Open-label Extension (OLE) Study to Assess Safety and Eff... | NCT02304484

NCT02304484

ID	Type	Description	Link
2014-001524-30	EudraCT Number

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
Evolocumab	Experimental	Participants received 420 mg evolocumab once a month for up to 2 years.	Biological: Evolocumab

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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Adverse Events	The severity of each adverse event (AE) was graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 criteria, where Grade 1 = Mild AE, Grade 2 = Moderate AE, Grade 3 = Severe or medically significant AE, Grade 4 = Life-threatening consequences, and Grade 5 = death related to AE. An adverse device effect was defined as any adverse event related to the use of a medical device (autoinjector/pen or automated mini doser [AMD]), including but not limited to, AEs resulting from insufficient or inadequate Instructions for Use, AEs resulting from any malfunction of the device, or AEs resulting from use error or from intentional misuse of the device.	From first dose of evolocumab up to 30 days after the last dose, or end of study, whichever was earlier, up to 108 weeks.

Secondary Outcomes

Measure	Description	Time Frame
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)		Baseline (of study 20120153) and weeks 0, 4, 12, 24, 36, 48, 52, 76, and 104 of study 20140128

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
MD	Amgen	Study Director

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

Label	URL
AmgenTrials clinical trials website	View source

Results Section

Participant Flow Module

ID	Title	Description
FG000	Evolocumab	Participants received 420 mg evolocumab once a month for up to 2 years.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
SAP	No	Yes	No	Statistical Analysis Plan	Jun 9, 2017	Feb 27, 2019

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

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
	BG00059.5± 8.8

Age, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
18 - 64 years	BG000536
≥ 65 years	BG000234

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000202
Male	BG000568

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00038
Not Hispanic or Latino	BG000732

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0001
Asian	BG00019

Low-density Lipoprotein Cholesterol (LDL-C) Concentration

Baseline is defined as parent study 20120153 baseline.

Mean

Standard Deviation

mg/dL

Title

Denominators

Categories

Title	Measurements
	BG00092.2± 27.3

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

Number of Participants With Adverse Events

The severity of each adverse event (AE) was graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 criteria, where Grade 1 = Mild AE, Grade 2 = Moderate AE, Grade 3 = Severe or medically significant AE, Grade 4 = Life-threatening consequences, and Grade 5 = death related to AE.

An adverse device effect was defined as any adverse event related to the use of a medical device (autoinjector/pen or automated mini doser [AMD]), including but not limited to, AEs resulting from insufficient or inadequate Instructions for Use, AEs resulting from any malfunction of the device, or AEs resulting from use error or from intentional misuse of the device.

All enrolled participants

Posted

Count of Participants

Participants

From first dose of evolocumab up to 30 days after the last dose, or end of study, whichever was earlier, up to 108 weeks.

ID	Title	Description
OG000	Evolocumab	Participants received 420 mg evolocumab once a month for up to 2 years.

Units	Counts
Participants	OG000770

Title

Denominators

Categories

Any adverse event

Title	Measurements
	OG000526

Adverse events ≥ Grade 2

Title	Measurements
	OG000415

Adverse events ≥ Grade 3

Secondary

Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)

Enrolled participants with available data at each time point

Posted

Mean

Standard Deviation

percent change

Baseline (of study 20120153) and weeks 0, 4, 12, 24, 36, 48, 52, 76, and 104 of study 20140128

ID	Title	Description
OG000	Evolocumab	Participants received 420 mg evolocumab once a month for up to 2 years.

Units	Counts
Participants	OG000770

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Evolocumab	Participants received 420 mg evolocumab once a month for up to 2 years.	9	770	153	770	49	770

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected770 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0004 affected770 at risk
Angina pectoris	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG00013 affected770 at risk
Angina unstable	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0005 affected770 at risk
Arteriospasm coronary	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0005 affected770 at risk
Atrial flutter	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Cardiac arrest	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected770 at risk
Cardiac failure	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected770 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0003 affected770 at risk
Cardiac ventricular thrombosis	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Congestive cardiomyopathy	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Coronary artery disease	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0004 affected770 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Left ventricular failure	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Myocardial infarction	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Palpitations	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Pericarditis	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Sinus bradycardia	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected770 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected770 at risk
Cataract	Eye disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected770 at risk
Diplopia	Eye disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Abdominal adhesions	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Colitis	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Duodenal perforation	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Incarcerated umbilical hernia	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Intestinal haemorrhage	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Pancreatitis chronic	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Peptic ulcer	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Vomiting	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Chest discomfort	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Chest pain	General disorders	MedDRA 20.1	Systematic Assessment	EG0004 affected770 at risk
Fatigue	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Malaise	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Non-cardiac chest pain	General disorders	MedDRA 20.1	Systematic Assessment	EG0006 affected770 at risk
Sudden death	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Vascular stent occlusion	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Cholangitis	Hepatobiliary disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected770 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 20.1	Systematic Assessment	EG0003 affected770 at risk
Cholecystitis chronic	Hepatobiliary disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected770 at risk
Portal vein thrombosis	Hepatobiliary disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Contrast media reaction	Immune system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Appendicitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0002 affected770 at risk
Bacterial colitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Cellulitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Chronic sinusitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Dengue fever	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Diabetic foot infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Diverticulitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Gastroenteritis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Lung abscess	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Lymph gland infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Pertussis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Pneumonia	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0004 affected770 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0002 affected770 at risk
Sepsis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Staphylococcal osteomyelitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Anastomotic leak	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Epicondylitis	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0003 affected770 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Intentional overdose	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Meniscus injury	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0002 affected770 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Subarachnoid haematoma	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Anticoagulation drug level above therapeutic	Investigations	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected770 at risk
Gout	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Type 1 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected770 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected770 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected770 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0005 affected770 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Periarthritis	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Benign salivary gland neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Bladder transitional cell carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0002 affected770 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0002 affected770 at risk
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0002 affected770 at risk
Metastases to stomach	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Metastases to urinary tract	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Metastatic gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Metastatic malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Oesophageal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0002 affected770 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected770 at risk
Cervical radiculopathy	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Dizziness	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Generalised tonic-clonic seizure	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Parkinsonism	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Sciatica	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Syncope	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0003 affected770 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected770 at risk
Device loosening	Product Issues	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Suicidal ideation	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Haematuria	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Renal cyst	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected770 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected770 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0004 affected770 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Idiopathic pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Skin haemorrhage	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Hypotension	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk
Venous thrombosis	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected770 at risk

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