Effects of Proprotein Convertase Subtilisin/Kexin Type 9... | NCT02729025

ID	Type	Description	Link
2015-003731-35	EudraCT Number

Status Module

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Participants received placebo to evolocumab by subcutaneous injection once a month (QM) for 12 weeks.	Drug: Placebo
Evolocumab 420 mg QM	Experimental	Participants received 420 mg evolocumab by subcutaneous injection once a month (QM) for 12 weeks.	Drug: Evolocumab

Name	Type	Description	Arm Group Labels	Other Names
Evolocumab	Drug	Administered subcutaneously once a month using an autoinjector/pen.	Evolocumab 420 mg QM

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent Change From Baseline in Maximum Target-to-background Ratio in the Most Diseased Segment of the Index Vessel at Week 16	Arterial inflammation was assessed using 18F-fluoro-deoxyglucose positron-emission tomography/computed tomography (18F-FDG PET/CT). Arterial 18F-FDG uptake is correlated with arterial macrophage content and predicts cardiovascular events. Images were analyzed by an experienced radiologist blinded to all patient characteristics. The maximum standardized uptake value was calculated as a time- and dose- corrected tissue radioactivity divided by body weight in the index and the target-to-background ratio (TBR) was calculated from the ratio of the standardized uptake value of the artery compared to mean background venous activity. The average maximum TBR for the most diseased segment (MDS) was calculated from a group of 3 contiguous slices (approximately 1.5 cm), centered on the slice with the highest maximum TBR in the index vessel. The index vessel was defined as the vessel (either the right or left carotid or aorta) with the highest mean TBR at baseline.	Baseline and week 16

Secondary Outcomes

Measure	Description	Time Frame
Percent Change From Baseline in Lipoprotein(a) Concentration at Week 16		Baseline and week 16
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Concentration at Week 16		Baseline and week 16

Eligibility Module

Name	Affiliation	Role
MD	Amgen	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Miami	Florida	33144	United States
Research Site

PubMed Identifier	Type	Citation	Retractions
30561610	Background	Stiekema LCA, Stroes ESG, Verweij SL, Kassahun H, Chen L, Wasserman SM, Sabatine MS, Mani V, Fayad ZA. Persistent arterial wall inflammation in patients with elevated lipoprotein(a) despite strong low-density lipoprotein cholesterol reduction by proprotein convertase subtilisin/kexin type 9 antibody treatment. Eur Heart J. 2019 Sep 1;40(33):2775-2781. doi: 10.1093/eurheartj/ehy862.
33078867

Label	URL
AmgenTrials clinical trials website	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo	Participants received placebo to evolocumab by subcutaneous injection once a month (QM) for 12 weeks.
FG001	Evolocumab 420 mg QM	Participants received 420 mg evolocumab by subcutaneous injection once a month (QM) for 12 weeks.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Feb 8, 2017	Mar 29, 2019

ID	Title	Description
BG000	Placebo	Participants received placebo to evolocumab by subcutaneous injection once a month (QM) for 12 weeks.
BG001	Evolocumab 420 mg QM	Participants received 420 mg evolocumab by subcutaneous injection once a month (QM) for 12 weeks.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00064 BG00165 BG002129

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
	OG000-5.31± 1.67 OG001-8.31± 1.67

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	A multivariate regression was modelled on the primary endpoint as well as three other response variables (percent change in Lp[a] at Weeks 8 and 16, baseline MDS TBR, and baseline Lp[a]). The primary endpoint was regressed on the treatment group and statin stratification factor; baseline MDS TBR and Lp(a) were regressed on the statin stratification factor, and percent changes in Lp(a) were regressed on the treatment group, statin stratification factor, visit, and treatment group by visit.	Multivariate regression model		0.18		LS Mean Treatment Difference	-3.00	Standard Error of the Mean	2.24	2-Sided	95	-7.40	1.39			Treatment difference used placebo as the reference

Secondary

Percent Change From Baseline in Lipoprotein(a) Concentration at Week 16

Participants who received at least 1 dose of study drug with available data

Posted

Least Squares Mean

Standard Error

percent change

Baseline and week 16

ID	Title	Description
OG000	Placebo	Participants received placebo to evolocumab by subcutaneous injection once a month (QM) for 12 weeks.
OG001	Evolocumab 420 mg QM	Participants received 420 mg evolocumab by subcutaneous injection once a month (QM) for 12 weeks.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Concentration at Week 16

Participants who received at least 1 dose of study drug with available data

Posted

Least Squares Mean

Standard Error

percent change

Baseline and week 16

ID	Title	Description
OG000	Placebo	Participants received placebo to evolocumab by subcutaneous injection once a month (QM) for 12 weeks.
OG001	Evolocumab 420 mg QM	Participants received 420 mg evolocumab by subcutaneous injection once a month (QM) for 12 weeks.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Apolipoprotein B Concentration at Week 16

Participants who received at least 1 dose of study drug with available data

Posted

Least Squares Mean

Standard Error

percent change

Baseline and week 16

ID	Title	Description
OG000	Placebo	Participants received placebo to evolocumab by subcutaneous injection once a month (QM) for 12 weeks.
OG001	Evolocumab 420 mg QM	Participants received 420 mg evolocumab by subcutaneous injection once a month (QM) for 12 weeks.

Units	Counts
Participants	OG000

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Palpitations	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected64 at risk EG0011 affected65 at risk
Dermoid cyst	Congenital, familial and genetic disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected64 at risk EG0010 affected65 at risk
Muscular dystrophy	Congenital, familial and genetic disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected64 at risk EG0010 affected65 at risk
Excessive cerumen production	Ear and labyrinth disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected64 at risk EG0010 affected65 at risk
Keratitis	Eye disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected64 at risk EG0011 affected65 at risk
Lacrimation increased	Eye disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected64 at risk EG0010 affected65 at risk
Visual impairment	Eye disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected64 at risk EG0011 affected65 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected64 at risk EG0010 affected65 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected64 at risk EG0011 affected65 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected64 at risk EG0011 affected65 at risk
Dental caries	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected64 at risk EG0011 affected65 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0005 affected64 at risk EG0011 affected65 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected64 at risk EG0010 affected65 at risk
Food poisoning	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected64 at risk EG0012 affected65 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected64 at risk EG0012 affected65 at risk
Nausea	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0005 affected64 at risk EG0011 affected65 at risk
Oesophageal pain	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected64 at risk EG0010 affected65 at risk
Peptic ulcer	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected64 at risk EG0010 affected65 at risk
Toothache	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected64 at risk EG0011 affected65 at risk
Chest pain	General disorders	MedDRA 20.1	Systematic Assessment	EG0003 affected64 at risk EG0010 affected65 at risk
Chills	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected64 at risk EG0011 affected65 at risk
Drug intolerance	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected64 at risk EG0010 affected65 at risk
Fatigue	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected64 at risk EG0012 affected65 at risk
Influenza like illness	General disorders	MedDRA 20.1	Systematic Assessment	EG0004 affected64 at risk EG0014 affected65 at risk
Injection site hypersensitivity	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected64 at risk EG0010 affected65 at risk
Injection site pain	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected64 at risk EG0011 affected65 at risk
Injection site rash	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected64 at risk EG0010 affected65 at risk
Nodule	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected64 at risk EG0011 affected65 at risk
Non-cardiac chest pain	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected64 at risk EG0012 affected65 at risk
Oedema peripheral	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected64 at risk EG0010 affected65 at risk
Pain	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected64 at risk EG0011 affected65 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected64 at risk EG0011 affected65 at risk
Hypersensitivity	Immune system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected64 at risk EG0011 affected65 at risk
Seasonal allergy	Immune system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected64 at risk EG0011 affected65 at risk
Bronchitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0002 affected64 at risk EG0010 affected65 at risk
Cellulitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected64 at risk EG0011 affected65 at risk
Erysipelas	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected64 at risk EG0010 affected65 at risk
Eye infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected64 at risk EG0010 affected65 at risk
Folliculitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected64 at risk EG0011 affected65 at risk
H1N1 influenza	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected64 at risk EG0011 affected65 at risk
Herpes zoster	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected64 at risk EG0011 affected65 at risk
Heterophyiasis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected64 at risk EG0011 affected65 at risk
Influenza	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0003 affected64 at risk EG0017 affected65 at risk
Nail infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected64 at risk EG0011 affected65 at risk
Nasopharyngitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG00013 affected64 at risk EG0016 affected65 at risk
Otitis externa	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected64 at risk EG0011 affected65 at risk
Root canal infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected64 at risk EG0010 affected65 at risk
Sinusitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected64 at risk EG0011 affected65 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0002 affected64 at risk EG0012 affected65 at risk
Urinary tract infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0003 affected64 at risk EG0011 affected65 at risk
Vulvovaginal mycotic infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected64 at risk EG0010 affected65 at risk
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected64 at risk EG0011 affected65 at risk
Bone contusion	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected64 at risk EG0011 affected65 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected64 at risk EG0011 affected65 at risk
Epicondylitis	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 affected64 at risk EG0010 affected65 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected64 at risk EG0011 affected65 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 affected64 at risk EG0011 affected65 at risk
Post-traumatic pain	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 affected64 at risk EG0010 affected65 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 affected64 at risk EG0011 affected65 at risk
Vaccination complication	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 affected64 at risk EG0010 affected65 at risk
Weight decreased	Investigations	MedDRA 20.1	Systematic Assessment	EG0001 affected64 at risk EG0011 affected65 at risk
Weight increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0001 affected64 at risk EG0010 affected65 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected64 at risk EG0011 affected65 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected64 at risk EG0010 affected65 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0003 affected64 at risk EG0011 affected65 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected64 at risk EG0011 affected65 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected64 at risk EG0010 affected65 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected64 at risk EG0011 affected65 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected64 at risk EG0013 affected65 at risk
Muscle twitching	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected64 at risk EG0011 affected65 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected64 at risk EG0013 affected65 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected64 at risk EG0010 affected65 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected64 at risk EG0015 affected65 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected64 at risk EG0010 affected65 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected64 at risk EG0012 affected65 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected64 at risk EG0011 affected65 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected64 at risk EG0011 affected65 at risk
Dysplastic naevus	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0001 affected64 at risk EG0010 affected65 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected64 at risk EG0011 affected65 at risk
Cervical radiculopathy	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected64 at risk EG0011 affected65 at risk
Dizziness	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected64 at risk EG0013 affected65 at risk
Headache	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0007 affected64 at risk EG0014 affected65 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected64 at risk EG0011 affected65 at risk
Lethargy	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected64 at risk EG0011 affected65 at risk
Memory impairment	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected64 at risk EG0010 affected65 at risk
Migraine	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected64 at risk EG0011 affected65 at risk
Paraesthesia	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected64 at risk EG0011 affected65 at risk
Retinal migraine	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected64 at risk EG0010 affected65 at risk
Speech disorder	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected64 at risk EG0011 affected65 at risk
Insomnia	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected64 at risk EG0014 affected65 at risk
Irritability	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected64 at risk EG0011 affected65 at risk
Menopausal symptoms	Reproductive system and breast disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected64 at risk EG0011 affected65 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected64 at risk EG0011 affected65 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected64 at risk EG0010 affected65 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected64 at risk EG0010 affected65 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected64 at risk EG0012 affected65 at risk
Pharyngeal inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected64 at risk EG0010 affected65 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected64 at risk EG0011 affected65 at risk
Upper-airway cough syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected64 at risk EG0011 affected65 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected64 at risk EG0011 affected65 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected64 at risk EG0011 affected65 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected64 at risk EG0010 affected65 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected64 at risk EG0011 affected65 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected64 at risk EG0010 affected65 at risk
Hyperkeratosis	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected64 at risk EG0011 affected65 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected64 at risk EG0011 affected65 at risk
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected64 at risk EG0010 affected65 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected64 at risk EG0011 affected65 at risk
Rosacea	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected64 at risk EG0011 affected65 at risk
Bunion operation	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0001 affected64 at risk EG0010 affected65 at risk
Flushing	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected64 at risk EG0010 affected65 at risk
Hot flush	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected64 at risk EG0011 affected65 at risk
Hypertension	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected64 at risk EG0013 affected65 at risk
Peripheral coldness	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected64 at risk EG0011 affected65 at risk

ID	Term
D050171	Dyslipidemias
D006949	Hyperlipidemias
C566337	Hypercholesterolemia, Autosomal Dominant, 3
D007266	Inhibition, Psychological

ID	Term
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D001519	Behavior

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo QM	Participants received placebo to evolocumab by subcutaneous injection once a month (QM) for 12 weeks.	0	64	0	64	47	64
EG001	Evolocumab 420 mg QM	Participants received 420 mg evolocumab by subcutaneous injection once a month (QM) for 12 weeks.	0	65	2	65	49	65

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Diffuse large B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment		EG0000 affected64 at risk EG0011 affected65 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment		EG0000 affected64 at risk EG0011 affected65 at risk