Randomized Clinical Trial of Bococizumab (PF-04950615; RN... | NCT01968967

ID	Type	Description	Link
2013-002643-28	EudraCT Number
SPIRE-LDL	Other Identifier	Alias Study Number

Label	Type	Description	Intervention Names
Bococizumab (PF-04950615; RN316)	Experimental		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, 12 months	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
Ernest L. Hendrix, MD, PC		Athens	Alabama	35611	United States
North Alabama Research Center, LLC

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	Placebo (Treatment Period)	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	Bococizumab 150 mg (Treatment Period)

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	Placebo (Treatment Period)	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	Bococizumab 150 mg (Treatment Period)	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	OG000994 OG001980

Title

Denominators

Categories

Title	Measurements
	OG0001.0± 22.55 OG001-54.9± 26.84

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 percent (%) confidence interval (CI), and p-value were derived from 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	-56.2	Standard Error of the Mean	1.10	2-Sided	95	-58.3	-54.0					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	Placebo (Treatment Period)	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	Bococizumab 150 mg (Treatment Period)	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	Placebo (Treatment Period)	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	Bococizumab 150 mg (Treatment Period)	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 (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	Placebo (Treatment Period)	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	Bococizumab 150 mg (Treatment Period)	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 (TG) 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 evaluable at specified time points.

Posted

Mean

Standard Deviation

percent change

Baseline, Week 12, 24, 52

ID	Title	Description
OG000	Placebo (Treatment Period)	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	Bococizumab 150 mg (Treatment Period)	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	Placebo (Treatment Period)	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	Bococizumab 150 mg (Treatment Period)	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	Placebo (Treatment Period)	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	Bococizumab 150 mg (Treatment Period)	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	Placebo (Treatment Period)	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	Bococizumab 150 mg (Treatment Period)	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 for this outcome measure.

Posted

Mean

Standard Deviation

percent change

Baseline, Week 24, 52

ID	Title	Description
OG000	Placebo (Treatment Period)	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	Bococizumab 150 mg (Treatment Period)	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	Placebo (Treatment Period)	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	Bococizumab 150 mg (Treatment Period)	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	Placebo (Treatment Period)	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	Bococizumab 150 mg (Treatment Period)	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	Placebo (Treatment Period)	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	Bococizumab 150 mg (Treatment Period)	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	Placebo (Treatment Period)	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	Bococizumab 150 mg (Treatment Period)	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	Placebo (Treatment Period)	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	Bococizumab 150 mg (Treatment Period)	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	Placebo (Treatment Period)	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	Bococizumab 150 mg (Treatment Period)	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	Placebo (Treatment Period)	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	Bococizumab 150 mg (Treatment Period)	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	Placebo (Treatment Period)	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	Bococizumab 150 mg (Treatment Period)	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 (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	Placebo (Treatment Period)	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	Bococizumab 150 mg (Treatment Period)	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	Placebo (Treatment Period)	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	Bococizumab 150 mg (Treatment Period)	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	Placebo (Treatment Period)	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	Bococizumab 150 mg (Treatment Period)	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	Placebo (Treatment Period)	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	Bococizumab 150 mg (Treatment Period)	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	Placebo (Treatment Period)	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	Bococizumab 150 mg (Treatment Period)	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

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	Placebo (Treatment Period)	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	Bococizumab 150 mg (Treatment Period)	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	Placebo (Treatment Period)	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	Bococizumab 150 mg (Treatment Period)	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	Placebo (Treatment Period)	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	Bococizumab 150 mg (Treatment Period)	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 of PF-04950615 at Week 12, 24 and 52

Plasma concentration of PF-04950615 at Week 12, 24 and 52 was reported.

Analysis set included participants who received at least 1 dose of PF-04950615. 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	Bococizumab 150 mg (Treatment Period)	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 With Adverse Events (AEs) Related to Type 1 or 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

Count of Participants

Participants

Baseline up to Week 58

ID	Title	Description
OG000	Placebo (Treatment Period)	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	Bococizumab 150 mg (Treatment Period)	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 (log2) unit was considered to be ADA positive and nAb titer >=1.58 (log2) unit was considered to be nAb positive.

Safety analysis population included all participants who received at least 1 dose of study treatment. Here, "N" signifies those participants who were evaluable for this outcome measure for each reporting arm respectively.

Posted

Number

Percentage of participants

Baseline up to Week 58

ID	Title	Description
OG000	Placebo (Treatment Period)	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	Bococizumab 150 mg (Treatment Period)	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

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 visit to Week 110

ID	Title	Description
OG000	Placebo (Extension Period)	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	Bococizumab ADA Positive (Extension Period)	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	Bococizumab ADA Negative (Extension Period)

Secondary

Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 58 Follow-up Visit, 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). Here, "n" signifies number of participants who were evaluable at specified time points.

Posted

Mean

Standard Deviation

percent change

Baseline, Week 58 follow-up visit, 71, 84, 97, 110

ID	Title	Description
OG000	Bococizumab ADA Positive (Extension Period)	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

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 visit, Week 71, Week 84, Week 97, Week 110

ID	Title	Description
OG000	Bococizumab ADA Positive (Extension Period)	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	Notes	Statistical Information
Left leg - severe pain, redness, and induration	General disorders	MedDRA 19.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG0030 affected19 at risk EG004
Leukocytosis	Blood and lymphatic system disorders	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Acute coronary syndrome	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0017 affected1,063 at risk EG0020 affected47 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment		EG0004 affected1,065 at risk EG0018 affected1,063 at risk EG0020 affected47 at risk EG003
Angina unstable	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment		EG0006 affected1,065 at risk EG0012 affected1,063 at risk EG0020 affected47 at risk EG003
Aortic valve calcification	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Aortic valve stenosis	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Arteriospasm coronary	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment		EG0004 affected1,065 at risk EG0014 affected1,063 at risk EG0020 affected47 at risk EG003
Atrial flutter	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Atrioventricular block	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Bradycardia	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0012 affected1,063 at risk EG0020 affected47 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0012 affected1,063 at risk EG0020 affected47 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment		EG0003 affected1,065 at risk EG0014 affected1,063 at risk EG0020 affected47 at risk EG003
Cardio-respiratory arrest	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Cardiomyopathy	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Cardiorenal syndrome	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment		EG0004 affected1,065 at risk EG0013 affected1,063 at risk EG0020 affected47 at risk EG003
Coronary artery occlusion	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Hypertensive heart disease	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Mitral valve incompetence	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment		EG0002 affected1,065 at risk EG0014 affected1,063 at risk EG0020 affected47 at risk EG003
Myocardial ischaemia	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0013 affected1,063 at risk EG0020 affected47 at risk EG003
Subvalvular aortic stenosis	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Ventricular extrasystoles	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Ventricular tachycardia	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0012 affected1,063 at risk EG0020 affected47 at risk EG003
Bartter's syndrome	Congenital, familial and genetic disorders	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA 19.0	Non-systematic Assessment		EG0002 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Vertigo positional	Ear and labyrinth disorders	MedDRA 19.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Cataract	Eye disorders	MedDRA 19.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Abdominal hernia	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment		EG0004 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment		EG0002 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Colitis ulcerative	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Food poisoning	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment		EG0002 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment		EG0002 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Oesophageal ulcer	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Peptic ulcer haemorrhage	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Salivary gland calculus	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Volvulus	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Asthenia	General disorders	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Chest pain	General disorders	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Death	General disorders	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Impaired healing	General disorders	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 19.0	Non-systematic Assessment		EG0003 affected1,065 at risk EG0017 affected1,063 at risk EG0020 affected47 at risk EG003
Oedema peripheral	General disorders	MedDRA 19.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Peripheral swelling	General disorders	MedDRA 19.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Biliary colic	Hepatobiliary disorders	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA 19.0	Non-systematic Assessment		EG0002 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Jaundice cholestatic	Hepatobiliary disorders	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Appendicitis	Infections and infestations	MedDRA 19.0	Non-systematic Assessment		EG0002 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Appendicitis perforated	Infections and infestations	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Arthritis bacterial	Infections and infestations	MedDRA 19.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Bronchitis	Infections and infestations	MedDRA 19.0	Non-systematic Assessment		EG0002 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Cellulitis	Infections and infestations	MedDRA 19.0	Non-systematic Assessment		EG0005 affected1,065 at risk EG0014 affected1,063 at risk EG0020 affected47 at risk EG003
Cellulitis of male external genital organ	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	This event was gender specific.	EG0001 affected635 at risk EG0010 affected630 at risk EG0020 affected31 at risk EG003
Device related infection	Infections and infestations	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Diabetic gangrene	Infections and infestations	MedDRA 19.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Diverticulitis	Infections and infestations	MedDRA 19.0	Non-systematic Assessment		EG0002 affected1,065 at risk EG0012 affected1,063 at risk EG0020 affected47 at risk EG003
Escherichia sepsis	Infections and infestations	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0012 affected1,063 at risk EG0020 affected47 at risk EG003
Localised infection	Infections and infestations	MedDRA 19.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Osteomyelitis	Infections and infestations	MedDRA 19.0	Non-systematic Assessment		EG0003 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Otitis externa	Infections and infestations	MedDRA 19.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Pneumonia	Infections and infestations	MedDRA 19.0	Non-systematic Assessment		EG00010 affected1,065 at risk EG0013 affected1,063 at risk EG0020 affected47 at risk EG003
Pneumonia bacterial	Infections and infestations	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Pyelonephritis acute	Infections and infestations	MedDRA 19.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Scrotal abscess	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	This event was gender specific.	EG0001 affected635 at risk EG0010 affected630 at risk EG0020 affected31 at risk EG003
Sepsis	Infections and infestations	MedDRA 19.0	Non-systematic Assessment		EG0002 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Sepsis syndrome	Infections and infestations	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Septic shock	Infections and infestations	MedDRA 19.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0012 affected1,063 at risk EG0020 affected47 at risk EG003
Sialoadenitis	Infections and infestations	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Skin infection	Infections and infestations	MedDRA 19.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Staphylococcal infection	Infections and infestations	MedDRA 19.0	Non-systematic Assessment		EG0002 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 19.0	Non-systematic Assessment		EG0003 affected1,065 at risk EG0014 affected1,063 at risk EG0020 affected47 at risk EG003
Anastomotic ulcer haemorrhage	Injury, poisoning and procedural complications	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Burns second degree	Injury, poisoning and procedural complications	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 19.0	Non-systematic Assessment		EG0003 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0012 affected1,063 at risk EG0020 affected47 at risk EG003
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Non-systematic Assessment		EG0002 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Intentional overdose	Injury, poisoning and procedural complications	MedDRA 19.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Laceration	Injury, poisoning and procedural complications	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Muscle injury	Injury, poisoning and procedural complications	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Nerve injury	Injury, poisoning and procedural complications	MedDRA 19.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Overdose	Injury, poisoning and procedural complications	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Radius fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 19.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Ulna fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Vascular graft occlusion	Injury, poisoning and procedural complications	MedDRA 19.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Vascular graft thrombosis	Injury, poisoning and procedural complications	MedDRA 19.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Blood creatinine increased	Investigations	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Blood pressure increased	Investigations	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Blood urine present	Investigations	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Electrocardiogram QT prolonged	Investigations	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Electrocardiogram change	Investigations	MedDRA 19.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA 19.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Hepatic enzyme increased	Investigations	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Liver function test increased	Investigations	MedDRA 19.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Troponin increased	Investigations	MedDRA 19.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 19.0	Non-systematic Assessment		EG0002 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0012 affected1,063 at risk EG0020 affected47 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0012 affected1,063 at risk EG0020 affected47 at risk EG003
Obesity	Metabolism and nutrition disorders	MedDRA 19.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0012 affected1,063 at risk EG0020 affected47 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Non-systematic Assessment		EG0003 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Intervertebral disc disorder	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Non-systematic Assessment		EG0002 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Non-systematic Assessment		EG0003 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Metatarsalgia	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Neck mass	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0014 affected1,063 at risk EG0020 affected47 at risk EG003
Polymyalgia rheumatica	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Non-systematic Assessment		EG0002 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Non-systematic Assessment		EG0002 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Endometrial adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Non-systematic Assessment	This event was gender specific.	EG0000 affected430 at risk EG0011 affected433 at risk EG0020 affected16 at risk EG003
Endometrial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Non-systematic Assessment	This event was gender specific.	EG0000 affected430 at risk EG0011 affected433 at risk EG0020 affected16 at risk EG003
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Glioblastoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Metastases to spine	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Metastatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Ovarian cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Non-systematic Assessment	This event was gender specific.	EG0001 affected430 at risk EG0010 affected433 at risk EG0020 affected16 at risk EG003
Papillary thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Non-systematic Assessment	This event was gender specific.	EG0003 affected635 at risk EG0010 affected630 at risk EG0020 affected31 at risk EG003
Schwannoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Transitional cell carcinoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Uterine cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Non-systematic Assessment	This event was gender specific.	EG0002 affected430 at risk EG0010 affected433 at risk EG0020 affected16 at risk EG003
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Non-systematic Assessment	This event was gender specific.	EG0000 affected430 at risk EG0011 affected433 at risk EG0020 affected16 at risk EG003
Aphasia	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Carotid arteriosclerosis	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment		EG0003 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Cervical myelopathy	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Dizziness	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Embolic stroke	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Facial paralysis	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Ischaemic stroke	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment		EG0002 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Lacunar infarction	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Loss of consciousness	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Mental impairment	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Myelopathy	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Presyncope	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Radiculopathy	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Seizure	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0013 affected1,063 at risk EG0020 affected47 at risk EG003
Syncope	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment		EG0008 affected1,065 at risk EG0012 affected1,063 at risk EG0020 affected47 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Delirium	Psychiatric disorders	MedDRA 19.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Depression	Psychiatric disorders	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0012 affected1,063 at risk EG0020 affected47 at risk EG003
Drug dependence	Psychiatric disorders	MedDRA 19.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Schizoaffective disorder	Psychiatric disorders	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Suicide attempt	Psychiatric disorders	MedDRA 19.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 19.0	Non-systematic Assessment		EG0002 affected1,065 at risk EG0013 affected1,063 at risk EG0020 affected47 at risk EG003
Chronic kidney disease	Renal and urinary disorders	MedDRA 19.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA 19.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0012 affected1,063 at risk EG0020 affected47 at risk EG003
Renal colic	Renal and urinary disorders	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Renal mass	Renal and urinary disorders	MedDRA 19.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Ureteric obstruction	Renal and urinary disorders	MedDRA 19.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Urethral stenosis	Renal and urinary disorders	MedDRA 19.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Prostatic haemorrhage	Reproductive system and breast disorders	MedDRA 19.0	Non-systematic Assessment	This event was gender specific.	EG0000 affected635 at risk EG0011 affected630 at risk EG0020 affected31 at risk EG003
Scrotal ulcer	Reproductive system and breast disorders	MedDRA 19.0	Non-systematic Assessment	This event was gender specific.	EG0001 affected635 at risk EG0010 affected630 at risk EG0020 affected31 at risk EG003
Vaginal prolapse	Reproductive system and breast disorders	MedDRA 19.0	Non-systematic Assessment	This event was gender specific.	EG0001 affected430 at risk EG0010 affected433 at risk EG0020 affected16 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment		EG0003 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment		EG0002 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment		EG0006 affected1,065 at risk EG0012 affected1,063 at risk EG0020 affected47 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment		EG0002 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Aortic stenosis	Vascular disorders	MedDRA 19.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Haematoma	Vascular disorders	MedDRA 19.0	Non-systematic Assessment		EG0004 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Hypotension	Vascular disorders	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Hypovolaemic shock	Vascular disorders	MedDRA 19.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Intermittent claudication	Vascular disorders	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Orthostatic hypotension	Vascular disorders	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 19.0	Non-systematic Assessment		EG0002 affected1,065 at risk EG0012 affected1,063 at risk EG0020 affected47 at risk EG003
Peripheral ischaemia	Vascular disorders	MedDRA 19.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Peripheral vascular disorder	Vascular disorders	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Vena cava thrombosis	Vascular disorders	MedDRA 19.0	Non-systematic Assessment		EG0001 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Venous thrombosis limb	Vascular disorders	MedDRA 19.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0011 affected1,063 at risk EG0020 affected47 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA 20.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0010 affected1,063 at risk EG0021 affected47 at risk EG003
Condition aggravated	Cardiac disorders	MedDRA 20.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0010 affected1,063 at risk EG0021 affected47 at risk EG003
Pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Non-systematic Assessment		EG0000 affected1,065 at risk EG0010 affected1,063 at risk EG0020 affected47 at risk EG003

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

ID	Title	Description
BG000	Placebo (Treatment Period)	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	Bococizumab 150 mg (Treatment Period)	Participants received Bococizumab (PF--04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52 and 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	Placebo (Treatment Period)	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.	9	1,065	150	1,065	138	1,065
EG001	Bococizumab 150 mg (Treatment Period)	Participants received Bococizumab (PF--04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52 and were followed up to Week 58.	2	1,063	116	1,063	177	1,063
EG002	Placebo (Extension Period)	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	47	1	47	0	0
EG003	Bococizumab ADA Positive (Extension Period)	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	19	1	19	0	0
EG004	Bococizumab ADA Negative (Extension Period)	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	39	1	39	0	0

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Injection site reaction	General disorders	MedDRA 19.0	Non-systematic Assessment	EG00023 affected1,065 at risk EG00197 affected1,063 at risk EG0020 affected0 at risk EG0030 affected0 at risk EG0040 affected0 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	EG00060 affected1,065 at risk EG00150 affected1,063 at risk EG0020 affected0 at risk EG003
Hypertension	Vascular disorders	MedDRA 19.0	Non-systematic Assessment	EG00061 affected1,065 at risk EG00147 affected1,063 at risk EG0020 affected0 at risk EG003