Pharmacokinetics And Relative Bioavailability Of Bococizu... | NCT02043301

Label	Type	Intervention Names
Single 150 mg PF-04950615 dose administered to the abdomen	Active Comparator	Biological: Bococizumab (PF-04950615; RN316)
Single 150 mg PF-04950615 dose administered to the upper arm	Experimental	Biological: Bococizumab (PF-04950615; RN316)
Single 150 mg PF-04950615 dose administered to the thigh	Experimental	Biological: Bococizumab (PF-04950615; RN316)

Name	Type	Description	Arm Group Labels	Other Names
Bococizumab (PF-04950615; RN316)	Biological	Single 150 mg PF-04950615 dose administered SC to the abdomen	Single 150 mg PF-04950615 dose administered to the abdomen

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinite Time (AUCinf)	AUCinf is the area under the plasma concentration-time curve (AUC) from time zero (pre-dose) extrapolated to infinite time.	Day 1 (Hour 0 pre-dose, Hours 1 and 8 post-dose), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early Termination.
Maximum Observed Plasma Concentration (Cmax)	Maximum observed concentration.	Day 1 (Hour 0 pre-dose, Hours 1 and 8 post-dose), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early Termination.

Secondary Outcomes

Measure	Description	Time Frame
Area Under the Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast)	AUClast is area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration.	Day 1 (Hour 0 pre-dose, Hours 1 and 8 post-dose), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early Termination.

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

Facility	Status	City	State	ZIP	Country	Contacts
Anaheim Clinical Trials, LLC		Anaheim	California	92801	United States
Miami Research Associates

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.
28636184

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

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Bococizumab 150 mg Abdomen	Participants received a single dose of bococizumab 150 mg SC to the abdomen.
FG001	Bococizumab 150 mg Thigh	Participants received a single dose of bococizumab 150 mg SC to the thigh.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

ID	Title	Description
BG000	Bococizumab 150 mg Abdomen	Participants received a single dose of bococizumab 150 mg SC to the abdomen.
BG001	Bococizumab 150 mg Thigh	Participants received a single dose of bococizumab 150 mg SC to the thigh.
BG002	Bococizumab 150 mg Upper Arm	Participants received a single dose of bococizumab 150 mg SC to the upper arm.
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG00025 BG00125 BG00225 BG00375

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

Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinite Time (AUCinf)

AUCinf is the area under the plasma concentration-time curve (AUC) from time zero (pre-dose) extrapolated to infinite time.

The pharmacokinetic (PK) parameter analysis population included all enrolled participants who received at least 1 dose of study medication and that had at least 1 of the PK parameters of interest. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

Posted

Geometric Mean

Geometric Coefficient of Variation

micrograms*day/milliliter (mcg*day/mL)

Day 1 (Hour 0 pre-dose, Hours 1 and 8 post-dose), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early Termination.

ID	Title	Description
OG000	Bococizumab 150 mg Abdomen	Participants received a single dose of bococizumab 150 mg SC to the abdomen.
OG001	Bococizumab 150 mg Thigh	Participants received a single dose of bococizumab 150 mg SC to the thigh.
OG002	Bococizumab 150 mg Upper Arm	Participants received a single dose of bococizumab 150 mg SC to the upper arm.

Units	Counts
Participants	OG00024 OG00125 OG00225

Title

Denominators

Categories

Title	Measurements
	OG000175.9± 53 OG001198.9± 30 OG002160.3± 33

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	Thigh (Test) versus Abdomen (Reference)	ANCOVA	ANCOVA model with treatment group as a fixed effect and log-transformed body weight as a covariate.			Adjusted Geometric Means Ratio (%)	120.96			2-Sided	90	101.99	143.45					Superiority or Other	Ratios (and 90% confidence intervals) were expressed as percentages.

Primary

Maximum Observed Plasma Concentration (Cmax)

Maximum observed concentration.

The PK parameter analysis population included all enrolled participants who received at least 1 dose of study medication and that had at least 1 of the PK parameters of interest.

Posted

Geometric Mean

Geometric Coefficient of Variation

mcg/mL

Day 1 (Hour 0 pre-dose, Hours 1 and 8 post-dose), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early Termination.

ID	Title	Description
OG000	Bococizumab 150 mg Abdomen	Participants received a single dose of bococizumab 150 mg SC to the abdomen.
OG001	Bococizumab 150 mg Thigh	Participants received a single dose of bococizumab 150 mg SC to the thigh.
OG002	Bococizumab 150 mg Upper Arm	Participants received a single dose of bococizumab 150 mg SC to the upper arm.

Units	Counts

Secondary

Area Under the Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast)

AUClast is area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration.

The PK parameter analysis population included all enrolled participants who received at least 1 dose of study medication and that had at least 1 of the PK parameters of interest.

Posted

Geometric Mean

Geometric Coefficient of Variation

mcg*day/mL

Day 1 (Hour 0 pre-dose, Hours 1 and 8 post-dose), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early Termination.

ID	Title	Description
OG000	Bococizumab 150 mg Abdomen	Participants received a single dose of bococizumab 150 mg SC to the abdomen.
OG001	Bococizumab 150 mg Thigh	Participants received a single dose of bococizumab 150 mg SC to the thigh.
OG002	Bococizumab 150 mg Upper Arm	Participants received a single dose of bococizumab 150 mg SC to the upper arm.

Secondary

Time to Reach Maximum Observed Plasma Concentration (Tmax)

Time for maximum observed concentration.

The PK parameter analysis population included all enrolled participants who received at least 1 dose of study medication and that had at least 1 of the PK parameters of interest.

Posted

Median

Full Range

days

Day 1 (Hour 0 pre-dose, Hours 1 and 8 post-dose), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early Termination.

ID	Title	Description
OG000	Bococizumab 150 mg Abdomen	Participants received a single dose of bococizumab 150 mg SC to the abdomen.
OG001	Bococizumab 150 mg Thigh	Participants received a single dose of bococizumab 150 mg SC to the thigh.
OG002	Bococizumab 150 mg Upper Arm	Participants received a single dose of bococizumab 150 mg SC to the upper arm.

Units	Counts

Secondary

Apparent Clearance (CL/F)

Apparent clearance following subcutaneous administration.

The PK parameter analysis population included all enrolled participants who received at least 1 dose of study medication and that had at least 1 of the PK parameters of interest. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

Posted

Geometric Mean

Geometric Coefficient of Variation

liters per day

Day 1 (Hour 0 pre-dose, Hours 1 and 8 post-dose), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early Termination.

ID	Title	Description
OG000	Bococizumab 150 mg Abdomen	Participants received a single dose of bococizumab 150 mg SC to the abdomen.
OG001	Bococizumab 150 mg Thigh	Participants received a single dose of bococizumab 150 mg SC to the thigh.
OG002	Bococizumab 150 mg Upper Arm	Participants received a single dose of bococizumab 150 mg SC to the upper arm.

Secondary

Apparent Volume of Distribution (Vz/F)

Apparent volume of distribution following subcutaneous administration.

Posted

Geometric Mean

Geometric Coefficient of Variation

liters

Day 1 (Hour 0 pre-dose, Hours 1 and 8 post-dose), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early Termination.

ID	Title	Description
OG000	Bococizumab 150 mg Abdomen	Participants received a single dose of bococizumab 150 mg SC to the abdomen.
OG001	Bococizumab 150 mg Thigh	Participants received a single dose of bococizumab 150 mg SC to the thigh.
OG002	Bococizumab 150 mg Upper Arm	Participants received a single dose of bococizumab 150 mg SC to the upper arm.

Secondary

Terminal Elimination Half-Life (t1/2)

Terminal elimination half-life following subcutaneous administration.

Posted

Mean

Standard Deviation

days

Day 1 (Hour 0 pre-dose, Hours 1 and 8 post-dose), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early Termination.

ID	Title	Description
OG000	Bococizumab 150 mg Abdomen	Participants received a single dose of bococizumab 150 mg SC to the abdomen.
OG001	Bococizumab 150 mg Thigh	Participants received a single dose of bococizumab 150 mg SC to the thigh.
OG002	Bococizumab 150 mg Upper Arm	Participants received a single dose of bococizumab 150 mg SC to the upper arm.

Secondary

Maximum Low-density Lipoprotein Cholesterol LDL-C Lowering Effect (Emax): Absolute Value

Maximum LDL-C response using absolute on trial LDL-C data

The pharmacodynamic (PD) analysis population included all enrolled participants who received at least 1 dose of study medication and had both baseline and post-baseline values for at least 1 of the PD endpoints.

Posted

Mean

Standard Deviation

mg/dL

Baseline (average of Day -7 and Day 1), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early Termination

ID	Title	Description
OG000	Bococizumab 150 mg Abdomen	Participants received a single dose of bococizumab 150 mg SC to the abdomen.
OG001	Bococizumab 150 mg Thigh	Participants received a single dose of bococizumab 150 mg SC to the thigh.
OG002	Bococizumab 150 mg Upper Arm	Participants received a single dose of bococizumab 150 mg SC to the upper arm.

Units

Secondary

Emax: Change From Baseline

LDL-C Emax expressed as change from baseline.

The PD analysis population included all enrolled participants who received at least 1 dose of study medication and had both baseline and post-baseline values for at least 1 of the PD endpoints.

Posted

Mean

Standard Deviation

mg/dL

Baseline (average of Day -7 and Day 1), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early Termination

ID	Title	Description
OG000	Bococizumab 150 mg Abdomen	Participants received a single dose of bococizumab 150 mg SC to the abdomen.
OG001	Bococizumab 150 mg Thigh	Participants received a single dose of bococizumab 150 mg SC to the thigh.
OG002	Bococizumab 150 mg Upper Arm	Participants received a single dose of bococizumab 150 mg SC to the upper arm.

Units	Counts

Secondary

Emax: Percent Change From Baseline

LDL-C Emax expressed as percent change from baseline.

The PD analysis population included all enrolled participants who received at least 1 dose of study medication and had both baseline and post-baseline values for at least 1 of the PD endpoints.

Posted

Mean

Standard Deviation

percent change

Baseline (average of Day -7 and Day 1), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early Termination

ID	Title	Description
OG000	Bococizumab 150 mg Abdomen	Participants received a single dose of bococizumab 150 mg SC to the abdomen.
OG001	Bococizumab 150 mg Thigh	Participants received a single dose of bococizumab 150 mg SC to the thigh.
OG002	Bococizumab 150 mg Upper Arm	Participants received a single dose of bococizumab 150 mg SC to the upper arm.

Units	Counts

Secondary

Time to Reach Maximum LDL-C Lowering (Tmax, LDL-C)

Time to LDL-C Emax

The PD analysis population included all enrolled participants who received at least 1 dose of study medication and had both baseline and post-baseline values for at least 1 of the PD endpoints.

Posted

Median

Full Range

days

Baseline (average of Day -7 and Day 1), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early Termination

ID	Title	Description
OG000	Bococizumab 150 mg Abdomen	Participants received a single dose of bococizumab 150 mg SC to the abdomen.
OG001	Bococizumab 150 mg Thigh	Participants received a single dose of bococizumab 150 mg SC to the thigh.
OG002	Bococizumab 150 mg Upper Arm	Participants received a single dose of bococizumab 150 mg SC to the upper arm.

Units	Counts
Participants

Secondary

Area Under the LDL-C Effect Curve (AUEC): Absolute Value

AUEC is the area under the LDL-C concentration-time curve from baseline to Day 85 exprssed using absolute on trial value

The PD analysis population included all enrolled participants who received at least 1 dose of study medication and had both baseline and post-baseline values for at least 1 of the PD endpoints. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

Posted

Mean

Standard Deviation

mg*day/dL

Baseline (average of Day -7 and Day 1), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early Termination

ID	Title	Description
OG000	Bococizumab 150 mg Abdomen	Participants received a single dose of bococizumab 150 mg SC to the abdomen.
OG001	Bococizumab 150 mg Thigh	Participants received a single dose of bococizumab 150 mg SC to the thigh.
OG002	Bococizumab 150 mg Upper Arm	Participants received a single dose of bococizumab 150 mg SC to the upper arm.

Secondary

AUEC: Change From Baseline

AUEC is the area under the LDL-C concentration-time curve from baseline to Day 85 exprssed as change from baseline

Posted

Mean

Standard Deviation

mg*day/dL

Baseline (average of Day -7 and Day 1), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early Termination

ID	Title	Description
OG000	Bococizumab 150 mg Abdomen	Participants received a single dose of bococizumab 150 mg SC to the abdomen.
OG001	Bococizumab 150 mg Thigh	Participants received a single dose of bococizumab 150 mg SC to the thigh.
OG002	Bococizumab 150 mg Upper Arm	Participants received a single dose of bococizumab 150 mg SC to the upper arm.

Secondary

AUEC: Percent Change From Baseline

AUEC is the area under the LDL-C concentration-time curve from baseline to Day 85 expressed as percent change from baseline.

Posted

Mean

Standard Deviation

percent change

Baseline (average of Day -7 and Day 1), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early Termination

ID	Title	Description
OG000	Bococizumab 150 mg Abdomen	Participants received a single dose of bococizumab 150 mg SC to the abdomen.
OG001	Bococizumab 150 mg Thigh	Participants received a single dose of bococizumab 150 mg SC to the thigh.
OG002	Bococizumab 150 mg Upper Arm	Participants received a single dose of bococizumab 150 mg SC to the upper arm.

Secondary

Number of Participants With Injection Site Reactions (ISRs) by Severity

Acute injection site reactions (e.g, pain, pruritus, induration) were captured as adverse events (AEs). Intensity of the AE was described as mild (does not interfere with usual function), moderate (interferes to some extent with usual function), or severe (interferes significantly with participant's usual function).

The safety analysis population included all participants who received at least 1 dose of study medication.

Posted

Number

participants

Day 1 to Day 85

ID	Title	Description
OG000	Bococizumab 150 mg Abdomen	Participants received a single dose of bococizumab 150 mg SC to the abdomen.
OG001	Bococizumab 150 mg Thigh	Participants received a single dose of bococizumab 150 mg SC to the thigh.
OG002	Bococizumab 150 mg Upper Arm	Participants received a single dose of bococizumab 150 mg SC to the upper arm.

Units	Counts

Secondary

Number of Participants With Positive Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb)

A participant is ADA positive if ADA titer (log2) >=6.23. A participant is nAb positive if nAb titer (log2) >=4.32.

The safety analysis population included all participants who received at least 1 dose of study medication.

Posted

Number

participants

Day 1, Day 15, Day 29, Day 57 and Day 85/Early Termination

ID	Title	Description
OG000	Bococizumab 150 mg Abdomen	Participants received a single dose of bococizumab 150 mg SC to the abdomen.
OG001	Bococizumab 150 mg Thigh	Participants received a single dose of bococizumab 150 mg SC to the thigh.
OG002	Bococizumab 150 mg Upper Arm	Participants received a single dose of bococizumab 150 mg SC to the upper arm.

Units	Counts
Participants

Secondary

Anti-Drug Antibody (ADA) Titer

ADA titer: titers were presented as log2 reciprocal dilution at assay cutpoint.

The safety analysis population included all participants who received at least 1 dose of study medication. Only confirmed ADA positive samples were analyzed for titer.

Posted

Median

Full Range

Log2 titer

Day 1, Day 15, Day 29, Day 57 and Day 85/Early Termination

ID	Title	Description
OG000	Bococizumab 150 mg Abdomen	Participants received a single dose of bococizumab 150 mg SC to the abdomen.
OG001	Bococizumab 150 mg Thigh	Participants received a single dose of bococizumab 150 mg SC to the thigh.
OG002	Bococizumab 150 mg Upper Arm	Participants received a single dose of bococizumab 150 mg SC to the upper arm.

Units	Counts
Participants

Secondary

Neutralizing Antibody (nAb) Titer

nAb titer: titers were presented as log2 reciprocal dilution at assay cutpoint.

The safety analysis population included all participants who received at least 1 dose of study medication. Only confirmed ADA positive samples were analyzed for nAb. nAb titer was determined if a sample is screened positive for nAb. nAb titer data for the Bococizumab 150 mg Upper Arm group is not presented as there were no nAb positive subjects.

Posted

Median

Full Range

Log2 titer

Day 1, Day 15, Day 29, Day 57 and Day 85/Early Termination

ID	Title	Description
OG000	Bococizumab 150 mg Abdomen	Participants received a single dose of bococizumab 150 mg SC to the abdomen.
OG001	Bococizumab 150 mg Thigh	Participants received a single dose of bococizumab 150 mg SC to the thigh.

Units	Counts
Participants	OG000

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Noninfective conjunctivitis	Eye disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected25 at risk EG0010 affected25 at risk EG0021 affected25 at risk
Abdominal lymphadenopathy	Blood and lymphatic system disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected25 at risk EG0020 affected25 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected25 at risk EG0010 affected25 at risk EG0021 affected25 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected25 at risk EG0021 affected25 at risk
Food poisoning	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 affected25 at risk EG0010 affected25 at risk EG0020 affected25 at risk
Frequent bowel movements	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected25 at risk EG0021 affected25 at risk
Nausea	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected25 at risk EG0020 affected25 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected25 at risk EG0020 affected25 at risk
Tongue dry	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected25 at risk EG0010 affected25 at risk EG0021 affected25 at risk
Toothache	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 affected25 at risk EG0010 affected25 at risk EG0021 affected25 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected25 at risk EG0020 affected25 at risk
Fatigue	General disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected25 at risk EG0020 affected25 at risk
Injection site erythema	General disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 affected25 at risk EG0010 affected25 at risk EG0022 affected25 at risk
Injection site induration	General disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 affected25 at risk EG0012 affected25 at risk EG0020 affected25 at risk
Injection site pain	General disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 affected25 at risk EG0010 affected25 at risk EG0020 affected25 at risk
Injection site pruritus	General disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected25 at risk EG0010 affected25 at risk EG0021 affected25 at risk
Injection site reaction	General disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 affected25 at risk EG0013 affected25 at risk EG0021 affected25 at risk
Injection site swelling	General disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected25 at risk EG0020 affected25 at risk
Therapeutic response changed	General disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected25 at risk EG0020 affected25 at risk
Diverticulitis	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected25 at risk EG0020 affected25 at risk
Gastroenteritis	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0000 affected25 at risk EG0010 affected25 at risk EG0021 affected25 at risk
Infected dermal cyst	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0001 affected25 at risk EG0010 affected25 at risk EG0020 affected25 at risk
Tonsillitis	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0001 affected25 at risk EG0010 affected25 at risk EG0020 affected25 at risk
Tooth abscess	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected25 at risk EG0020 affected25 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0002 affected25 at risk EG0014 affected25 at risk EG0021 affected25 at risk
Urinary tract infection	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0000 affected25 at risk EG0012 affected25 at risk EG0020 affected25 at risk
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 17.1	Non-systematic Assessment	EG0000 affected25 at risk EG0010 affected25 at risk EG0021 affected25 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected25 at risk EG0021 affected25 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected25 at risk EG0020 affected25 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected25 at risk EG0010 affected25 at risk EG0021 affected25 at risk
Dizziness	Nervous system disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 affected25 at risk EG0010 affected25 at risk EG0020 affected25 at risk
Headache	Nervous system disorders	MedDRA 17.1	Non-systematic Assessment	EG0002 affected25 at risk EG0012 affected25 at risk EG0021 affected25 at risk
Presyncope	Nervous system disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected25 at risk EG0020 affected25 at risk
Sinus headache	Nervous system disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected25 at risk EG0010 affected25 at risk EG0021 affected25 at risk
Insomnia	Psychiatric disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected25 at risk EG0010 affected25 at risk EG0021 affected25 at risk
Respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected25 at risk EG0020 affected25 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0002 affected25 at risk EG0011 affected25 at risk EG0020 affected25 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0002 affected25 at risk EG0010 affected25 at risk EG0021 affected25 at risk
Haematoma	Vascular disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 affected25 at risk EG0010 affected25 at risk EG0020 affected25 at risk

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

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Bococizumab 150 mg Abdomen	Participants received a single dose of bococizumab 150 mg SC to the abdomen.	0	25	13	25
EG001	Bococizumab 150 mg Thigh	Participants received a single dose of bococizumab 150 mg SC to the thigh.	1	25	15	25
EG002	Bococizumab 150 mg Upper Arm	Participants received a single dose of bococizumab 150 mg SC to the upper arm.	0	25	12	25