Open Label Study of Long Term Evaluation Against LDL-C Trial | NCT01439880

ID	Type	Description	Link
2011-001915-29	EudraCT Number

Label	Type	Description	Intervention Names
Standard of Care	Active Comparator	Participants received standard of care (SOC) treatment for the first year of the study (SOC-controlled period). At week 52 participants began treatment with evolocumab 420 mg once a month (QM) for 4 years during the all-investigational product [all-IP] period.	Biological: Evolocumab Other: Standard of care
Evolocumab + SOC	Experimental	Participants received evolocumab 420 mg once a month plus standard of care for the first year of the study (SOC-controlled period). At week 52 participants continued treatment with evolocumab 420 mg QM for another 4 years during the all-IP period.	Biological: Evolocumab

Name	Type	Description	Arm Group Labels	Other Names
Evolocumab	Biological	Administered by subcutaneous injection	Evolocumab + SOC Standard of Care

Measure	Description	Time Frame
Number of Participants With Adverse Events	Adverse event (AE) severity assessments were made using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) grading, version 4.03, where grade 1 = mild AE, grade 2 = moderate AE, Grade 3 = severe AE, grade 4 = life-threatening AE and Grade 5 = death due to AE.	52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; actual median duration of treatment in the All-IP period was 46.9 months.

Measure	Description	Time Frame
Low-density Lipoprotein Cholesterol (LDL-C) Level at Week 24 and Week 52		Baseline of parent study and extension study weeks 24 and 52
Non-high-density Lipoprotein Cholesterol (Non-HDL-C) Level at Week 24 and Week 52		Baseline of parent study and extension study weeks 24 and 52

Name	Affiliation	Role
MD	Amgen	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Birmingham	Alabama	35216	United States
Research Site

PubMed Identifier	Type	Citation	Retractions
28291870	Background	Koren MJ, Sabatine MS, Giugliano RP, Langslet G, Wiviott SD, Kassahun H, Ruzza A, Ma Y, Somaratne R, Raal FJ. Long-term Low-Density Lipoprotein Cholesterol-Lowering Efficacy, Persistence, and Safety of Evolocumab in Treatment of Hypercholesterolemia: Results Up to 4 Years From the Open-Label OSLER-1 Extension Study. JAMA Cardiol. 2017 Jun 1;2(6):598-607. doi: 10.1001/jamacardio.2017.0747.
24255061

Label	URL
AmgenTrials clinical trials website	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Standard of Care	Participants randomized to receive standard of care (SOC) treatment for the first year of the extension study (SOC-controlled period). At week 52 participants began treatment with evolocumab 420 mg QM for up to 4 years in the all-investigational product [all-IP] period.
FG001

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	Nov 12, 2015	Jun 17, 2019

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

Adverse event (AE) severity assessments were made using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) grading, version 4.03, where grade 1 = mild AE, grade 2 = moderate AE, Grade 3 = severe AE, grade 4 = life-threatening AE and Grade 5 = death due to AE.

All randomized participants (year 1) and randomized participants on study and who received at least 1 dose of evolocumab in the all-IP period (years 2-5).

Posted

Count of Participants

Participants

52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; actual median duration of treatment in the All-IP period was 46.9 months.

ID	Title	Description
OG000	SOC-controlled Period: Standard of Care	Participants randomized to receive standard of care (SOC) treatment for the first year of the extension study (SOC-controlled period).
OG001	SOC-controlled Period: Evolocumab + SOC	Participants randomized to receive evolocumab 420 mg once a month plus standard of care for the first year of the extension study (SOC-controlled period).
OG002	All-IP Period: SOC / Evolocumab + SOC	At week 52 participants began treatment with evolocumab 420 mg QM for up to 4 years during the all-IP period.
OG003	All-IP Period: Evolocumab + SOC / Evolocumab + SOC	At week 52 participants continued treatment with evolocumab 420 mg QM for another 4 years during the all-IP period.

Units	Counts
Participants	OG000442 OG001882 OG002374 OG003

Title

Denominators

Categories

All adverse events

Title	Measurements
	OG000327 OG001728 OG002342 OG003

Secondary

Low-density Lipoprotein Cholesterol (LDL-C) Level at Week 24 and Week 52

Participants randomized in study 20110110 and with available data at each time point.

Posted

Mean

Standard Deviation

mg/dL

Baseline of parent study and extension study weeks 24 and 52

ID	Title	Description
OG000	Standard of Care	Participants randomized to receive standard of care (SOC) treatment for the first year of the extension study (SOC-controlled period).
OG001	Evolocumab + SOC	Participants randomized to receive evolocumab 420 mg once a month plus standard of care for the first year of the extension study (SOC-controlled period).
OG002	Control in Parent Study: SOC	Participants who received a control treatment in the parent study received standard of care treatment for the first year of the extension study.
OG003	Control in Parent Study: Evolocumab + SOC	Participants who received a control treatment in the parent study received subcutaneous evolocumab 420 mg QM plus standard of care during the first year of the extension study.

Secondary

Non-high-density Lipoprotein Cholesterol (Non-HDL-C) Level at Week 24 and Week 52

Participants randomized in the extension study 20110110 and with available data at each time point.

Posted

Mean

Standard Deviation

mg/dL

Baseline of parent study and extension study weeks 24 and 52

ID	Title	Description
OG000	Standard of Care	Participants randomized to receive standard of care (SOC) treatment for the first year of the extension study (SOC-controlled period).
OG001	Evolocumab + SOC	Participants randomized to receive evolocumab 420 mg once a month plus standard of care for the first year of the extension study (SOC-controlled period).
OG002	Control in Parent Study: SOC	Participants who received a control treatment in the parent study received standard of care treatment for the first year of the extension study.
OG003	Control in Parent Study: Evolocumab + SOC	Participants who received a control treatment in the parent study received subcutaneous evolocumab 420 mg QM plus standard of care during the first year of the extension study.

Secondary

Apolipoprotein B Level at Week 24 and Week 52

Participants randomized in the extension study 20110110 and with available data at each time point.

Posted

Mean

Standard Deviation

mg/dL

Baseline of parent study and extension study weeks 24 and 52

ID	Title	Description
OG000	Standard of Care	Participants randomized to receive standard of care (SOC) treatment for the first year of the extension study (SOC-controlled period).
OG001	Evolocumab + SOC	Participants randomized to receive evolocumab 420 mg once a month plus standard of care for the first year of the extension study (SOC-controlled period).
OG002	Control in Parent Study: SOC	Participants who received a control treatment in the parent study received standard of care treatment for the first year of the extension study.
OG003	Control in Parent Study: Evolocumab + SOC	Participants who received a control treatment in the parent study received subcutaneous evolocumab 420 mg QM plus standard of care during the first year of the extension study.

Secondary

Total Cholesterol/HDL-C Ratio at Week 24 and Week 52

Participants randomized in the extension study 20110110 and with available data at each time point.

Posted

Mean

Standard Deviation

ratio

Baseline of parent study and extension study weeks 24 and 52

ID	Title	Description
OG000	Standard of Care	Participants randomized to receive standard of care (SOC) treatment for the first year of the extension study (SOC-controlled period).
OG001	Evolocumab + SOC	Participants randomized to receive evolocumab 420 mg once a month plus standard of care for the first year of the extension study (SOC-controlled period).
OG002	Control in Parent Study: SOC	Participants who received a control treatment in the parent study received standard of care treatment for the first year of the extension study.
OG003	Control in Parent Study: Evolocumab + SOC	Participants who received a control treatment in the parent study received subcutaneous evolocumab 420 mg QM plus standard of care during the first year of the extension study.

Secondary

Apolipoprotein B/Apolipoprotein A1 Ratio at Week 24 and Week 52

Participants randomized in the extension study 20110110 and with available data at each time point.

Posted

Mean

Standard Deviation

ratio

Baseline of parent study and extension study weeks 24 and 52

ID	Title	Description
OG000	Standard of Care	Participants randomized to receive standard of care (SOC) treatment for the first year of the extension study (SOC-controlled period).
OG001	Evolocumab + SOC	Participants randomized to receive evolocumab 420 mg once a month plus standard of care for the first year of the extension study (SOC-controlled period).
OG002	Control in Parent Study: SOC	Participants who received a control treatment in the parent study received standard of care treatment for the first year of the extension study.
OG003	Control in Parent Study: Evolocumab + SOC	Participants who received a control treatment in the parent study received subcutaneous evolocumab 420 mg QM plus standard of care during the first year of the extension study.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG0031 affected822 at risk EG0041 affected1,220 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Acute coronary syndrome	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected442 at risk EG0014 affected882 at risk EG0021 affected398 at risk EG003
Angina unstable	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0011 affected882 at risk EG0021 affected398 at risk EG003
Aortic valve disease	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Aortic valve disease mixed	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Aortic valve incompetence	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Aortic valve sclerosis	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Aortic valve stenosis	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected442 at risk EG0011 affected882 at risk EG0022 affected398 at risk EG003
Atrial flutter	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Atrial thrombosis	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Bradycardia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0021 affected398 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0021 affected398 at risk EG003
Cardiogenic shock	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Cardiopulmonary failure	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0021 affected398 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0011 affected882 at risk EG0022 affected398 at risk EG003
Coronary artery embolism	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0021 affected398 at risk EG003
Coronary artery occlusion	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0011 affected882 at risk EG0020 affected398 at risk EG003
Coronary artery stenosis	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0011 affected882 at risk EG0021 affected398 at risk EG003
Mitral valve disease	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Mitral valve disease mixed	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Mitral valve incompetence	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Myocardial ischaemia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Nodal rhythm	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0011 affected882 at risk EG0020 affected398 at risk EG003
Pericarditis	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Supraventricular tachycardia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Ventricular extrasystoles	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Ventricular tachycardia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Sudden hearing loss	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0011 affected882 at risk EG0020 affected398 at risk EG003
Vertigo positional	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0011 affected882 at risk EG0020 affected398 at risk EG003
Thyroid mass	Endocrine disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Thyroiditis acute	Endocrine disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Cataract	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0022 affected398 at risk EG003
Cataract cortical	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0011 affected882 at risk EG0020 affected398 at risk EG003
Corneal defect	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Eyelid ptosis	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Keratitis	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0011 affected882 at risk EG0020 affected398 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Anal fistula	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Brunner's gland hyperplasia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0011 affected882 at risk EG0020 affected398 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Faecaloma	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0011 affected882 at risk EG0020 affected398 at risk EG003
Faeces discoloured	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0011 affected882 at risk EG0020 affected398 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0011 affected882 at risk EG0020 affected398 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0011 affected882 at risk EG0020 affected398 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Hiatus hernia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Ileus paralytic	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Impaired gastric emptying	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0011 affected882 at risk EG0021 affected398 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected442 at risk EG0010 affected882 at risk EG0022 affected398 at risk EG003
Intestinal ischaemia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0011 affected882 at risk EG0020 affected398 at risk EG003
Large intestine polyp	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0021 affected398 at risk EG003
Lumbar hernia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0021 affected398 at risk EG003
Obstructive pancreatitis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Oesophageal spasm	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0011 affected882 at risk EG0020 affected398 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0011 affected882 at risk EG0020 affected398 at risk EG003
Retroperitoneal haematoma	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Splenic artery aneurysm	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Tooth impacted	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Chest discomfort	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0011 affected882 at risk EG0020 affected398 at risk EG003
Chest pain	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected442 at risk EG0014 affected882 at risk EG0021 affected398 at risk EG003
Fatigue	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Hypothermia	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0021 affected398 at risk EG003
Mass	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Nodule	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0021 affected398 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected442 at risk EG0014 affected882 at risk EG0020 affected398 at risk EG003
Organ failure	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Pain	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Autoimmune hepatitis	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Biliary dyskinesia	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0021 affected398 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0022 affected398 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0021 affected398 at risk EG003
Drug-induced liver injury	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0021 affected398 at risk EG003
Hepatotoxicity	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0011 affected882 at risk EG0020 affected398 at risk EG003
Jaundice	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Contrast media allergy	Immune system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0011 affected882 at risk EG0020 affected398 at risk EG003
Drug hypersensitivity	Immune system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Abscess limb	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0021 affected398 at risk EG003
Anal abscess	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Appendiceal abscess	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Appendicitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected442 at risk EG0015 affected882 at risk EG0022 affected398 at risk EG003
Arthritis bacterial	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Arthritis infective	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Bacterial pyelonephritis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0021 affected398 at risk EG003
Bronchitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0022 affected398 at risk EG003
Bursitis infective	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Cellulitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0011 affected882 at risk EG0020 affected398 at risk EG003
Cellulitis staphylococcal	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Chronic sinusitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0011 affected882 at risk EG0021 affected398 at risk EG003
Clostridial infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Clostridium difficile colitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Cystitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Diverticulitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0021 affected398 at risk EG003
Endocarditis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Erysipelas	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Escherichia sepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Gastroenteritis bacterial	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Groin abscess	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0021 affected398 at risk EG003
Herpes zoster	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Infective spondylitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Joint abscess	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Meningitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Ophthalmic herpes simplex	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Osteomyelitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Pneumonia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0013 affected882 at risk EG0022 affected398 at risk EG003
Pneumonia bacterial	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Postoperative wound infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0011 affected882 at risk EG0021 affected398 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0011 affected882 at risk EG0020 affected398 at risk EG003
Rocky mountain spotted fever	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Sepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0011 affected882 at risk EG0020 affected398 at risk EG003
Skin infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Streptococcal sepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Subcutaneous abscess	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Anaesthetic complication	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Cardiac contusion	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0021 affected398 at risk EG003
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0021 affected398 at risk EG003
Concussion	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0011 affected882 at risk EG0021 affected398 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0011 affected882 at risk EG0020 affected398 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0021 affected398 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0022 affected398 at risk EG003
Foot fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0022 affected398 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Intervertebral disc injury	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0011 affected882 at risk EG0020 affected398 at risk EG003
Laceration	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0021 affected398 at risk EG003
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0012 affected882 at risk EG0020 affected398 at risk EG003
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0011 affected882 at risk EG0020 affected398 at risk EG003
Meniscus injury	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Multiple fractures	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Muscle rupture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0011 affected882 at risk EG0020 affected398 at risk EG003
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0011 affected882 at risk EG0020 affected398 at risk EG003
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Post procedural haematuria	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 affected442 at risk EG0010 affected882 at risk EG0021 affected398 at risk EG003
Procedural complication	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Procedural nausea	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Procedural vomiting	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Pubis fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0011 affected882 at risk EG0020 affected398 at risk EG003
Pulmonary contusion	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0021 affected398 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0022 affected398 at risk EG003
Scapula fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0011 affected882 at risk EG0020 affected398 at risk EG003
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0021 affected398 at risk EG003
Tendon injury	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Tendon rupture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0011 affected882 at risk EG0020 affected398 at risk EG003
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0021 affected398 at risk EG003
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Traumatic intracranial haemorrhage	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Ulna fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0021 affected398 at risk EG003
Urinary retention postoperative	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Wound	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0021 affected398 at risk EG003
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0021 affected398 at risk EG003
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0021 affected398 at risk EG003
Electrocardiogram ST segment abnormal	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0011 affected882 at risk EG0020 affected398 at risk EG003
HIV test positive	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Heart rate increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0021 affected398 at risk EG003
Hepatic enzyme increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0021 affected398 at risk EG003
Platelet count decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Weight decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0013 affected882 at risk EG0022 affected398 at risk EG003
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Fluid retention	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0021 affected398 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0011 affected882 at risk EG0020 affected398 at risk EG003
Malnutrition	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0011 affected882 at risk EG0020 affected398 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0021 affected398 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0021 affected398 at risk EG003
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0011 affected882 at risk EG0021 affected398 at risk EG003
Chondrocalcinosis pyrophosphate	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0021 affected398 at risk EG003
Chondropathy	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0011 affected882 at risk EG0022 affected398 at risk EG003
Dupuytren's contracture	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0021 affected398 at risk EG003
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Intervertebral disc disorder	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0011 affected882 at risk EG0020 affected398 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0022 affected398 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0021 affected398 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0011 affected882 at risk EG0020 affected398 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0011 affected882 at risk EG0020 affected398 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected442 at risk EG0013 affected882 at risk EG0025 affected398 at risk EG003
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0021 affected398 at risk EG003
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0021 affected398 at risk EG003
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0011 affected882 at risk EG0020 affected398 at risk EG003
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0021 affected398 at risk EG003
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Acute leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Adenocarcinoma gastric	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0021 affected398 at risk EG003
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Adenoma benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Anal squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0022 affected398 at risk EG003
Benign neoplasm of bladder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0021 affected398 at risk EG003
Bladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 affected442 at risk EG0010 affected882 at risk EG0021 affected398 at risk EG003
Cholangiocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Chronic lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0021 affected398 at risk EG003
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 affected442 at risk EG0010 affected882 at risk EG0022 affected398 at risk EG003
Diffuse large B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0021 affected398 at risk EG003
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0011 affected882 at risk EG0020 affected398 at risk EG003
Hairy cell leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Hepatic cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Intraductal papilloma of breast	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0011 affected882 at risk EG0020 affected398 at risk EG003
Intraductal proliferative breast lesion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0011 affected882 at risk EG0020 affected398 at risk EG003
Kaposi's sarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0021 affected398 at risk EG003
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0011 affected882 at risk EG0020 affected398 at risk EG003
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Mantle cell lymphoma stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Metastases to lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Metastases to lymph nodes	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Myxoid liposarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Oesophageal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Papillary thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0011 affected882 at risk EG0022 affected398 at risk EG003
Rectal adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0021 affected398 at risk EG003
Small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0021 affected398 at risk EG003
Small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0021 affected398 at risk EG003
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0011 affected882 at risk EG0020 affected398 at risk EG003
Squamous cell carcinoma of lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Thyroid adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0011 affected882 at risk EG0020 affected398 at risk EG003
Uterine cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0011 affected882 at risk EG0021 affected398 at risk EG003
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 affected442 at risk EG0010 affected882 at risk EG0021 affected398 at risk EG003
Ataxia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Brain stem haemorrhage	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Carotid artery stenosis	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0011 affected882 at risk EG0020 affected398 at risk EG003
Cerebral thrombosis	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0021 affected398 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0021 affected398 at risk EG003
Cervical radiculopathy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0021 affected398 at risk EG003
Dizziness	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected442 at risk EG0010 affected882 at risk EG0022 affected398 at risk EG003
Dizziness postural	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Encephalopathy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0021 affected398 at risk EG003
Facial paralysis	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Generalised tonic-clonic seizure	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Guillain-Barre syndrome	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0021 affected398 at risk EG003
Haemorrhage intracranial	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0021 affected398 at risk EG003
Headache	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0021 affected398 at risk EG003
Lumbar radiculopathy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0021 affected398 at risk EG003
Migraine	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0011 affected882 at risk EG0020 affected398 at risk EG003
Motor neurone disease	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Myelopathy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Presyncope	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0012 affected882 at risk EG0020 affected398 at risk EG003
Sciatica	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Spinal claudication	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Syncope	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0012 affected882 at risk EG0020 affected398 at risk EG003
Tension headache	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0021 affected398 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Tremor	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Trigeminal neuralgia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Vertebrobasilar insufficiency	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0021 affected398 at risk EG003
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0011 affected882 at risk EG0020 affected398 at risk EG003
Ectopic pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0011 affected882 at risk EG0020 affected398 at risk EG003
Alcohol abuse	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0021 affected398 at risk EG003
Alcohol withdrawal syndrome	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0011 affected882 at risk EG0020 affected398 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0011 affected882 at risk EG0020 affected398 at risk EG003
Confusional state	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Delirium	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Depression	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0011 affected882 at risk EG0021 affected398 at risk EG003
Hallucination	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Mental status changes	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Psychotic disorder	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Suicidal ideation	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected442 at risk EG0011 affected882 at risk EG0020 affected398 at risk EG003
Bladder prolapse	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Calculus bladder	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Chronic kidney disease	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Hydronephrosis	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0011 affected882 at risk EG0021 affected398 at risk EG003
Renal artery stenosis	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0021 affected398 at risk EG003
Renal colic	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Ureterolithiasis	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Urinary incontinence	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0011 affected882 at risk EG0020 affected398 at risk EG003
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0012 affected882 at risk EG0020 affected398 at risk EG003
Cystocele	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Menorrhagia	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Postmenopausal haemorrhage	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Prostatitis	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Uterine prolapse	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected442 at risk EG0010 affected882 at risk EG0021 affected398 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0021 affected398 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0011 affected882 at risk EG0020 affected398 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0022 affected398 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0021 affected398 at risk EG003
Laryngeal polyp	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Pharyngeal oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0011 affected882 at risk EG0020 affected398 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected442 at risk EG0011 affected882 at risk EG0021 affected398 at risk EG003
Pulmonary granuloma	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0011 affected882 at risk EG0020 affected398 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Sinus polyp	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Vocal cord polyp	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0021 affected398 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Cholecystectomy	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Knee arthroplasty	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Medical device removal	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0021 affected398 at risk EG003
Accelerated hypertension	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0011 affected882 at risk EG0020 affected398 at risk EG003
Aortic aneurysm	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0021 affected398 at risk EG003
Aortic stenosis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0011 affected882 at risk EG0021 affected398 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Hypertension	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Hypertensive crisis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Peripheral ischaemia	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003
Peripheral vascular disorder	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected442 at risk EG0010 affected882 at risk EG0020 affected398 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00011 affected442 at risk EG00141 affected882 at risk EG00233 affected398 at risk EG00361 affected822 at risk EG00494 affected1,220 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00013 affected442 at risk EG00123 affected882 at risk EG00220 affected398 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0004 affected442 at risk EG00123 affected882 at risk EG00223 affected398 at risk EG003
Fatigue	General disorders	MedDRA 21.0	Systematic Assessment	EG0005 affected442 at risk EG00131 affected882 at risk EG00216 affected398 at risk EG003
Bronchitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00017 affected442 at risk EG00148 affected882 at risk EG00240 affected398 at risk EG003
Cystitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0009 affected442 at risk EG00115 affected882 at risk EG00225 affected398 at risk EG003
Influenza	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00024 affected442 at risk EG00157 affected882 at risk EG00247 affected398 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00064 affected442 at risk EG001148 affected882 at risk EG002122 affected398 at risk EG003
Sinusitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00015 affected442 at risk EG00132 affected882 at risk EG00231 affected398 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00029 affected442 at risk EG00172 affected882 at risk EG00257 affected398 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG00010 affected442 at risk EG00115 affected882 at risk EG00225 affected398 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0004 affected442 at risk EG0014 affected882 at risk EG00220 affected398 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG00018 affected442 at risk EG00159 affected882 at risk EG00263 affected398 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG00022 affected442 at risk EG00162 affected882 at risk EG00251 affected398 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG00010 affected442 at risk EG00125 affected882 at risk EG00221 affected398 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG00012 affected442 at risk EG00128 affected882 at risk EG00219 affected398 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0004 affected442 at risk EG00122 affected882 at risk EG00227 affected398 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG00014 affected442 at risk EG00144 affected882 at risk EG00232 affected398 at risk EG003
Dizziness	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG00012 affected442 at risk EG00118 affected882 at risk EG00220 affected398 at risk EG003
Headache	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG00012 affected442 at risk EG00154 affected882 at risk EG00228 affected398 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG00019 affected442 at risk EG00141 affected882 at risk EG00240 affected398 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG00010 affected442 at risk EG00124 affected882 at risk EG00214 affected398 at risk EG003
Hypertension	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG00020 affected442 at risk EG00152 affected882 at risk EG00240 affected398 at risk EG003

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

ID	Term
D019984	Quality Indicators, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration
D017530	Health Care Quality, Access, and Evaluation

ID	Title	Description
BG000	Standard of Care	Participants randomized to receive standard of care (SOC) treatment for the first year of the extension study (SOC-controlled period).
BG001	Evolocumab + SOC	Participants randomized to receive evolocumab 420 mg once a month plus standard of care for the first year of the extension study (SOC-controlled period).
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	SOC-controlled Period: SOC	Participants received standard of care (SOC) treatment for the first year of the study (SOC-controlled period).	2	442	30	442	217	442
EG001	SOC-controlled Period: Evolocumab + SOC	Participants received evolocumab 420 mg once a month for the first year of the study (SOC-controlled period).	1	882	72	882	513	882
EG002	All-IP Period: SOC / Evolocumab	At week 52 participants began treatment with evolocumab 420 mg QM for up to 4 years during the all-IP period.	3	398	78	398	311	398
EG003	All-IP Period: Evolocumab + SOC / Evolocumab	At week 52 participants continued treatment with evolocumab 420 mg QM for another 4 years during the all-IP period.	13	822	181	822	626	822
EG004	All-IP Period: Total	All participants in the All-IP period who received evolocumab 420 mg QM for up to 4 years.	16	1,220	259	1,220	937	1,220