Open-label Extension Study of Evolocumab (AMG 145) in Adu... | NCT01854918

NCT01854918

ID	Type	Description	Link
2012-004357-83	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

Arm Groups

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 48, participants began treatment with evolocumab at a dose of either 140 mg every 2 weeks (Q2W) or 420 mg every month (QM), based on participant choice, for approximately 2 years during the all-investigational product [all-IP] period.	Biological: Evolocumab Drug: Standard of Care
Evolocumab + Standard of Care	Experimental	Participants received subcutaneous evolocumab plus standard of care during the first year of the study (SOC-controlled period) and for approximately 2 years during the all-IP period. Evolocumab was administered at a dose of 140 mg every 2 weeks (Q2W) or 420 mg every month (QM) based on participant choice.	Biological: Evolocumab Drug: Standard of Care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Evolocumab	Biological	Administered by subcutaneous injection either every 2 weeks or once a month (patient preference) using a prefilled autoinjector pen	Evolocumab + Standard of Care

Outcomes Module

Primary Outcomes

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 4.0, 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.	48 weeks in the SOC-controlled period and up to 2 years in the All-IP period

Secondary Outcomes

Measure	Description	Time Frame
Percent Change From Baseline in LDL-C at Weeks 48 and 104		Baseline of the parent study and weeks 48 amd 104
Change From Baseline in LDL-C at Weeks 48 and 104		Baseline of the parent study and weeks 48 amd 104

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
MD	Amgen	Study Director

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

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29353350	Background	Kasichayanula S, Grover A, Emery MG, Gibbs MA, Somaratne R, Wasserman SM, Gibbs JP. Clinical Pharmacokinetics and Pharmacodynamics of Evolocumab, a PCSK9 Inhibitor. Clin Pharmacokinet. 2018 Jul;57(7):769-779. doi: 10.1007/s40262-017-0620-7.
28844508	Result	Sattar N, Toth PP, Blom DJ, Koren MJ, Soran H, Uhart M, Elliott M, Cyrille M, Somaratne R, Preiss D. Effect of the Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitor Evolocumab on Glycemia, Body Weight, and New-Onset Diabetes Mellitus. Am J Cardiol. 2017 Nov 1;120(9):1521-1527. doi: 10.1016/j.amjcard.2017.07.047. Epub 2017 Jul 31.

Label	URL
AmgenTrials clinical trials website	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Standard of Care	Participants received standard of care (SOC) treatment for the first year of the study (SOC-controlled period). At week 48, participants began treatment with evolocumab at a dose of either 140 mg every 2 weeks (Q2W) or 420 mg every month (QM), based on participant choice, for approximately 2 years during the all-investigational product [all-IP] period.

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
Prot	Yes	No	No	Study Protocol	Apr 3, 2015	May 20, 2019

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Arm/Group Information

ID	Title	Description
BG000	Standard of Care	Participants received standard of care (SOC) treatment for the first year of the study (SOC-controlled period). At week 48, participants began treatment with evolocumab at a dose of either 140 mg every 2 weeks (Q2W) or 420 mg every month (QM), based on participant choice, for approximately 2 years during the all-investigational product [all-IP] period.
BG001	Evolocumab + Standard of Care	Participants received subcutaneous evolocumab plus standard of care during the first year of the study (SOC-controlled period) and for approximately 2 years during the all-IP period. Evolocumab was administered at a dose of 140 mg every 2 weeks (Q2W) or 420 mg every month (QM) based on participant choice.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00058.8± 10.7 BG00158.6± 10.7 BG00258.7± 10.7

Age, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
< 65 years	BG000823 BG0011665 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000560 BG0011176 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00058 BG001109 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0002 BG0015 BG002

Region

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
North America	BG000514 BG0011001 BG002

Parent Study Baseline Low-density Lipoprotein Cholesterol (LDL-C) Concentration

Mean

Standard Deviation

mg/dL

Title

Denominators

Categories

Title	Measurements
	BG000125.8± 49.3 BG001127.4± 51.7 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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 4.0, 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 2-3).

Posted

Count of Participants

Participants

48 weeks in the SOC-controlled period and up to 2 years in the All-IP period

ID	Title	Description
OG000	Year 1: Standard of Care	Participants received standard of care (SOC) treatment for the first year of the study (SOC-controlled period).
OG001	Year 1: Evolocumab + Standard of Care	Participants received subcutaneous evolocumab plus standard of care during the first year of the study (SOC-controlled period). Evolocumab was administered at a dose of 140 mg every 2 weeks (Q2W) or 420 mg every month (QM) based on participant choice.
OG002	Years 2-3: SOC / Evolocumab + SOC	At week 48, participants began treatment with evolocumab at a dose of either 140 mg Q2W or 420 mg QM, based on participant choice, plus SOC, for approximately 2 years during the all-IP period.
OG003	Years 2-3: Evolocumab + SOC / Evolocumab + SOC	Participants continued to receive evolocumab plus SOC for approximately 2 years during the all-IP period. Evolocumab was administered at a dose of 140 mg Q2W or 420 mg QM based on participant choice.

Units	Counts
Participants	OG0001227 OG0012454 OG0021152 OG003

Title

Denominators

Categories

All adverse events

Title	Measurements
	OG000796 OG0011655 OG002929 OG003

Secondary

Percent Change From Baseline in LDL-C at Weeks 48 and 104

Participants who were randomized in 20120138 and on-study and with known dosing information in the All-IP period, and with non-missing data at each time point.

Posted

Mean

Standard Deviation

percent change

Baseline of the parent study and weeks 48 amd 104

ID	Title	Description
OG000	Standard of Care	Participants received standard of care (SOC) treatment for the first year of the study (SOC-controlled period). At week 48, participants began treatment with evolocumab at a dose of either 140 mg every 2 weeks (Q2W) or 420 mg every month (QM), based on participant choice, for approximately 2 years during the all-investigational product [all-IP] period.
OG001	Evolocumab + Standard of Care	Participants received subcutaneous evolocumab plus standard of care during the first year of the study (SOC-controlled period) and for approximately 2 years during the all-IP period. Evolocumab was administered at a dose of 140 mg every 2 weeks (Q2W) or 420 mg every month (QM) based on participant choice.

Units	Counts
Participants

Secondary

Change From Baseline in LDL-C at Weeks 48 and 104

Participants who were randomized in 20120138 and on-study and with known dosing information in the All-IP period, and with non-missing data at each time point.

Posted

Mean

Standard Deviation

mg/dL

Baseline of the parent study and weeks 48 amd 104

ID	Title	Description
OG000	Standard of Care	Participants received standard of care (SOC) treatment for the first year of the study (SOC-controlled period). At week 48, participants began treatment with evolocumab at a dose of either 140 mg every 2 weeks (Q2W) or 420 mg every month (QM), based on participant choice, for approximately 2 years during the all-investigational product [all-IP] period.
OG001	Evolocumab + Standard of Care	Participants received subcutaneous evolocumab plus standard of care during the first year of the study (SOC-controlled period) and for approximately 2 years during the all-IP period. Evolocumab was administered at a dose of 140 mg every 2 weeks (Q2W) or 420 mg every month (QM) based on participant choice.

Units	Counts
Participants

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	Year 1: Standard of Care	Participants received standard of care (SOC) treatment for the first year of the study (SOC-controlled period).	5	1,227	104	1,227	334	1,227
EG001	Year 1: Evolocumab + Standard of Care	Participants received subcutaneous evolocumab plus standard of care during the first year of the study (SOC-controlled period). Evolocumab was administered at a dose of 140 mg every 2 weeks (Q2W) or 420 mg every month (QM) based on participant choice.	5	2,454	195	2,454	681	2,454
EG002	Years 2-3: SOC / Evolocumab + SOC	At week 48, participants began treatment with evolocumab at a dose of either 140 mg Q2W or 420 mg QM, based on participant choice, plus SOC, for approximately 2 years during the all-IP period.	5	1,197	181	1,197	498	1,197
EG003	Years 2-3: Evolocumab + SOC / Evolocumab + SOC	Participants continued to receive evolocumab plus SOC for approximately 2 years during the all-IP period. Evolocumab was administered at a dose of 140 mg Q2W or 420 mg QM based on participant choice.	16	2,391	344	2,391	928	2,391
EG004	Years 2-3: Total	All participants in the All-IP period who received evolocumab plus SOC for approximately 2 years. Evolocumab was administered at a dose of 140 mg Q2W or 420 mg QM based on participant choice.	21	3,588	525	3,588	1,426	3,588

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0021 affected1,197 at risk EG0031 affected2,391 at risk EG0042 affected3,588 at risk
Haemolysis	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Thrombocytopenic purpura	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Acute coronary syndrome	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0004 affected1,227 at risk EG0018 affected2,454 at risk EG0023 affected1,197 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0017 affected2,454 at risk EG00210 affected1,197 at risk EG003
Angina unstable	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0006 affected1,227 at risk EG0017 affected2,454 at risk EG0024 affected1,197 at risk EG003
Aortic valve disease	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Aortic valve incompetence	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Aortic valve sclerosis	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Aortic valve stenosis	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Arrhythmia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0003 affected1,227 at risk EG0011 affected2,454 at risk EG0027 affected1,197 at risk EG003
Atrial flutter	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Atrioventricular block	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Bradycardia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Cardiac failure acute	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0023 affected1,197 at risk EG003
Cardio-respiratory arrest	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0004 affected1,227 at risk EG0013 affected2,454 at risk EG0022 affected1,197 at risk EG003
Coronary artery occlusion	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Coronary artery stenosis	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0012 affected2,454 at risk EG0021 affected1,197 at risk EG003
Left ventricular failure	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Mitral valve incompetence	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected1,227 at risk EG0015 affected2,454 at risk EG0020 affected1,197 at risk EG003
Myocardial ischaemia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Palpitations	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Pericardial effusion	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Pericarditis	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Rheumatic heart disease	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Sinus node dysfunction	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0010 affected2,454 at risk EG0022 affected1,197 at risk EG003
Supraventricular tachycardia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Tachycardia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Tricuspid valve incompetence	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Ventricular extrasystoles	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0021 affected1,197 at risk EG003
Ventricular fibrillation	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Ventricular tachycardia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0012 affected2,454 at risk EG0020 affected1,197 at risk EG003
Adenomatous polyposis coli	Congenital, familial and genetic disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Deafness neurosensory	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Tinnitus	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0012 affected2,454 at risk EG0020 affected1,197 at risk EG003
Vertigo positional	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Goitre	Endocrine disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Hyperparathyroidism primary	Endocrine disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Hyperthyroidism	Endocrine disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Hypothyroidism	Endocrine disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Blindness transient	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Cataract	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0011 affected2,454 at risk EG0021 affected1,197 at risk EG003
Macular fibrosis	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Retinal vein occlusion	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Abdominal hernia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0013 affected2,454 at risk EG0020 affected1,197 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Anal skin tags	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Colitis ischaemic	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Diverticulum intestinal	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Duodenitis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Enterovesical fistula	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Gastric haemorrhage	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Gastric ulcer	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0022 affected1,197 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Gastroduodenal ulcer	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0021 affected1,197 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Hiatus hernia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0021 affected1,197 at risk EG003
Ileus	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Incarcerated inguinal hernia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0012 affected2,454 at risk EG0023 affected1,197 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Intestinal perforation	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Intra-abdominal haematoma	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Intussusception	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Large intestinal obstruction	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Large intestine perforation	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Large intestine polyp	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0011 affected2,454 at risk EG0021 affected1,197 at risk EG003
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Mechanical ileus	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Oesophageal ulcer	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Oesophageal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Oesophagitis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0011 affected2,454 at risk EG0021 affected1,197 at risk EG003
Salivary gland calculus	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Short-bowel syndrome	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Umbilical hernia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Asthenia	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Chest discomfort	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Chest pain	General disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected1,227 at risk EG0011 affected2,454 at risk EG0023 affected1,197 at risk EG003
Complication associated with device	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Face oedema	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Fatigue	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Gait disturbance	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0012 affected2,454 at risk EG0021 affected1,197 at risk EG003
Impaired healing	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Injection site erythema	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Malaise	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Multiple organ dysfunction syndrome	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 21.0	Systematic Assessment	EG0003 affected1,227 at risk EG0014 affected2,454 at risk EG00210 affected1,197 at risk EG003
Oedema peripheral	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Pain	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Polyp	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Pyrexia	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Sudden death	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Vascular stent occlusion	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Vascular stent stenosis	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Bile duct stenosis	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Bile duct stone	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Cholangitis	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0023 affected1,197 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0023 affected1,197 at risk EG003
Cholecystitis chronic	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0013 affected2,454 at risk EG0025 affected1,197 at risk EG003
Gallbladder necrosis	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Non-alcoholic fatty liver	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Sphincter of Oddi dysfunction	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Allergy to arthropod sting	Immune system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0012 affected2,454 at risk EG0020 affected1,197 at risk EG003
Anaphylactic reaction	Immune system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Contrast media allergy	Immune system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Drug hypersensitivity	Immune system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Abdominal abscess	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Abscess jaw	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Abscess neck	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Appendicitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Appendicitis perforated	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Arthritis bacterial	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Bronchitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Bronchopulmonary aspergillosis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Campylobacter infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Cellulitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0023 affected1,197 at risk EG003
Clostridium difficile infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Cystitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0012 affected2,454 at risk EG0020 affected1,197 at risk EG003
Device related infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Diverticulitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 affected1,227 at risk EG0011 affected2,454 at risk EG0022 affected1,197 at risk EG003
Endocarditis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Epididymitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0021 affected1,197 at risk EG003
Gastroenteritis bacterial	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Haematoma infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Hepatitis B	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Herpes zoster	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Infected dermal cyst	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Influenza	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Intervertebral discitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Liver abscess	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Localised infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0012 affected2,454 at risk EG0020 affected1,197 at risk EG003
Meningitis viral	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Neurosyphilis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Osteomyelitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Otitis externa	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Parotitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Pelvic inflammatory disease	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Peritonitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Pneumonia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0010 affected2,454 at risk EG0024 affected1,197 at risk EG003
Pneumonia pneumococcal	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Pneumonia viral	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Post procedural infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Postoperative abscess	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Postoperative wound infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Pyelitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Pyelonephritis acute	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Sepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0021 affected1,197 at risk EG003
Septic shock	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Sinusitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Staphylococcal infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Tonsillitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0021 affected1,197 at risk EG003
Urosepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0012 affected2,454 at risk EG0020 affected1,197 at risk EG003
Accidental overdose	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Alcohol poisoning	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Anaemia postoperative	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Anastomotic complication	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0012 affected2,454 at risk EG0022 affected1,197 at risk EG003
Back injury	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Cartilage injury	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Comminuted fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Concussion	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Face injury	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0010 affected2,454 at risk EG0022 affected1,197 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Fibula fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Foot fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Fractured coccyx	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Gastroenteritis radiation	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Incision site haematoma	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Incisional hernia	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Intestinal anastomosis complication	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Jaw fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Laceration	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Meniscus injury	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0012 affected2,454 at risk EG0021 affected1,197 at risk EG003
Multiple fractures	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Overdose	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Patella fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Post procedural fever	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Radius fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0021 affected1,197 at risk EG003
Spinal fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0022 affected1,197 at risk EG003
Subarachnoid haemorrhage	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Subdural haemorrhage	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Tendon rupture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Thermal burn	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0022 affected1,197 at risk EG003
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
VIIIth nerve injury	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Vascular graft complication	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Vascular graft stenosis	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0022 affected1,197 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Anticoagulation drug level below therapeutic	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Antimitochondrial antibody positive	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Antinuclear antibody	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Blood immunoglobulin M increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Ejection fraction decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Intraocular pressure increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Liver function test abnormal	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Red blood cell sedimentation rate increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Scan myocardial perfusion abnormal	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Fluid overload	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Gout	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Obesity	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0012 affected2,454 at risk EG0021 affected1,197 at risk EG003
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Diffuse idiopathic skeletal hyperostosis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Dupuytren's contracture	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Femoroacetabular impingement	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Fibromyalgia	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Fracture nonunion	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Gouty arthritis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0011 affected2,454 at risk EG0026 affected1,197 at risk EG003
Joint effusion	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Knee deformity	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0022 affected1,197 at risk EG003
Metatarsalgia	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Muscle haemorrhage	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0005 affected1,227 at risk EG00112 affected2,454 at risk EG00222 affected1,197 at risk EG003
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Polymyalgia rheumatica	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0022 affected1,197 at risk EG003
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0021 affected1,197 at risk EG003
Spinal deformity	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Tendon disorder	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Vertebral foraminal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0012 affected2,454 at risk EG0021 affected1,197 at risk EG003
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Benign anorectal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Bladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0013 affected2,454 at risk EG0020 affected1,197 at risk EG003
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0004 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Breast cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Breast neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Cervix carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Chronic lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Diffuse large B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Duodenal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Essential thrombocythaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Intraductal proliferative breast lesion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0011 affected2,454 at risk EG0021 affected1,197 at risk EG003
Invasive breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0022 affected1,197 at risk EG003
Invasive papillary breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Laryngeal squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Lung adenocarcinoma stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Malignant melanoma in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Metastases to peritoneum	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Neoplasm of appendix	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Neuroendocrine carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Non-Hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Oral papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Pancreatic carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Papillary thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Papillary tumour of renal pelvis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Penile neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0002 affected1,227 at risk EG0013 affected2,454 at risk EG0023 affected1,197 at risk EG003
Rectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Salivary gland adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Salivary gland cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Squamous cell carcinoma of lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Squamous cell carcinoma of the vulva	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Testicular seminoma (pure)	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Thyroid adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Thyroid neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Tongue neoplasm malignant stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Uterine cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Vulval cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Ataxia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Carotid artery aneurysm	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Carotid artery stenosis	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0012 affected2,454 at risk EG0020 affected1,197 at risk EG003
Carpal tunnel syndrome	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Cerebellar haemorrhage	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Cerebral haemorrhage	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Cerebral ischaemia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0011 affected2,454 at risk EG0021 affected1,197 at risk EG003
Cervical radiculopathy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Dizziness	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Dysaesthesia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Epilepsy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Haemorrhage intracranial	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Haemorrhagic stroke	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Headache	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Hydrocephalus	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Hypoglycaemic seizure	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Intracranial aneurysm	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Ischaemic stroke	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Lacunar infarction	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Lumbar radiculopathy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Metabolic encephalopathy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Migraine	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Myelopathy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Nerve root compression	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Paresis	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Polyneuropathy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Presyncope	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Sciatica	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Seizure	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0012 affected2,454 at risk EG0020 affected1,197 at risk EG003
Spinal cord haematoma	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Syncope	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0003 affected1,227 at risk EG0011 affected2,454 at risk EG0022 affected1,197 at risk EG003
Transient global amnesia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0003 affected1,227 at risk EG0010 affected2,454 at risk EG0023 affected1,197 at risk EG003
Tremor	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Vertebrobasilar insufficiency	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Visual field defect	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Device leakage	Product Issues	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Adjustment disorder with depressed mood	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Agoraphobia	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Alcoholism	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0021 affected1,197 at risk EG003
Bipolar I disorder	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Bipolar disorder	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Completed suicide	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Confusional state	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Depression	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Drug dependence	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Psychotic disorder	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Schizophrenia	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Suicidal ideation	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Suicide attempt	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Bladder fibrosis	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Calculus bladder	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Calculus urinary	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0021 affected1,197 at risk EG003
Chronic kidney disease	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Hydronephrosis	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0014 affected2,454 at risk EG0021 affected1,197 at risk EG003
Renal artery stenosis	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Renal cyst	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Renal impairment	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Renal infarct	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Ureteral spasm	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Ureteric stenosis	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Ureterolithiasis	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0013 affected2,454 at risk EG0020 affected1,197 at risk EG003
Urethral stenosis	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Urinary incontinence	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0012 affected2,454 at risk EG0023 affected1,197 at risk EG003
Cystocele	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Genital prolapse	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Mastoptosis	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Ovarian cyst	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0022 affected1,197 at risk EG003
Prostatic obstruction	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Prostatism	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Prostatitis	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Rectocele	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Uterine haemorrhage	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Uterine polyp	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Uterine prolapse	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0021 affected1,197 at risk EG003
Vaginal prolapse	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0021 affected1,197 at risk EG003
Acquired diaphragmatic eventration	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0021 affected1,197 at risk EG003
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Bronchostenosis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0022 affected1,197 at risk EG003
Diaphragmatic paralysis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Nasal polyps	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Nasal septum deviation	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0021 affected1,197 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Vocal cord polyp	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Toxic skin eruption	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Accelerated hypertension	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Aortic aneurysm	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0012 affected2,454 at risk EG0021 affected1,197 at risk EG003
Aortic dilatation	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Aortic dissection	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Aortic stenosis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0024 affected1,197 at risk EG003
Arteriosclerosis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Artery dissection	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Blood pressure fluctuation	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Haematoma	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Hypertension	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected1,227 at risk EG0011 affected2,454 at risk EG0021 affected1,197 at risk EG003
Hypertensive crisis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Hypertensive emergency	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Hypotension	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Labile blood pressure	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Malignant hypertension	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Microangiopathy	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Orthostatic hypotension	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0022 affected1,197 at risk EG003
Pelvic venous thrombosis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0012 affected2,454 at risk EG0020 affected1,197 at risk EG003
Peripheral artery aneurysm	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0011 affected2,454 at risk EG0020 affected1,197 at risk EG003
Peripheral artery occlusion	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Peripheral ischaemia	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Peripheral vascular disorder	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Subclavian artery stenosis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Thrombophlebitis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Varicose vein	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0020 affected1,197 at risk EG003
Venous thrombosis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003
Venous thrombosis limb	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected1,227 at risk EG0010 affected2,454 at risk EG0021 affected1,197 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Bronchitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00043 affected1,227 at risk EG00178 affected2,454 at risk EG00270 affected1,197 at risk EG003132 affected2,391 at risk EG004202 affected3,588 at risk
Influenza	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00028 affected1,227 at risk EG00166 affected2,454 at risk EG00260 affected1,197 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG000108 affected1,227 at risk EG001201 affected2,454 at risk EG002151 affected1,197 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00055 affected1,227 at risk EG001104 affected2,454 at risk EG00299 affected1,197 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG00038 affected1,227 at risk EG001106 affected2,454 at risk EG00280 affected1,197 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG00035 affected1,227 at risk EG00183 affected2,454 at risk EG00278 affected1,197 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG00043 affected1,227 at risk EG00188 affected2,454 at risk EG00261 affected1,197 at risk EG003
Hypertension	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG00056 affected1,227 at risk EG00187 affected2,454 at risk EG00278 affected1,197 at risk EG003

ID	Term
D006949	Hyperlipidemias
D006937	Hypercholesterolemia

ID	Term
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