

Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12

FAS included all participants who were randomized. Here, "n" signifies number of participants who were evaluable at specified time points.

Posted

Mean

Standard Deviation

mg/dL

Baseline, Week 12

ID	Title	Description
OG000	Treatment Period: Placebo	Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
OG001	Treatment Period: Bococizumab 150 mg	Participants received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.

Units	Counts
Participants	OG000

Secondary

Absolute Change From Baseline in Fasting Total Cholesterol (TC) at Week 12

FAS included all participants who were randomized. Here, "n" signifies number of participants who were evaluable at specified time points.

Posted

Mean

Standard Deviation

mg/dL

Baseline, Week 12

ID	Title	Description
OG000	Treatment Period: Placebo	Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
OG001	Treatment Period: Bococizumab 150 mg	Participants received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.

Units	Counts
Participants	OG000

Secondary

Absolute Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12

FAS included all participants who were randomized. Here, "n" signifies number of participants who were evaluable at specified time points.

Posted

Mean

Standard Deviation

mg/dL

Baseline, Week 12

ID	Title	Description
OG000	Treatment Period: Placebo	Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
OG001	Treatment Period: Bococizumab 150 mg	Participants received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.

Units	Counts
Participants	OG000

Secondary

Absolute Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12

FAS included all participants who were randomized. Here, "n" signifies number of participants who were evaluable at specified time points.

Posted

Mean

Standard Deviation

mg/dL

Baseline, Week 12

ID	Title	Description
OG000	Treatment Period: Placebo	Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
OG001	Treatment Period: Bococizumab 150 mg	Participants received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.

Units	Counts
Participants	OG000

Secondary

Absolute Change From Baseline in Fasting Lipoprotein (A) (Lp[A]) at Week 12

FAS included all participants who were randomized. Here, "n" signifies number of participants who were evaluable at specified time points.

Posted

Mean

Standard Deviation

mg/dL

Baseline, Week 12

ID	Title	Description
OG000	Treatment Period: Placebo	Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
OG001	Treatment Period: Bococizumab 150 mg	Participants received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.

Units	Counts
Participants	OG000

Secondary

Absolute Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12

FAS included all participants who were randomized. Here, "n" signifies number of participants who were evaluable at specified time points.

Posted

Mean

Standard Deviation

mg/dL

Baseline, Week 12

ID	Title	Description
OG000	Treatment Period: Placebo	Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
OG001	Treatment Period: Bococizumab 150 mg	Participants received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.

Units	Counts
Participants	OG000

Secondary

Absolute Change From Baseline in Ratio of Fasting Total Cholesterol (TC) to High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52

FAS included all participants who were randomized. Here, "n" signifies number of participants who were evaluable at specified time points.

Posted

Mean

Standard Deviation

ratio

Baseline, Week 12, 24, 52

ID	Title	Description
OG000	Treatment Period: Placebo	Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
OG001	Treatment Period: Bococizumab 150 mg	Participants received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.

Units	Counts
Participants	OG000

Secondary

Absolute Change From Baseline in Ratio of Fasting Apolipoprotein B (ApoB) to Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52

FAS included all participants who were randomized. Here, "n" signifies number of participants evaluable at specified time points.

Posted

Mean

Standard Deviation

ratio

Baseline, Week 12, 24, 52

ID	Title	Description
OG000	Treatment Period: Placebo	Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
OG001	Treatment Period: Bococizumab 150 mg	Participants received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 100 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52

FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm respectively.

Posted

Number

percentage of participants

Week 12, 24, 52

ID	Title	Description
OG000	Treatment Period: Placebo	Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
OG001	Treatment Period: Bococizumab 150 mg	Participants received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 70 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52

FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm respectively.

Posted

Number

percentage of participants

Week 12, 24, 52

ID	Title	Description
OG000	Treatment Period: Placebo	Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
OG001	Treatment Period: Bococizumab 150 mg	Participants received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.

Units	Counts
Participants	OG000

Secondary

Plasma Concentration Versus Time Summary of PF-04950615

Analysis set included participants who received at least 1 dose of PF-04950615. This outcome measure was planned not to be analysed for placebo reporting arm. Here, "n" signifies those participants who were evaluable at specified time points.

Posted

Mean

Standard Deviation

microgram per milliliter

Week 12, 24, 52

ID	Title	Description
OG000	Treatment Period: Bococizumab 150 mg	Participants received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Adverse Events (AEs) Related to Type 1 and 3 Hypersensitivity Reactions and Injection Site Reactions

Type 1 hypersensitivity or allergic reactions were possible in response to any injected protein and included shortness of breath, urticaria, anaphylaxis and angioedema. Type 3 hypersensitivity reactions were similar to Type 1 hypersensitivity reactions but were likely to be delayed from the time of injection and included symptoms such as rash, urticaria, polyarthritis, myalgia's, polysynovitis, fever and if severe then included glomerulonephritis. Injection site reactions included injection site bruising, discolouration, erythema, haematoma, haemorrhage, nodule, induration, inflammation, mass, pain, paraesthesia, pruritus, swelling, vesicles, warmth, scab and rash. Participants with type 1 or type 3 hypersensitivity reactions and participants with injection site reactions were reported in this outcome measure.

Safety analysis set included all participants who received at least 1 dose of study treatment.

Posted

Number

Percentage of participants

Baseline up to end of study (up to 110 weeks)

ID	Title	Description
OG000	Treatment Period: Placebo	Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
OG001	Treatment Period: Bococizumab 150 mg	Participants received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.

Secondary

Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Treatment Period

Percentage of participants with at least 1 positive ADA titer or 1 positive nAb titer were reported. ADA titer >=6.23 (log 2) unit was considered to be ADA positive and nAb titer >=1.58 (log 2) unit was considered to be nAb positive.

Analysis set included all participants who received at least 1 dose of PF-04950615 150 mg. This outcome measure was planned not to be analysed for placebo reporting arm. Here "N" signifies number of subjects who were evaluable for this outcome measure.

Posted

Number

Percentage of participants

Baseline up to Week 58

ID	Title	Description
OG000	Treatment Period: Bococizumab 150 mg	Participants received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.

Units	Counts
Participants	OG000

Secondary

Number of Participants Who Changed Concomitant Medication During Extension Period

In this outcome measure, total number of participants who changed their lipid-lowering medications or added a monoclonal antibody medication during the extension period were reported.

All participants who consented for extension period.

Posted

Count of Participants

Participants

Week 58 follow-up to Week 110

ID	Title	Description
OG000	Extension Period: Placebo	Participants randomized to Placebo arm in treatment period and consented for extension period after Week 58 follow-up visit, were followed for SAEs and concomitant medications up to Week 110.
OG001	Extension Period: Bococizumab ADA Positive	Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their ADA assessment at Week 58 follow-up visit. In extension period, participants who were ADA positive and consented for extension period were assessed for ADA and LDL-C direct measurement until ADA titers were no longer detectable or had returned to baseline titer (less than or equal to 1.58 (log2) units above a positive baseline titer) or until Week 110 along with SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
OG002	Extension Period: Bococizumab ADA Negative

Secondary

Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 58 (Follow up), 71, 84, 97 and 110: Extension Period

All participants who consented for extension period. This outcome measure was planned not to be analyzed for reporting arms: Placebo (Extension Period) and Bococizumab ADA negative (Extension Period).

Posted

Mean

Standard Deviation

percent change

Baseline, Week 58 (follow up), 71, 84, 97, 110

ID	Title	Description
OG000	Extension Period: Bococizumab ADA Positive	Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their ADA assessment at Week 58 follow-up visit. In extension period, participants who were ADA positive and consented for extension period were assessed for ADA and LDL-C direct measurement until ADA titers were no longer detectable or had returned to baseline titer (less than or equal to 1.58 (log2) units above a positive baseline titer) or until Week 110 along with SAEs and concomitant medication, from Week 58 follow up visit to Week 110.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Extension Period

Percentage of participants with at least 1 positive ADA titer or 1 positive nAb titer were reported. ADA titer >=6.23 log2 unit was considered to be ADA positive and nAb titer >=1.58 log2 unit was considered to be nAb positive.

All participants who consented for extension period. This outcome measure was planned not to be analyzed for reporting arms Placebo (Extension period) and Bococizumab ADA negative (Extension period). Here, "n" signifies number of participants who were evaluable at specified time points.

Posted

Number

percentage of participants

Week 58 (follow-up), Week 71, Week 84, Week 97, Week 110

ID	Title	Description
OG000	Extension Period: Bococizumab ADA Positive	Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their ADA assessment at Week 58 follow-up visit. In extension period, participants who were ADA positive and consented for extension period were assessed for ADA and LDL-C direct measurement until ADA titers were no longer detectable or had returned to baseline titer (less than or equal to 1.58 (log2) units above a positive baseline titer) or until Week 110 along with SAEs and concomitant medication, from Week 58 follow up visit to Week 110.

Units	Counts

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
POSSIBLE SEIZURE DISORDER SECONDARY TO AMPHETAMINE ABUSE	General disorders	MedDRA 19.0	Non-systematic Assessment	EG0001 affected247 at risk EG0010 affected499 at risk EG0020 affected44 at risk EG0030 affected33 at risk EG004
Anaemia	Blood and lymphatic system disorders	MedDRA 19.0	Non-systematic Assessment	EG0001 affected247 at risk EG0010 affected499 at risk EG0020 affected44 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment	EG0002 affected247 at risk EG0010 affected499 at risk EG0020 affected44 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment	EG0001 affected247 at risk EG0013 affected499 at risk EG0020 affected44 at risk EG003
Angina unstable	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment	EG0002 affected247 at risk EG0014 affected499 at risk EG0020 affected44 at risk EG003
Arrhythmia	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment	EG0001 affected247 at risk EG0010 affected499 at risk EG0020 affected44 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected247 at risk EG0012 affected499 at risk EG0020 affected44 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment	EG0002 affected247 at risk EG0010 affected499 at risk EG0020 affected44 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected247 at risk EG0011 affected499 at risk EG0020 affected44 at risk EG003
Coronary artery occlusion	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected247 at risk EG0011 affected499 at risk EG0020 affected44 at risk EG003
Left ventricular failure	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected247 at risk EG0011 affected499 at risk EG0020 affected44 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment	EG0003 affected247 at risk EG0010 affected499 at risk EG0020 affected44 at risk EG003
Sinus bradycardia	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment	EG0001 affected247 at risk EG0010 affected499 at risk EG0020 affected44 at risk EG003
Sinus node dysfunction	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected247 at risk EG0011 affected499 at risk EG0020 affected44 at risk EG003
Ventricular tachycardia	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected247 at risk EG0011 affected499 at risk EG0020 affected44 at risk EG003
Sudden hearing loss	Ear and labyrinth disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected247 at risk EG0011 affected499 at risk EG0020 affected44 at risk EG003
Cataract	Eye disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected247 at risk EG0011 affected499 at risk EG0020 affected44 at risk EG003
Abdominal hernia	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected247 at risk EG0011 affected499 at risk EG0020 affected44 at risk EG003
Diverticulum intestinal	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected247 at risk EG0011 affected499 at risk EG0020 affected44 at risk EG003
Duodenal ulcer	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected247 at risk EG0011 affected499 at risk EG0020 affected44 at risk EG003
Gastric ulcer	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0002 affected247 at risk EG0010 affected499 at risk EG0020 affected44 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0001 affected247 at risk EG0010 affected499 at risk EG0020 affected44 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected247 at risk EG0011 affected499 at risk EG0020 affected44 at risk EG003
Oesophageal perforation	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0001 affected247 at risk EG0010 affected499 at risk EG0020 affected44 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected247 at risk EG0011 affected499 at risk EG0020 affected44 at risk EG003
Asthenia	General disorders	MedDRA 19.0	Non-systematic Assessment	EG0001 affected247 at risk EG0010 affected499 at risk EG0020 affected44 at risk EG003
Chest pain	General disorders	MedDRA 19.0	Non-systematic Assessment	EG0001 affected247 at risk EG0011 affected499 at risk EG0020 affected44 at risk EG003
Complication associated with device	General disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected247 at risk EG0011 affected499 at risk EG0020 affected44 at risk EG003
Death	General disorders	MedDRA 19.0	Non-systematic Assessment	EG0001 affected247 at risk EG0011 affected499 at risk EG0020 affected44 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected247 at risk EG0015 affected499 at risk EG0020 affected44 at risk EG003
Pyrexia	General disorders	MedDRA 19.0	Non-systematic Assessment	EG0001 affected247 at risk EG0010 affected499 at risk EG0020 affected44 at risk EG003
Vascular stent occlusion	General disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected247 at risk EG0011 affected499 at risk EG0020 affected44 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected247 at risk EG0011 affected499 at risk EG0020 affected44 at risk EG003
Arthritis bacterial	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	EG0001 affected247 at risk EG0010 affected499 at risk EG0020 affected44 at risk EG003
Diverticulitis	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	EG0000 affected247 at risk EG0011 affected499 at risk EG0020 affected44 at risk EG003
Gangrene	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	EG0001 affected247 at risk EG0010 affected499 at risk EG0020 affected44 at risk EG003
Infected skin ulcer	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	EG0001 affected247 at risk EG0010 affected499 at risk EG0020 affected44 at risk EG003
Klebsiella sepsis	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	EG0000 affected247 at risk EG0011 affected499 at risk EG0020 affected44 at risk EG003
Pneumonia	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	EG0001 affected247 at risk EG0012 affected499 at risk EG0020 affected44 at risk EG003
Postoperative wound infection	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	EG0001 affected247 at risk EG0010 affected499 at risk EG0020 affected44 at risk EG003
Sepsis	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	EG0001 affected247 at risk EG0010 affected499 at risk EG0020 affected44 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	EG0001 affected247 at risk EG0010 affected499 at risk EG0020 affected44 at risk EG003
Urosepsis	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	EG0000 affected247 at risk EG0011 affected499 at risk EG0020 affected44 at risk EG003
Arterial injury	Injury, poisoning and procedural complications	MedDRA 19.0	Non-systematic Assessment	EG0001 affected247 at risk EG0010 affected499 at risk EG0020 affected44 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA 19.0	Non-systematic Assessment	EG0001 affected247 at risk EG0010 affected499 at risk EG0020 affected44 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected247 at risk EG0011 affected499 at risk EG0020 affected44 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0001 affected247 at risk EG0010 affected499 at risk EG0020 affected44 at risk EG003
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected247 at risk EG0011 affected499 at risk EG0020 affected44 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected247 at risk EG0011 affected499 at risk EG0020 affected44 at risk EG003
Spondyloarthropathy	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected247 at risk EG0011 affected499 at risk EG0020 affected44 at risk EG003
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected247 at risk EG0011 affected499 at risk EG0020 affected44 at risk EG003
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Non-systematic Assessment	EG0001 affected247 at risk EG0010 affected499 at risk EG0020 affected44 at risk EG003
Bone cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Non-systematic Assessment	EG0001 affected247 at risk EG0010 affected499 at risk EG0020 affected44 at risk EG003
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Non-systematic Assessment	EG0001 affected247 at risk EG0010 affected499 at risk EG0020 affected44 at risk EG003
Breast cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Non-systematic Assessment	EG0001 affected247 at risk EG0010 affected499 at risk EG0020 affected44 at risk EG003
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Non-systematic Assessment	EG0000 affected247 at risk EG0011 affected499 at risk EG0020 affected44 at risk EG003
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Non-systematic Assessment	EG0001 affected247 at risk EG0011 affected499 at risk EG0020 affected44 at risk EG003
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Non-systematic Assessment	EG0000 affected247 at risk EG0011 affected499 at risk EG0020 affected44 at risk EG003
Skin cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Non-systematic Assessment	EG0001 affected247 at risk EG0010 affected499 at risk EG0020 affected44 at risk EG003
Tonsil cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Non-systematic Assessment	EG0000 affected247 at risk EG0011 affected499 at risk EG0020 affected44 at risk EG003
Cerebral haematoma	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected247 at risk EG0011 affected499 at risk EG0020 affected44 at risk EG003
Cerebral haemorrhage	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected247 at risk EG0011 affected499 at risk EG0020 affected44 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected247 at risk EG0013 affected499 at risk EG0020 affected44 at risk EG003
Ischaemic stroke	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected247 at risk EG0011 affected499 at risk EG0020 affected44 at risk EG003
Miller Fisher syndrome	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected247 at risk EG0011 affected499 at risk EG0020 affected44 at risk EG003
Radiculopathy	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected247 at risk EG0011 affected499 at risk EG0020 affected44 at risk EG003
Subarachnoid haemorrhage	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment	EG0001 affected247 at risk EG0010 affected499 at risk EG0020 affected44 at risk EG003
Syncope	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment	EG0001 affected247 at risk EG0012 affected499 at risk EG0020 affected44 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected247 at risk EG0011 affected499 at risk EG0020 affected44 at risk EG003
Depression	Psychiatric disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected247 at risk EG0011 affected499 at risk EG0020 affected44 at risk EG003
Depression suicidal	Psychiatric disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected247 at risk EG0011 affected499 at risk EG0020 affected44 at risk EG003
Paranoia	Psychiatric disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected247 at risk EG0011 affected499 at risk EG0020 affected44 at risk EG003
Psychiatric decompensation	Psychiatric disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected247 at risk EG0011 affected499 at risk EG0020 affected44 at risk EG003
Suicidal behaviour	Psychiatric disorders	MedDRA 19.0	Non-systematic Assessment	EG0001 affected247 at risk EG0010 affected499 at risk EG0020 affected44 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 19.0	Non-systematic Assessment	EG0001 affected247 at risk EG0010 affected499 at risk EG0020 affected44 at risk EG003
Chronic kidney disease	Renal and urinary disorders	MedDRA 19.0	Non-systematic Assessment	EG0001 affected247 at risk EG0010 affected499 at risk EG0020 affected44 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected247 at risk EG0011 affected499 at risk EG0020 affected44 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA 19.0	Non-systematic Assessment	EG0001 affected247 at risk EG0011 affected499 at risk EG0020 affected44 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected247 at risk EG0011 affected499 at risk EG0020 affected44 at risk EG003
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0001 affected247 at risk EG0010 affected499 at risk EG0020 affected44 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0001 affected247 at risk EG0010 affected499 at risk EG0020 affected44 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected247 at risk EG0012 affected499 at risk EG0020 affected44 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected247 at risk EG0011 affected499 at risk EG0020 affected44 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected247 at risk EG0011 affected499 at risk EG0020 affected44 at risk EG003
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0001 affected247 at risk EG0010 affected499 at risk EG0020 affected44 at risk EG003
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected247 at risk EG0011 affected499 at risk EG0020 affected44 at risk EG003
Aortic aneurysm	Vascular disorders	MedDRA 19.0	Non-systematic Assessment	EG0001 affected247 at risk EG0010 affected499 at risk EG0020 affected44 at risk EG003
Peripheral artery dissection	Vascular disorders	MedDRA 19.0	Non-systematic Assessment	EG0001 affected247 at risk EG0010 affected499 at risk EG0020 affected44 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA v20.0J	Non-systematic Assessment	EG0000 affected247 at risk EG0010 affected499 at risk EG0020 affected44 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA v20.0J	Non-systematic Assessment	EG0000 affected247 at risk EG0010 affected499 at risk EG0021 affected44 at risk EG003
Chest pain	Respiratory, thoracic and mediastinal disorders	MedDRA v20.0J	Non-systematic Assessment	EG0000 affected247 at risk EG0010 affected499 at risk EG0020 affected44 at risk EG003
Myocardial ischaemia	Cardiac disorders	MedDRA v20.0J	Non-systematic Assessment	EG0000 affected247 at risk EG0010 affected499 at risk EG0021 affected44 at risk EG003
Disease progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v20.0J	Non-systematic Assessment	EG0000 affected247 at risk EG0010 affected499 at risk EG0021 affected44 at risk EG003

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

ID	Title	Description
BG000	Treatment Period: Placebo	Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
BG001	Treatment Period: Bococizumab 150 mg	Participants received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
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	Treatment Period: Placebo	Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	2	247	32	247	29	247
EG001	Treatment Period: Bococizumab 150 mg	Participants received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.	2	499	44	499	97	499
EG002	Extension Period: Placebo	Participants randomized to Placebo arm in treatment period and consented for extension period after Week 58 follow-up visit, were followed for SAEs and concomitant medications up to Week 110.	0	44	2	44	0	0
EG003	Extension Period: Bococizumab ADA Positive	Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their ADA assessment at Week 58 follow-up visit. In extension period, participants who were ADA positive and consented for extension period were assessed for ADA and LDL-C direct measurement until ADA titers were no longer detectable or had returned to baseline titer (less than or equal to 1.58 (log2) units above a positive baseline titer) or until Week 110 along with SAEs and concomitant medication, from Week 58 follow up visit to Week 110.	0	33	0	33	0	0
EG004	Extension Period: Bococizumab ADA Negative	Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.	0	56	1	56	0	0

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Injection site reaction	General disorders	MedDRA 19.0	Non-systematic Assessment	EG0002 affected247 at risk EG00167 affected499 at risk EG0020 affected0 at risk EG0030 affected0 at risk EG0040 affected0 at risk
Nasopharyngitis	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	EG00014 affected247 at risk EG00117 affected499 at risk EG0020 affected0 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	EG00014 affected247 at risk EG00118 affected499 at risk EG0020 affected0 at risk EG003