A Study of LY3015014 in Participants With High Cholesterol | NCT01890967

ID	Type	Description	Link
I5S-MC-EFJE	Other Identifier	Eli Lilly and Company

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
20 mg LY3015014 Q4W	Experimental	20 milligrams (mg) LY3015014 given subcutaneously (SC) once every 4 weeks (Q4W) for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.	Drug: LY3015014 Drug: Statin Drug: Ezetimibe
120 mg LY3015014 Q4W	Experimental	120 mg LY3015014 given SC Q4W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.	Drug: LY3015014 Drug: Statin Drug: Ezetimibe
300 mg LY3015014 Q4W	Experimental	300 mg LY3015014 given SC Q4W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.	Drug: LY3015014 Drug: Statin Drug: Ezetimibe
100 mg LY3015014 Q8W	Experimental	100 mg LY3015014 given SC once every 8 weeks (Q8W) for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.	Drug: LY3015014 Drug: Statin Drug: Ezetimibe
300 mg LY3015014 Q8W

Name	Type	Description	Arm Group Labels	Other Names
LY3015014	Drug	Administered SC	100 mg LY3015014 Q8W 120 mg LY3015014 Q4W 20 mg LY3015014 Q4W 300 mg LY3015014 Q4W 300 mg LY3015014 Q8W

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)	Least square (LS) Means was calculated using analysis of covariance (ANCOVA) adjusted for disease classification, statin dose, baseline LDL-C measurement. Percent change from baseline response is the dependent variable.	Baseline, Week 16

Secondary Outcomes

Measure	Description	Time Frame
Percentage Change From Baseline in LDL-C, Total Cholesterol (TC), High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), Non-HDL-C	LS Mean was calculated using mixed model repeated measures (MMRM) analysis with baseline measurement, disease classification, statin dose, treatment, visit, and treatment by visit interaction included in the model. Percent change from baseline response is the dependent variable.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosed with high low density lipoprotein (LDL) cholesterol
Are on stable daily dose of a statin or have a history of statin intolerance
Men with a partner who can become pregnant must agree to use barrier protection during sexual intercourse to prevent pregnancies
Women who cannot become pregnant, or women who are not pregnant or breast feeding and agree to use a reliable method of birth control to prevent pregnancies

Exclusion Criteria:

Have high cholesterol due to another disease or have a rare and serious form of hereditary high cholesterol
Have had recent heart attack, stroke, blood clot or heart surgery, have planned heart or blood vessel surgery, or has a heart that does not pump sufficiently well
Have poorly controlled high blood pressure
Have diabetes that requires an injectable medication (including insulin), or have diabetes that is poorly controlled
Have thyroid blood test that is outside normal range
Have a history of adrenal gland disorder
Have a history of vitamin E deficiency or fat malabsorption syndrome
Have poor kidney function
Have active liver or gall bladder disease, history of hepatitis or liver blood tests that are high
Have a history of muscle disease including muscle damage from a medicine or muscle blood test that is high
Are anemic (low red blood cell counts)
Have a history of allergy or intolerance to other antibody medications
Have a history of human immunodeficiency virus infection (HIV) infection
Are likely to have a major operation or be hospitalized during the study
Have chronic alcohol or drug abuse or dependency
Have or suspected to have any cancer or malignant tumor
Have an active serious infection
Have started or stopped taking a statin or ezetimibe medication, or changed statin dose regimen recently
Are on a statin regimen other than daily dosing (for example, an every-other-day statin regimen)
Have recently used simvastatin (highest dose level), fibrates, bile acid binders, niacin, probucol, or over-the-counter/health food preparations to lower cholesterol (such as red yeast rice, fish oil, omega 3 fatty acid)
Have undergone LDL apheresis in the past 1 year
Have recently used steroids, cyclosporine or isotretinoin
Have recently used an immunosuppressive therapy
Have recently received treatment with another antibody medication
Are currently using medications injected into the skin , except for single injections (for example flu vaccines) or injections into muscles
Are currently on a prescription or over-the-counter medicine for weight loss or are on a very low carbohydrate diet

Name	Affiliation	Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST)	Eli Lilly and Company	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.		Encino	California	91436

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo Q4W	Placebo given subcutaneously (SC) once every 4 weeks (Q4W) for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
FG001	20 mg LY3015014 Q4W

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Placebo Q4W	Placebo given SC Q4W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
BG001	20 mg LY3015014 Q4W	20 mg LY3015014 given subcutaneously SC Q4W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
BG002	120 mg LY3015014 Q4W	120 mg LY3015014 given SC Q4W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
BG003	300 mg LY3015014 Q4W	300 mg LY3015014 given SC Q4W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
BG004	100 mg LY3015014 Q8W	100 mg LY3015014 given SC Q8W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
BG005	300 mg LY3015014 Q8W	300 mg LY3015014 given SC Q8W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
BG006	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00057.9± 11.2 BG00157.2± 9.4 BG00257.1± 12.4 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00040 BG00142 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0003 BG0012 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Region of Enrollment

Number

Participants

Title

Denominators

Categories

Canada

Title	Measurements
	BG00013 BG00117 BG002

Serum LDL Cholesterol Beta Quantification

Mean

Standard Deviation

milligrams per deciliter (mg/dL)

Title

Denominators

Categories

Title	Measurements
	BG000136.5± 39.6 BG001134.1± 42.4 BG002

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

Percentage Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)

Least square (LS) Means was calculated using analysis of covariance (ANCOVA) adjusted for disease classification, statin dose, baseline LDL-C measurement. Percent change from baseline response is the dependent variable.

Modified Intent to Treat (mITT) is defined as all patients in the ITT population who had at least one baseline measurement and one post-randomization measurement of the variable that is analyzed.

Posted

Least Squares Mean

Standard Error

Percentage change

Baseline, Week 16

ID	Title	Description
OG000	Placebo Q4W	Placebo given SC Q4W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
OG001	20 mg LY3015014 Q4W	20 mg LY3015014 given SC Q4W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
OG002	120 mg LY3015014 Q4W	120 mg LY3015014 given SC Q4W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
OG003	300 mg LY3015014 Q4W	300 mg LY3015014 given SC Q4W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
OG004	100 mg LY3015014 Q8W	100 mg LY3015014 given SC Q8W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
OG005	300 mg LY3015014 Q8W	300 mg LY3015014 given SC Q8W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.

Units	Counts
Participants	OG00079 OG00175 OG00278 OG003

Title

Denominators

Categories

Title	Measurements
	OG0007.6± 2.27 OG001-14.9± 2.39 OG002-40.5± 2.31 OG003

Secondary

Percentage Change From Baseline in LDL-C, Total Cholesterol (TC), High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), Non-HDL-C

LS Mean was calculated using mixed model repeated measures (MMRM) analysis with baseline measurement, disease classification, statin dose, treatment, visit, and treatment by visit interaction included in the model. Percent change from baseline response is the dependent variable.

mITT is defined as all patients in the ITT population who had at least one baseline measurement and one post-randomization measurement of the variable that is analyzed.

Posted

Least Squares Mean

Standard Error

Percentage change

Baseline, Week 16

ID	Title	Description
OG000	Placebo Q4W	Placebo given SC Q4W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
OG001	20 mg LY3015014 Q4W	20 mg LY3015014 given SC Q4W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
OG002	120 mg LY3015014 Q4W	120 mg LY3015014 given SC Q4W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.

Secondary

Percentage Change From Baseline in Apolipoprotein A1 (Apo A1), Apolipoprotein B (Apo B)

LS Mean was calculated using MMRM analysis with baseline measurement, disease classification, statin dose, treatment, visit, and treatment by visit interaction included in the model. Percent change from baseline response is the dependent variable.

mITT is defined as all patients in the ITT population who had at least one baseline measurement and one post-randomization measurement of the variable that is analyzed.

Posted

Least Squares Mean

Standard Error

Percentage change

Baseline, Week 16

ID	Title	Description
OG000	Placebo Q4W	Placebo given SC Q4W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
OG001	20 mg LY3015014 Q4W	20 mg LY3015014 given SC Q4W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
OG002	120 mg LY3015014 Q4W	120 mg LY3015014 given SC Q4W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.

Secondary

Percentage Change From Baseline in Lipoprotein(a) [Lp(a)]

Data was log-transformed for MMRM analysis, with change from baseline as the dependent variable, and baseline measurement, disease classification, statin dose, treatment, visit, and treatment by visit interaction included as independent variables. Percentage change from baseline in the original scale was then back-calculated from the log-transformed MMRM analysis.

mITT is defined as all patients in the ITT population who had at least one baseline measurement and one post-randomization measurement of the variable that is analyzed.

Posted

Least Squares Mean

Standard Error

Percentage Change

Baseline, Week 16

ID	Title	Description
OG000	Placebo Q4W	Placebo given SC Q4W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
OG001	20 mg LY3015014 Q4W	20 mg LY3015014 given SC Q4W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
OG002	120 mg LY3015014 Q4W	120 mg LY3015014 given SC Q4W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.

Secondary

Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP)

mITT is defined as all patients in the ITT population who had at least one baseline measurement and one post-randomization measurement of the variable that is analyzed.

Posted

Least Squares Mean

Standard Error

Percentage change

Baseline, Week 16

ID	Title	Description
OG000	Placebo Q4W	Placebo given SC Q4W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
OG001	20 mg LY3015014 Q4W	20 mg LY3015014 given SC Q4W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
OG002	120 mg LY3015014 Q4W	120 mg LY3015014 given SC Q4W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.

Secondary

Number of Participants Who Develop Treatment Emergent Anti-LY3015014 Antibodies

All randomized participants who received at least one dose of study treatment and had evaluable data.

Posted

Number

Participants

Baseline through Week 24

ID	Title	Description
OG000	Placebo Q4W	Placebo given SC Q4W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
OG001	20 mg LY3015014 Q4W	20 mg LY3015014 given SC Q4W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
OG002	120 mg LY3015014 Q4W	120 mg LY3015014 given SC Q4W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
OG003	300 mg LY3015014 Q4W	300 mg LY3015014 given SC Q4W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.

Secondary

Percentage Change From Baseline in Total Proprotein Convertase Subtilisin/Kexin Type 9 Antibody (PCSK9) Levels

mITT is defined as all patients in the ITT population who had at least one baseline measurement and one post-randomization measurement of the variable that is analyzed.

Posted

Least Squares Mean

Standard Error

Percentage change

Baseline, Week 16

ID	Title	Description
OG000	Placebo Q4W	Placebo given SC Q4W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
OG001	20 mg LY3015014 Q4W	20 mg LY3015014 given SC Q4W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
OG002	120 mg LY3015014 Q4W	120 mg LY3015014 given SC Q4W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.

Secondary

Percentage Change From Baseline in Free Proprotein Convertase Subtilisin/Kexin Type 9 Antibody (PCSK9) Levels

mITT is defined as all patients in the ITT population who had at least one baseline measurement and one post-randomization measurement of the variable that is analyzed.

Posted

Least Squares Mean

Standard Error

Percentage change

Baseline, Week 16

ID	Title	Description
OG000	Placebo Q4W	Placebo given SC Q4W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
OG001	20 mg LY3015014 Q4W	20 mg LY3015014 given SC Q4W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
OG002	120 mg LY3015014 Q4W	120 mg LY3015014 given SC Q4W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.

Secondary

Pharmacokinetics (PK): Area Under the Concentration-Time Curve at Steady-State (AUC,ss) for LY3015014

All randomly assigned participants who received at least one dose of the study medication and had evaluable data.

Posted

Geometric Mean

Geometric Coefficient of Variation

μg∙hr/mL

Week 12-16 (Q4W) - Predose, Week 8-16 (Q8W) - Predose

ID	Title	Description
OG000	20 mg LY3015014 Q4W	20 mg LY3015014 given SC Q4W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
OG001	120 mg LY3015014 Q4W	120 mg LY3015014 given SC Q4W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
OG002	300 mg LY3015014 Q4W	300 mg LY3015014 given SC Q4W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
OG003	100 mg LY3015014 Q8W	100 mg LY3015014 given SC Q8W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.

Secondary

Number of Participants With an Injection Site Reaction

All randomized participants who received at least one dose of study treatment and had evaluable data.

Posted

Number

Participants

Baseline through Week 24

ID	Title	Description
OG000	Placebo Q4W	Placebo given SC Q4W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
OG001	20 mg LY3015014 Q4W	20 mg LY3015014 given SC Q4W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
OG002	120 mg LY3015014 Q4W	120 mg LY3015014 given SC Q4W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
OG003	300 mg LY3015014 Q4W	300 mg LY3015014 given SC Q4W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo Q4W	Placebo given SC Q4W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.	5	87	63	87
EG001	20 mg LY3015014 Q4W	20 mg LY3015014 given SC Q4W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.	3	87	69	87
EG002	120 mg LY3015014 Q4W	120 mg LY3015014 given SC Q4W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.	6	86	64	86
EG003	300 mg LY3015014 Q4W	300 mg LY3015014 given SC Q4W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.	2	86	64	86
EG004	100 mg LY3015014 Q8W	100 mg LY3015014 given SC Q8W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.	2	86	64	86
EG005	300 mg LY3015014 Q8W	300 mg LY3015014 given SC Q8W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.	4	87	58	87

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Atrial fibrillation	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected87 at risk EG0010 events0 affected87 at risk EG0020 events0 affected86 at risk EG0030 events0 affected86 at risk EG0040 events0 affected86 at risk EG0050 events0 affected87 at risk
Atrial flutter	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected87 at risk EG0011 events1 affected87 at risk EG0020 events0 affected86 at risk EG003
Coronary artery stenosis	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected87 at risk EG0011 events1 affected87 at risk EG0020 events0 affected86 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected87 at risk EG0010 events0 affected87 at risk EG0020 events0 affected86 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected87 at risk EG0010 events0 affected87 at risk EG0020 events0 affected86 at risk EG003
Mechanical ileus	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected87 at risk EG0010 events0 affected87 at risk EG0021 events1 affected86 at risk EG003
Chest pain	General disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected87 at risk EG0010 events0 affected87 at risk EG0020 events0 affected86 at risk EG003
Lobar pneumonia	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected87 at risk EG0010 events0 affected87 at risk EG0021 events1 affected86 at risk EG003
Pneumonia	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected87 at risk EG0010 events0 affected87 at risk EG0021 events1 affected86 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected87 at risk EG0010 events0 affected87 at risk EG0020 events0 affected86 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected87 at risk EG0010 events0 affected87 at risk EG0020 events0 affected86 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected87 at risk EG0010 events0 affected87 at risk EG0021 events1 affected86 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected87 at risk EG0010 events0 affected87 at risk EG0020 events0 affected86 at risk EG003
Laryngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected87 at risk EG0010 events0 affected87 at risk EG0020 events0 affected86 at risk EG003
Meningeal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected87 at risk EG0010 events0 affected87 at risk EG0020 events0 affected86 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected45 at risk EG0020 events0 affected45 at risk EG003
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected87 at risk EG0011 events1 affected87 at risk EG0020 events0 affected86 at risk EG003
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected87 at risk EG0010 events0 affected87 at risk EG0021 events1 affected86 at risk EG003
Loss of consciousness	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected87 at risk EG0010 events0 affected87 at risk EG0020 events0 affected86 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected87 at risk EG0010 events0 affected87 at risk EG0020 events0 affected86 at risk EG003
Subarachnoid haemorrhage	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected87 at risk EG0010 events0 affected87 at risk EG0020 events0 affected86 at risk EG003
Pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected42 at risk EG0021 events1 affected41 at risk EG003
Calculus ureteric	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected87 at risk EG0010 events0 affected87 at risk EG0020 events0 affected86 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected87 at risk EG0010 events0 affected87 at risk EG0021 events1 affected86 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0003 events2 affected87 at risk EG0019 events6 affected87 at risk EG0026 events6 affected86 at risk EG0033 events3 affected86 at risk EG0044 events3 affected86 at risk EG0051 events1 affected87 at risk
Nausea	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0004 events4 affected87 at risk EG0010 events0 affected87 at risk EG0026 events6 affected86 at risk EG003
Influenza like illness	General disorders	MedDRA 17.0	Systematic Assessment	EG0008 events6 affected87 at risk EG0012 events2 affected87 at risk EG0021 events1 affected86 at risk EG003
Injection site bruising	General disorders	MedDRA 17.0	Systematic Assessment	EG0004 events4 affected87 at risk EG0011 events1 affected87 at risk EG0029 events8 affected86 at risk EG003
Injection site erythema	General disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected87 at risk EG0011 events1 affected87 at risk EG00210 events9 affected86 at risk EG003
Injection site pain	General disorders	MedDRA 17.0	Systematic Assessment	EG0006 events3 affected87 at risk EG00120 events15 affected87 at risk EG00217 events11 affected86 at risk EG003
Injection site pruritus	General disorders	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected87 at risk EG0016 events4 affected87 at risk EG0026 events6 affected86 at risk EG003
Injection site reaction	General disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected87 at risk EG0011 events1 affected87 at risk EG0027 events5 affected86 at risk EG003
Bronchitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0006 events5 affected87 at risk EG0010 events0 affected87 at risk EG0022 events2 affected86 at risk EG003
Influenza	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0003 events3 affected87 at risk EG0015 events5 affected87 at risk EG0023 events2 affected86 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG00017 events15 affected87 at risk EG00123 events20 affected87 at risk EG00222 events22 affected86 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0004 events4 affected87 at risk EG0012 events1 affected87 at risk EG0025 events5 affected86 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0005 events5 affected87 at risk EG0013 events3 affected87 at risk EG0023 events3 affected86 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0003 events3 affected87 at risk EG0016 events4 affected87 at risk EG00210 events9 affected86 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0003 events3 affected87 at risk EG0019 events6 affected87 at risk EG0028 events6 affected86 at risk EG003
Headache	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0007 events6 affected87 at risk EG0017 events6 affected87 at risk EG00213 events11 affected86 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0005 events5 affected87 at risk EG0013 events3 affected87 at risk EG0026 events5 affected86 at risk EG003
Hypertension	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected87 at risk EG0013 events3 affected87 at risk EG0023 events3 affected86 at risk EG003

Ancestor Terms

ID	Term
D000924	Anticholesteremic Agents
D000960	Hypolipidemic Agents
D000963	Antimetabolites
D045504	Molecular Mechanisms of Pharmacological Action
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses
D004791	Enzyme Inhibitors
D057847	Lipid Regulating Agents
D045506	Therapeutic Uses
D011758	Pyrroles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D006538	Heptanoic Acids
D005227	Fatty Acids
D008055	Lipids
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D011083	Polycyclic Compounds
D013449	Sulfonamides
D000577	Amides
D005464	Fluorobenzenes
D006845	Hydrocarbons, Fluorinated
D006846	Hydrocarbons, Halogenated
D013450	Sulfones
D013457	Sulfur Compounds
D011743	Pyrimidines
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D001384	Azetidines
D001385	Azetines

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

ID	Term
C000610655	frovocimab
D019161	Hydroxymethylglutaryl-CoA Reductase Inhibitors
D000069059	Atorvastatin
D019821	Simvastatin
D000068718	Rosuvastatin Calcium
D017035	Pravastatin
D008148	Lovastatin
D000077340	Fluvastatin
C108475	pitavastatin
D000069438	Ezetimibe