GLobal Assessment of Plaque reGression With a PCSK9 antib... | NCT01813422

ID	Type	Description	Link
2012-004208-37	EudraCT Number

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Participants received placebo to evolocumab administered by subcutaneous injection once a month for 76 weeks.	Drug: Placebo
Evolocumab	Experimental	Participants received 420 mg evolocumab administered by subcutaneous injection once a month for 76 weeks.	Biological: Evolocumab

Name	Type	Description	Arm Group Labels	Other Names
Evolocumab	Biological	Administered by subcutaneous injection	Evolocumab

Measure	Description	Time Frame
Change From Baseline in Percent Atheroma Volume at Week 78	Intravascular ultrasound (IVUS) was used to visualize the extent of atherosclerotic plaques in the coronary artery lumen. The extent of atherosclerosis was expressed as percent atheroma volume (PAV) in a ≥ 40 mm segment of one targeted (imaged) coronary artery, calculated as the percentage of the total vessel volume occupied by atheroma.	Baseline and week 78

Measure	Description	Time Frame
Change From Baseline in Total Atheroma Volume at Week 78	Intravascular ultrasound (IVUS) was used to visualize the extent of atherosclerotic plaques in the coronary artery lumen. Total atheroma volume (TAV) in a ≥ 40 mm segment of the targeted coronary artery was calculated as the average plaque area over the number of images that were evaluated by IVUS multiplied by the median vessel length to compensate for differences in segment length between participants.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical indication for coronary angiography
Subjects already taking statin therapy, niacin or ezetimibe at screening must have been on a stable dose for at least 4 weeks prior to screening LDL-C. Subjects not taking lipid-regulating therapy must enter the study via a lipid stabilization period. Subjects who are intolerant to statins must meet statin intolerance entry criteria
Fasting LDL-C ≥ 80 mg/dL (2.07 mmol/L) with or without additional risk factors, or, LDL-C ≥ 60 -< 80 mg/dL (1.55-2.07 mmol/L) in the presence of one major or three minor risk factors

Subjects must meet the following criteria at the qualifying coronary catheterization procedure:

Evidence of coronary heart disease (at least one lesion in a native coronary artery that has > 20% reduction in lumen diameter) or prior percutaneous intervention (PCI)
Left main coronary artery < 50% reduction in lumen diameter by visual estimation
Target coronary artery for IVUS must be accessible to the IVUS catheter, must not have a > 50% reduction in lumen diameter within the target segment (and at least 40 mm in length); cannot have undergone prior PCI or coronary artery bypass graft (CABG) and is not a candidate for intervention over the next 18 months. It may not be a bypass graft, bypassed vessel or culprit vessel for previous myocardial infarction (MI).

Exclusion Criteria:

Coronary artery bypass graft surgery < 6 weeks prior to the qualifying IVUS
New York Heart Association (NYHA) III or IV heart failure, or last known left ventricular ejection fraction less than 30%
Uncontrolled cardiac arrhythmia that is not controlled by medications in the 3 months prior to randomization
Known hemorrhagic stroke
Uncontrolled hypertension at randomization
Fasting Triglycerides ≥ 400 mg/dL (4.5 mmol/L) at screening
Type 1 diabetes or poorly controlled type 2 diabetes (hemoglobin A1c [HbA1c] > 9%) at screening.
Moderate to severe renal dysfunction (estimated glomerular filtration rate [eGFR] < 30 ml/min/1.73m²) at screening.

Name	Affiliation	Role
MD	Amgen	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Huntsville	Alabama	35801	United States
Research Site

PubMed Identifier	Type	Citation	Retractions
27846344	Background	Nicholls SJ, Puri R, Anderson T, Ballantyne CM, Cho L, Kastelein JJ, Koenig W, Somaratne R, Kassahun H, Yang J, Wasserman SM, Scott R, Ungi I, Podolec J, Ophuis AO, Cornel JH, Borgman M, Brennan DM, Nissen SE. Effect of Evolocumab on Progression of Coronary Disease in Statin-Treated Patients: The GLAGOV Randomized Clinical Trial. JAMA. 2016 Dec 13;316(22):2373-2384. doi: 10.1001/jama.2016.16951.
30336824

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 administered by subcutaneous injection once a month for 76 weeks.
FG001	Evolocumab	Participants received 420 mg evolocumab administered by subcutaneous injection once a month for 76 weeks.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

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

Change From Baseline in Percent Atheroma Volume at Week 78

Intravascular ultrasound (IVUS) was used to visualize the extent of atherosclerotic plaques in the coronary artery lumen. The extent of atherosclerosis was expressed as percent atheroma volume (PAV) in a ≥ 40 mm segment of one targeted (imaged) coronary artery, calculated as the percentage of the total vessel volume occupied by atheroma.

Randomized participants who received at least 1 dose of study drug, with a baseline IVUS and an IVUS measurement conducted after week 52 (IVUS analysis set)

Posted

Least Squares Mean

Standard Error

percent atheroma volume

Baseline and week 78

ID	Title	Description
OG000	Placebo	Participants received placebo to evolocumab administered by subcutaneous injection once a month for 76 weeks.
OG001	Evolocumab	Participants received 420 mg evolocumab administered by subcutaneous injection once a month for 76 weeks.

Units	Counts
Participants	OG000423 OG001423

Title

Denominators

Categories

Title	Measurements
	OG0000.053± 0.189 OG001-0.955± 0.190

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		ANCOVA	ANCOVA model included terms for the treatment group, the geographic region stratification factor, and baseline PAV.	< 0.0001		LS Mean Treatment Difference	-1.007	Standard Error of the Mean	0.187	2-Sided	95	-1.375	-0.640			Treatment difference uses placebo as the reference.		Superiority or Other

Secondary

Change From Baseline in Total Atheroma Volume at Week 78

Intravascular ultrasound (IVUS) was used to visualize the extent of atherosclerotic plaques in the coronary artery lumen. Total atheroma volume (TAV) in a ≥ 40 mm segment of the targeted coronary artery was calculated as the average plaque area over the number of images that were evaluated by IVUS multiplied by the median vessel length to compensate for differences in segment length between participants.

Randomized participants who received at least 1 dose of study drug, with a baseline IVUS and an IVUS measurement conducted after week 52 (IVUS analysis set)

Posted

Least Squares Mean

Standard Error

mm³

Baseline and week 78

ID	Title	Description
OG000	Placebo	Participants received placebo to evolocumab administered by subcutaneous injection once a month for 76 weeks.
OG001	Evolocumab	Participants received 420 mg evolocumab administered by subcutaneous injection once a month for 76 weeks.

Units	Counts
Participants

Secondary

Percentage of Participants With Regression in Percent Atheroma Volume

Regression in PAV was defined as any reduction from baseline in PAV.

Randomized participants who received at least 1 dose of study drug, with a baseline IVUS and an IVUS measurement conducted after week 52 (IVUS analysis set)

Posted

Number

95% Confidence Interval

percentage of participants

Baseline and week 78

ID	Title	Description
OG000	Placebo	Participants received placebo to evolocumab administered by subcutaneous injection once a month for 76 weeks.
OG001	Evolocumab	Participants received 420 mg evolocumab administered by subcutaneous injection once a month for 76 weeks.

Units	Counts
Participants

Secondary

Percentage of Participants With Regression in Total Atheroma Volume

Regression in TAV was defined as any reduction from baseline in TAV.

Randomized participants who received at least 1 dose of study drug, with a baseline IVUS and an IVUS measurement conducted after week 52 (IVUS analysis set)

Posted

Number

95% Confidence Interval

percentage of participants

Baseline and week 78

ID	Title	Description
OG000	Placebo	Participants received placebo to evolocumab administered by subcutaneous injection once a month for 76 weeks.
OG001	Evolocumab	Participants received 420 mg evolocumab administered by subcutaneous injection once a month for 76 weeks.

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0012 affected484 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0003 affected484 at risk EG0011 affected484 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0005 affected484 at risk EG0016 affected484 at risk
Angina pectoris	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG00011 affected484 at risk EG00117 affected484 at risk
Angina unstable	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0007 affected484 at risk EG0018 affected484 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0011 affected484 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0005 affected484 at risk EG0010 affected484 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0004 affected484 at risk EG0016 affected484 at risk
Atrial flutter	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Atrioventricular block	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0010 affected484 at risk
Atrioventricular block second degree	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Bradycardia	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Cardiac disorder	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Cardiac failure	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected484 at risk EG0010 affected484 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0010 affected484 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Cardiac tamponade	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Coronary artery disease	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG00013 affected484 at risk EG0017 affected484 at risk
Coronary artery dissection	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected484 at risk EG0011 affected484 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0013 affected484 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0005 affected484 at risk EG0013 affected484 at risk
Left ventricular dysfunction	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0010 affected484 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected484 at risk EG0010 affected484 at risk
Myocardial infarction	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0004 affected484 at risk EG0010 affected484 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0003 affected484 at risk EG0011 affected484 at risk
Palpitations	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected484 at risk EG0010 affected484 at risk
Pericarditis	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Sinoatrial block	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected484 at risk EG0010 affected484 at risk
Ventricular arrhythmia	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0010 affected484 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected484 at risk EG0010 affected484 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0010 affected484 at risk
Amaurosis fugax	Eye disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0010 affected484 at risk
Cataract	Eye disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Diabetic retinopathy	Eye disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0010 affected484 at risk
Retinopathy	Eye disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0010 affected484 at risk
Diverticular perforation	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0010 affected484 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0010 affected484 at risk
Erosive duodenitis	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Gastritis	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0012 affected484 at risk
Ileal perforation	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0010 affected484 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected484 at risk EG0010 affected484 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Nausea	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0010 affected484 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Vomiting	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0011 affected484 at risk
Chest discomfort	General disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0011 affected484 at risk
Chest pain	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Malaise	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Non-cardiac chest pain	General disorders	MedDRA 19.0	Systematic Assessment	EG0006 affected484 at risk EG00111 affected484 at risk
Oedema peripheral	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Puncture site haemorrhage	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Sudden death	General disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0011 affected484 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Vascular stent restenosis	General disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected484 at risk EG0013 affected484 at risk
Vascular stent stenosis	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Vessel puncture site haemorrhage	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected484 at risk EG0010 affected484 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0010 affected484 at risk
Gallbladder enlargement	Hepatobiliary disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0010 affected484 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Abdominal abscess	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0010 affected484 at risk
Appendicitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0011 affected484 at risk
Brain abscess	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Bronchitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0012 affected484 at risk
Bursitis infective staphylococcal	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0010 affected484 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Diverticulitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0011 affected484 at risk
Eye infection toxoplasmal	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0010 affected484 at risk
Gastroenteritis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0011 affected484 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0010 affected484 at risk
Kidney infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Pneumonia	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0005 affected484 at risk EG0010 affected484 at risk
Postoperative wound infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0010 affected484 at risk
Pyelonephritis acute	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0010 affected484 at risk
Pyonephrosis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Sepsis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Sinusitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0010 affected484 at risk
Urinary tract infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0012 affected484 at risk
Vestibular neuronitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0011 affected484 at risk
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0010 affected484 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0012 affected484 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0012 affected484 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0010 affected484 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Limb traumatic amputation	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0010 affected484 at risk
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0011 affected484 at risk
Procedural dizziness	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0010 affected484 at risk
Skeletal injury	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0011 affected484 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Alanine aminotransferase increased	Investigations	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0012 affected484 at risk
Arteriogram coronary	Investigations	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Blood creatinine increased	Investigations	MedDRA 19.0	Systematic Assessment	EG0002 affected484 at risk EG0010 affected484 at risk
Blood pressure increased	Investigations	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Liver function test increased	Investigations	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0010 affected484 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected484 at risk EG0012 affected484 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Obesity	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0010 affected484 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0003 affected484 at risk EG0010 affected484 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0010 affected484 at risk
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0011 affected484 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0012 affected484 at risk
Joint effusion	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0010 affected484 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0010 affected484 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0012 affected484 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0004 affected484 at risk EG0011 affected484 at risk
Osteochondrosis	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0010 affected484 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0011 affected484 at risk
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0010 affected484 at risk
Spondylitis	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0010 affected484 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Vertebral foraminal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0010 affected484 at risk
Acoustic neuroma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Basosquamous carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0010 affected484 at risk
Benign pancreatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0010 affected484 at risk
Bladder cancer stage I, with cancer in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0010 affected484 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0002 affected484 at risk EG0010 affected484 at risk
Cervix carcinoma stage 0	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Chemodectoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0010 affected484 at risk
Endometrial adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Gastrointestinal tract adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0010 affected484 at risk
Hepatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0011 affected484 at risk
Lung adenocarcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0010 affected484 at risk
Lung carcinoma cell type unspecified stage III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0010 affected484 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0002 affected484 at risk EG0010 affected484 at risk
Rectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0010 affected484 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Skin cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0010 affected484 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Ureteral neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0010 affected484 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0010 affected484 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected484 at risk EG0010 affected484 at risk
Epilepsy	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Facial paresis	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Intracranial aneurysm	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0010 affected484 at risk
Loss of consciousness	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Sciatica	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Sensory disturbance	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Syncope	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0013 affected484 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0011 affected484 at risk
Tremor	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Device leakage	Product Issues	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0010 affected484 at risk
Anxiety disorder	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Depression	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0013 affected484 at risk
Mental status changes	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0010 affected484 at risk
Paranoia	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0010 affected484 at risk
Bladder prolapse	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0010 affected484 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0013 affected484 at risk
Renal artery stenosis	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0010 affected484 at risk
Renal colic	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Stress urinary incontinence	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0010 affected484 at risk
Ureteric obstruction	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Urinary retention	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected484 at risk EG0010 affected484 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0012 affected484 at risk
Cervical polyp	Reproductive system and breast disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Uterine haemorrhage	Reproductive system and breast disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0010 affected484 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0011 affected484 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0014 affected484 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0010 affected484 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0010 affected484 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0010 affected484 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0010 affected484 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0012 affected484 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Coronary arterial stent insertion	Surgical and medical procedures	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0010 affected484 at risk
Coronary revascularisation	Surgical and medical procedures	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0011 affected484 at risk
Hip arthroplasty	Surgical and medical procedures	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Mammoplasty	Surgical and medical procedures	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Aortic aneurysm	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0012 affected484 at risk
Arteriosclerosis	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected484 at risk EG0010 affected484 at risk
Hypertension	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0004 affected484 at risk EG0010 affected484 at risk
Hypotension	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0013 affected484 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected484 at risk EG0011 affected484 at risk
Peripheral artery thrombosis	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Raynaud's phenomenon	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected484 at risk EG0010 affected484 at risk
Vasoconstriction	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk
Vessel perforation	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected484 at risk EG0011 affected484 at risk

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

ID	Title	Description
BG000	Placebo	Participants received placebo to evolocumab administered by subcutaneous injection once a month for 76 weeks.
BG001	Evolocumab	Participants received 420 mg evolocumab administered by subcutaneous injection once a month for 76 weeks.
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	Participants received placebo to evolocumab administered by subcutaneous injection once a month for 76 weeks.			142	484	120	484
EG001	Evolocumab	Participants received 420 mg evolocumab administered by subcutaneous injection once a month for 76 weeks.			135	484	114	484