Outcomes Study to Assess STatin Residual Risk Reduction W... | NCT02104817

NCT02104817

ID	Type	Description	Link
2014-001069-28	EudraCT Number

Status Module

Name	Class
The Cleveland Clinic	OTHER
IQVIA RDS Inc.	INDUSTRY

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
EPANOVA	Experimental	Epanova + statin, once daily	Drug: Epanova® (omega-3 carboxylic acids)
Corn oil	Active Comparator	Corn oil + Statin	Drug: corn oil control

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Epanova® (omega-3 carboxylic acids)	Drug	Adjunct to statin therapy and diet in high risk adult patients for the prevention and reduction of major adverse cardiovascular events (MACE)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The Composite of Major Adverse Cardiovascular Events (MACE)	MACE components include: cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, emergent/elective coronary revascularization, or hospitalization for unstable angina. Participants with no observed events are censored at the earliest of withdrawal of consent date and last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed).	From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure

Secondary Outcomes

Measure	Description	Time Frame
The Composite of MACE in the Subgroup of Participants With Established CV Disease(CVD) at Baseline	MACE components include: cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, emergent/elective coronary revascularization, or hospitalization for unstable angina. Participants with no observed events are censored at the earliest of withdrawal of consent date and last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed).

Other Outcomes

Measure	Description	Time Frame
Emergent/Elective Coronary Revascularization	Participants with no observed events are censored at the earliest of withdrawal of consent date and last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed).	From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure

Eligibility Module

Contacts/Locations Module

Overall Officials

Name	Affiliation	Role
Steven Nissen, MD	The Cleveland Clinic	Principal Investigator
Michael Lincoff, MD	The Cleveland Clinic	Principal Investigator
Stephen Nicholls, MD	MonashHeart	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Birmingham	Alabama	35205	United States
Research Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33993205	Derived	Nissen SE, Lincoff AM, Wolski K, Ballantyne CM, Kastelein JJP, Ridker PM, Ray KK, McGuire DK, Mozaffarian D, Koenig W, Davidson MH, Garcia M, Katona BG, Himmelmann A, Loss LE, Poole M, Menon V, Nicholls SJ. Association Between Achieved omega-3 Fatty Acid Levels and Major Adverse Cardiovascular Outcomes in Patients With High Cardiovascular Risk: A Secondary Analysis of the STRENGTH Trial. JAMA Cardiol. 2021 Aug 1;6(8):910-917. doi: 10.1001/jamacardio.2021.1157.
33190147

Label	URL
redacted CSP	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

ID	Title	Description
FG000	Epanova	Omega-3 carboxylic acid 4 x 1 gram capsule
FG001	Placebo	Corn oil 4 x 1 gram capsule

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	May 1, 2015	May 25, 2021

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
	BG00062.5± 8.98 BG00162.5± 8.98 BG00262.5± 8.98

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0002289 BG0012279 BG002

Race/Ethnicity, Customized

Number

Participants

Title

Denominators

Categories

WHITE

Title	Measurements
	BG0005341 BG0015382 BG002

Region of Enrollment

Number

Participants

Title

Denominators

Categories

Australia

Title	Measurements
	BG00058 BG00154 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

The Composite of Major Adverse Cardiovascular Events (MACE)

MACE components include: cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, emergent/elective coronary revascularization, or hospitalization for unstable angina. Participants with no observed events are censored at the earliest of withdrawal of consent date and last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed).

Full Analysis Set

Posted

Number

Number of Participants

From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure

ID	Title	Description
OG000	Epanova	Omega-3 carboxylic acid 4 x 1 gram capsule
OG001	Placebo	Corn oil 4 x 1 gram capsule

Units	Counts
Participants	OG0006539 OG0016539

Title

Denominators

Categories

Title	Measurements
	OG000785 OG001795

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Regression, Cox		0.837	The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing.	Hazard Ratio (HR)	0.99			2-Sided	95	0.90	1.09					Superiority

Secondary

The Composite of MACE in the Subgroup of Participants With Established CV Disease(CVD) at Baseline

Full Analysis Set

Posted

Number

Number of Participants

From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure

ID	Title	Description
OG000	Epanova	Omega-3 carboxylic acid 4 x 1 gram capsule
OG001	Placebo	Corn oil 4 x 1 gram capsule

Units	Counts
Participants	OG000

Secondary

The Composite of CV Events

CV events include: cardiovascular (CV) death, non-fatal myocardial infarction (MI) and non-fatal stroke. Participants with no observed events are censored at the earliest of withdrawal of consent date and last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed).

Full Analysis Set

Posted

Number

Number of Participants

From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure

ID	Title	Description
OG000	Epanova	Omega-3 carboxylic acid 4 x 1 gram capsule
OG001	Placebo	Corn oil 4 x 1 gram capsule

Units	Counts
Participants	OG000

Secondary

The Composite of CV Events in the Subgroup of Participants With Established CV Disease (CVD) at Baseline

Full Analysis Set

Posted

Number

Number of Participants

From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure

ID	Title	Description
OG000	Epanova	Omega-3 carboxylic acid 4 x 1 gram capsule
OG001	Placebo	Corn oil 4 x 1 gram capsule

Units	Counts
Participants	OG000

Secondary

The Composite of Coronary Events

Coronary events include: cardiac death (including death due to acute myocardial infarction, sudden cardiac death and death due to cardiovascular procedures), non-fatal myocardial infarction (MI), emergent/elective coronary revascularization and hospitalization for unstable angina. Participants with no observed events are censored at the earliest of withdrawal of consent date and last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed).

Full Analysis Set

Posted

Number

Number of Participants

From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure

ID	Title	Description
OG000	Epanova	Omega-3 carboxylic acid 4 x 1 gram capsule
OG001	Placebo	Corn oil 4 x 1 gram capsule

Units	Counts
Participants

Secondary

The Composite of Coronary Events in the Subgroup of Participants With Established CVD at Baseline

Full Analysis Set

Posted

Number

Number of Participants

From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure

ID	Title	Description
OG000	Epanova	Omega-3 carboxylic acid 4 x 1 gram capsule
OG001	Placebo	Corn oil 4 x 1 gram capsule

Units	Counts
Participants

Secondary

CV Death

Participants with no observed events are censored at the latest of the date of last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed), last date known to be alive, and date of non-cardiovascular death.

Posted

Number

Number of Participants

From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure

ID	Title	Description
OG000	Epanova	Omega-3 carboxylic acid 4 x 1 gram capsule
OG001	Placebo	Corn oil 4 x 1 gram capsule

Units	Counts
Participants	OG000

Secondary

CV Death in the Subgroup of Participants With Established CVD at Baseline

Full Analysis Set

Posted

Number

Number of Participants

From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure

ID	Title	Description
OG000	Epanova	Omega-3 carboxylic acid 4 x 1 gram capsule
OG001	Placebo	Corn oil 4 x 1 gram capsule

Units	Counts
Participants	OG000

Secondary

All-cause Death

Full Analysis Set

Posted

Number

Number of Participants

From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure

ID	Title	Description
OG000	Epanova	Omega-3 carboxylic acid 4 x 1 gram capsule
OG001	Placebo	Corn oil 4 x 1 gram capsule

Units	Counts
Participants	OG000

Secondary

All-cause Death in the Subgroup of Participants With Established CVD at Baseline

Participants with no observed events are censored at the latest of the date of last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed) and last date known to be alive in the subgroup of participants with established CVD at baseline

Full Analysis Set

Posted

Number

Number of Participants

From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure

ID	Title	Description
OG000	Epanova	Omega-3 carboxylic acid 4 x 1 gram capsule
OG001	Placebo	Corn oil 4 x 1 gram capsule

Units	Counts
Participants	OG000

Other Pre-specified

Emergent/Elective Coronary Revascularization

Participants with no observed events are censored at the earliest of withdrawal of consent date and last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed).

Full Analysis Set

Posted

Number

Number of Participants

From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure

ID	Title	Description
OG000	Epanova	Omega-3 carboxylic acid 4 x 1 gram capsule
OG001	Placebo	Corn oil 4 x 1 gram capsule

Units	Counts
Participants	OG000

Other Pre-specified

Hospitalization for Unstable Angina

Full Analysis Set

Posted

Number

Number of Participants

From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure

ID	Title	Description
OG000	Epanova	Omega-3 carboxylic acid 4 x 1 gram capsule
OG001	Placebo	Corn oil 4 x 1 gram capsule

Units	Counts
Participants	OG000

Other Pre-specified

Non-fatal Myocardial Infarction

Full Analysis Set

Posted

Number

Number of Participants

From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure

ID	Title	Description
OG000	Epanova	Omega-3 carboxylic acid 4 x 1 gram capsule
OG001	Placebo	Corn oil 4 x 1 gram capsule

Units	Counts
Participants	OG000

Other Pre-specified

Non-fatal Stroke

Full Analysis Set

Posted

Number

Number of Participants

From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure

ID	Title	Description
OG000	Epanova	Omega-3 carboxylic acid 4 x 1 gram capsule
OG001	Placebo	Corn oil 4 x 1 gram capsule

Units	Counts
Participants	OG000

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	Epanova	Omega-3 carboxylic acid 4 x 1 gram capsule	373	6,539	2,259	6,532	1,405	6,532
EG001	Placebo	Corn oil 4 x 1 gram capsule	333	6,539	2,195	6,535	826	6,535

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Agranulocytosis	Blood and lymphatic system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 22.1	Systematic Assessment	EG00017 events15 affected6,532 at risk EG00125 events19 affected6,535 at risk
Anaemia macrocytic	Blood and lymphatic system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Antiphospholipid syndrome	Blood and lymphatic system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Blood loss anaemia	Blood and lymphatic system disorders	MedDRA 22.1	Systematic Assessment	EG0009 events9 affected6,532 at risk EG0016 events6 affected6,535 at risk
Coagulopathy	Blood and lymphatic system disorders	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected6,532 at risk EG0010 events0 affected6,535 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Immune thrombocytopenic purpura	Blood and lymphatic system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 22.1	Systematic Assessment	EG00010 events9 affected6,532 at risk EG0016 events6 affected6,535 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0012 events2 affected6,535 at risk
Microcytic anaemia	Blood and lymphatic system disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0011 events1 affected6,535 at risk
Nephrogenic anaemia	Blood and lymphatic system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Normocytic anaemia	Blood and lymphatic system disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0011 events1 affected6,535 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Polycythaemia	Blood and lymphatic system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Splenic infarction	Blood and lymphatic system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Splenic thrombosis	Blood and lymphatic system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Splenomegaly	Blood and lymphatic system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected6,532 at risk EG0016 events3 affected6,535 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG00013 events13 affected6,532 at risk EG0018 events8 affected6,535 at risk
Acute left ventricular failure	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG00016 events16 affected6,532 at risk EG0019 events8 affected6,535 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG00053 events40 affected6,532 at risk EG00147 events45 affected6,535 at risk
Adams-stokes syndrome	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0012 events2 affected6,535 at risk
Angina pectoris	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG000110 events92 affected6,532 at risk EG001113 events102 affected6,535 at risk
Angina unstable	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG000125 events112 affected6,532 at risk EG001162 events141 affected6,535 at risk
Anginal equivalent	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Aortic valve disease	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0013 events2 affected6,535 at risk
Aortic valve incompetence	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0012 events2 affected6,535 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0008 events6 affected6,532 at risk EG0013 events3 affected6,535 at risk
Arrhythmia	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG00012 events12 affected6,532 at risk EG0015 events5 affected6,535 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG00023 events19 affected6,532 at risk EG00120 events15 affected6,535 at risk
Arteriospasm coronary	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG000188 events150 affected6,532 at risk EG001103 events89 affected6,535 at risk
Atrial flutter	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG00020 events14 affected6,532 at risk EG00120 events17 affected6,535 at risk
Atrial tachycardia	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0003 events2 affected6,532 at risk EG0015 events3 affected6,535 at risk
Atrioventricular block	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0011 events1 affected6,535 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0007 events7 affected6,532 at risk EG0017 events7 affected6,535 at risk
Atrioventricular block first degree	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Atrioventricular block second degree	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0004 events4 affected6,532 at risk EG0014 events4 affected6,535 at risk
Atrioventricular dissociation	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Bradyarrhythmia	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Bradycardia	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0008 events8 affected6,532 at risk EG00110 events9 affected6,535 at risk
Cardiac aneurysm	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Cardiac arrest	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG00019 events19 affected6,532 at risk EG00111 events11 affected6,535 at risk
Cardiac asthma	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Cardiac discomfort	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Cardiac disorder	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Cardiac failure	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG000117 events90 affected6,532 at risk EG001132 events92 affected6,535 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG00035 events27 affected6,532 at risk EG00125 events21 affected6,535 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG00021 events18 affected6,532 at risk EG00126 events21 affected6,535 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG00083 events60 affected6,532 at risk EG00177 events59 affected6,535 at risk
Cardiac tamponade	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Cardiac ventricular thrombosis	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Cardio-respiratory distress	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0006 events6 affected6,532 at risk EG0011 events1 affected6,535 at risk
Cardiomyopathy	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0009 events9 affected6,532 at risk EG0012 events2 affected6,535 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected6,532 at risk EG0015 events5 affected6,535 at risk
Cardiovascular deconditioning	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Cardiovascular disorder	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Cardiovascular insufficiency	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Congestive cardiomyopathy	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0012 events2 affected6,535 at risk
Coronary artery disease	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG00089 events82 affected6,532 at risk EG00172 events61 affected6,535 at risk
Coronary artery insufficiency	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected6,532 at risk EG0018 events7 affected6,535 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected6,532 at risk EG0018 events8 affected6,535 at risk
Coronary artery thrombosis	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0012 events2 affected6,535 at risk
Diastolic dysfunction	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Extrasystoles	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Hypertensive heart disease	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Intracardiac thrombus	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0005 events4 affected6,532 at risk EG00111 events10 affected6,535 at risk
Left ventricular dysfunction	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected6,532 at risk EG0014 events4 affected6,535 at risk
Left ventricular failure	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0006 events6 affected6,532 at risk EG0017 events7 affected6,535 at risk
Metabolic cardiomyopathy	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Mitral valve disease	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0012 events1 affected6,535 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0014 events4 affected6,535 at risk
Myocardial fibrosis	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Myocardial infarction	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG00043 events39 affected6,532 at risk EG00151 events51 affected6,535 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG00028 events27 affected6,532 at risk EG00117 events16 affected6,535 at risk
Myocarditis	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Nodal arrhythmia	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Nodal rhythm	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Palpitations	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Paroxysmal atrioventricular block	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Pericardial effusion	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0013 events3 affected6,535 at risk
Pericarditis	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0015 events5 affected6,535 at risk
Pleuropericarditis	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Postinfarction angina	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Pulmonary valve stenosis	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0012 events1 affected6,535 at risk
Pulseless electrical activity	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0015 events4 affected6,535 at risk
Right ventricular failure	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Silent myocardial infarction	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Sinoatrial block	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Sinus arrest	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Sinus bradycardia	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected6,532 at risk EG0010 events0 affected6,535 at risk
Sinus node dysfunction	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0006 events6 affected6,532 at risk EG0015 events5 affected6,535 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0012 events2 affected6,535 at risk
Supraventricular extrasystoles	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0006 events6 affected6,532 at risk EG0015 events5 affected6,535 at risk
Tachyarrhythmia	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0012 events2 affected6,535 at risk
Tachycardia	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0013 events3 affected6,535 at risk
Ventricular arrhythmia	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Ventricular dysfunction	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0005 events5 affected6,532 at risk EG0015 events5 affected6,535 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0008 events7 affected6,532 at risk EG0018 events8 affected6,535 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG00014 events13 affected6,532 at risk EG00116 events14 affected6,535 at risk
Arteriovenous malformation	Congenital, familial and genetic disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Atrial septal defect	Congenital, familial and genetic disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Cerebrovascular arteriovenous malformation	Congenital, familial and genetic disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Familial mediterranean fever	Congenital, familial and genetic disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Gastrointestinal arteriovenous malformation	Congenital, familial and genetic disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Hypertrophic cardiomyopathy	Congenital, familial and genetic disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Phimosis	Congenital, familial and genetic disorders	MedDRA 22.1	Systematic Assessment	EG0004 events4 affected6,532 at risk EG0011 events1 affected6,535 at risk
Porokeratosis	Congenital, familial and genetic disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Pyloric stenosis	Congenital, familial and genetic disorders	MedDRA 22.1	Systematic Assessment	EG0002 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Deafness	Ear and labyrinth disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0012 events2 affected6,535 at risk
Deafness neurosensory	Ear and labyrinth disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0013 events2 affected6,535 at risk
Deafness unilateral	Ear and labyrinth disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Hypoacusis	Ear and labyrinth disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Otolithiasis	Ear and labyrinth disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0012 events2 affected6,535 at risk
Sudden hearing loss	Ear and labyrinth disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0012 events1 affected6,535 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0012 events1 affected6,535 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 22.1	Systematic Assessment	EG00013 events12 affected6,532 at risk EG00111 events11 affected6,535 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0012 events2 affected6,535 at risk
Vestibular disorder	Ear and labyrinth disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0012 events2 affected6,535 at risk
Acromegaly	Endocrine disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Adrenal mass	Endocrine disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Goitre	Endocrine disorders	MedDRA 22.1	Systematic Assessment	EG0004 events4 affected6,532 at risk EG0018 events8 affected6,535 at risk
Hyperparathyroidism primary	Endocrine disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0011 events1 affected6,535 at risk
Hypothyroidism	Endocrine disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0012 events2 affected6,535 at risk
Parathyroid disorder	Endocrine disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Thyroid mass	Endocrine disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Cataract	Eye disorders	MedDRA 22.1	Systematic Assessment	EG00035 events29 affected6,532 at risk EG00124 events20 affected6,535 at risk
Conjunctival erosion	Eye disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Conjunctivochalasis	Eye disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Corneal erosion	Eye disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Dacryostenosis acquired	Eye disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Diabetic retinopathy	Eye disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Diplopia	Eye disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Exophthalmos	Eye disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Eyelid ptosis	Eye disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0012 events2 affected6,535 at risk
Glaucoma	Eye disorders	MedDRA 22.1	Systematic Assessment	EG0005 events4 affected6,532 at risk EG0011 events1 affected6,535 at risk
Iridocyclitis	Eye disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Macular hole	Eye disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0010 events0 affected6,535 at risk
Maculopathy	Eye disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Open angle glaucoma	Eye disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0010 events0 affected6,535 at risk
Optic ischaemic neuropathy	Eye disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Retinal artery embolism	Eye disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0010 events0 affected6,535 at risk
Retinal artery occlusion	Eye disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0011 events1 affected6,535 at risk
Retinal detachment	Eye disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0012 events2 affected6,535 at risk
Retinal haemorrhage	Eye disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Retinal tear	Eye disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0010 events0 affected6,535 at risk
Retinal vein occlusion	Eye disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Retinopathy	Eye disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Rhegmatogenous retinal detachment	Eye disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0013 events1 affected6,535 at risk
Tractional retinal detachment	Eye disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0012 events1 affected6,535 at risk
Vitreous detachment	Eye disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Vitreous disorder	Eye disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Vitreous haemorrhage	Eye disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0011 events1 affected6,535 at risk
Abdominal adhesions	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0012 events2 affected6,535 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0005 events5 affected6,532 at risk EG0015 events5 affected6,535 at risk
Abdominal hernia obstructive	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Abdominal incarcerated hernia	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0009 events8 affected6,532 at risk EG00111 events9 affected6,535 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0010 events0 affected6,535 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected6,532 at risk EG0013 events3 affected6,535 at risk
Abdominal wall haematoma	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Alcoholic pancreatitis	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Anal fistula	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0010 events0 affected6,535 at risk
Anal haemorrhage	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Anal stenosis	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Anogenital dysplasia	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Ascites	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Barrett's oesophagus	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Chronic gastritis	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected6,532 at risk EG0018 events7 affected6,535 at risk
Coeliac artery stenosis	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Colitis	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0007 events7 affected6,532 at risk EG0018 events7 affected6,535 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected6,532 at risk EG0012 events2 affected6,535 at risk
Colitis ulcerative	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0014 events3 affected6,535 at risk
Colonic fistula	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Constipation	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0007 events6 affected6,532 at risk EG0015 events5 affected6,535 at risk
Crohn's disease	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0010 events0 affected6,535 at risk
Dental cyst	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0010 events0 affected6,535 at risk
Diabetic gastroparesis	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Diabetic gastropathy	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Diaphragmatic hernia	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG00021 events21 affected6,532 at risk EG00111 events10 affected6,535 at risk
Dieulafoy's vascular malformation	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Diverticular perforation	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Diverticulum	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected6,532 at risk EG0014 events4 affected6,535 at risk
Diverticulum intestinal	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected6,532 at risk EG0010 events0 affected6,535 at risk
Diverticulum intestinal haemorrhagic	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0013 events3 affected6,535 at risk
Duodenal perforation	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Duodenal polyp	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0005 events5 affected6,532 at risk EG0013 events3 affected6,535 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0004 events4 affected6,532 at risk EG0013 events3 affected6,535 at risk
Duodenal ulcer perforation	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Duodenitis	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0010 events0 affected6,535 at risk
Duodenogastric reflux	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Dysbiosis	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0011 events1 affected6,535 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0011 events1 affected6,535 at risk
Enteritis	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0012 events2 affected6,535 at risk
Enterovesical fistula	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Erosive duodenitis	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Faecaloma	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0012 events2 affected6,535 at risk
Functional gastrointestinal disorder	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Gastric disorder	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Gastric polyps	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected6,532 at risk EG0012 events2 affected6,535 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0005 events5 affected6,532 at risk EG0011 events1 affected6,535 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0004 events4 affected6,532 at risk EG0011 events1 affected6,535 at risk
Gastric ulcer perforation	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Gastritis	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0009 events9 affected6,532 at risk EG0018 events8 affected6,535 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0006 events6 affected6,532 at risk EG0013 events3 affected6,535 at risk
Gastritis haemorrhagic	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Gastroduodenal ulcer	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0010 events0 affected6,535 at risk
Gastrointestinal erosion	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG00031 events24 affected6,532 at risk EG00111 events10 affected6,535 at risk
Gastrointestinal inflammation	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Gastrointestinal pain	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Gastrointestinal polyp haemorrhage	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0012 events2 affected6,535 at risk
Gastrointestinal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Gastrointestinal vascular malformation haemorrhagic	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0007 events7 affected6,532 at risk EG0017 events7 affected6,535 at risk
Gingival bleeding	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0011 events1 affected6,535 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0004 events4 affected6,532 at risk EG0011 events1 affected6,535 at risk
Haemorrhagic erosive gastritis	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0017 events6 affected6,535 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0005 events5 affected6,532 at risk EG0015 events5 affected6,535 at risk
Haemorrhoids thrombosed	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0014 events3 affected6,535 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0004 events4 affected6,532 at risk EG0011 events1 affected6,535 at risk
Ileus	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected6,532 at risk EG0011 events1 affected6,535 at risk
Ileus paralytic	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Incarcerated inguinal hernia	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG00019 events18 affected6,532 at risk EG00112 events11 affected6,535 at risk
Intestinal haemorrhage	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Intestinal ischaemia	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Intestinal mass	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0007 events7 affected6,532 at risk EG0014 events4 affected6,535 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0003 events2 affected6,532 at risk EG0010 events0 affected6,535 at risk
Intestinal polyp	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0013 events3 affected6,535 at risk
Intestinal pseudo-obstruction	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Intra-abdominal haemorrhage	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Irritable bowel syndrome	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0012 events2 affected6,535 at risk
Large intestinal obstruction	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Large intestinal stenosis	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG00015 events14 affected6,532 at risk EG00119 events13 affected6,535 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0012 events2 affected6,535 at risk
Mechanical ileus	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0012 events2 affected6,535 at risk
Melaena	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Mesenteric artery stenosis	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Mesenteric haemorrhage	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Mesenteric vascular insufficiency	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Mouth haemorrhage	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Nausea	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0004 events4 affected6,532 at risk EG0013 events3 affected6,535 at risk
Noninfective sialoadenitis	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0012 events2 affected6,535 at risk
Obstructive pancreatitis	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected6,532 at risk EG0010 events0 affected6,535 at risk
Oedematous pancreatitis	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Oesophageal achalasia	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Oesophageal spasm	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0012 events2 affected6,535 at risk
Oesophageal stenosis	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Oesophageal varices haemorrhage	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0011 events1 affected6,535 at risk
Pancreatic disorder	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG00011 events11 affected6,532 at risk EG00110 events10 affected6,535 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG00016 events12 affected6,532 at risk EG00111 events11 affected6,535 at risk
Pancreatitis chronic	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0013 events3 affected6,535 at risk
Peptic ulcer	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0013 events3 affected6,535 at risk
Peptic ulcer haemorrhage	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Pharyngo-oesophageal diverticulum	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Pneumatosis intestinalis	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0008 events7 affected6,532 at risk EG0015 events5 affected6,535 at risk
Rectal polyp	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0012 events1 affected6,535 at risk
Rectal prolapse	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Reflux gastritis	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Retroperitoneal fibrosis	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0003 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Retroperitoneal haematoma	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Retroperitoneal haemorrhage	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Retroperitoneal mass	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0006 events5 affected6,532 at risk EG00112 events9 affected6,535 at risk
Thrombosis mesenteric vessel	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Tongue cyst	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0005 events5 affected6,532 at risk EG0012 events2 affected6,535 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG00012 events12 affected6,532 at risk EG0013 events3 affected6,535 at risk
Volvulus	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Volvulus of small bowel	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Vomiting	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0009 events8 affected6,532 at risk EG0011 events1 affected6,535 at risk
Adverse drug reaction	General disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Adverse event	General disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Asthenia	General disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0012 events2 affected6,535 at risk
Cardiac death	General disorders	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected6,532 at risk EG0013 events3 affected6,535 at risk
Catheter site haemorrhage	General disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Chest discomfort	General disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0014 events4 affected6,535 at risk
Chest pain	General disorders	MedDRA 22.1	Systematic Assessment	EG00010 events10 affected6,532 at risk EG00123 events23 affected6,535 at risk
Complication associated with device	General disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Cyst	General disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Death	General disorders	MedDRA 22.1	Systematic Assessment	EG00057 events57 affected6,532 at risk EG00138 events38 affected6,535 at risk
Decreased activity	General disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Device related thrombosis	General disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Drowning	General disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Drug intolerance	General disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Exercise tolerance decreased	General disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0010 events0 affected6,535 at risk
Fatigue	General disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Gait disturbance	General disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
General physical health deterioration	General disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0010 events0 affected6,535 at risk
Generalised oedema	General disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Hernia	General disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Impaired healing	General disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0012 events2 affected6,535 at risk
Implant site haematoma	General disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Implant site inflammation	General disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Inflammation	General disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Injection site phlebitis	General disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Malaise	General disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0012 events2 affected6,535 at risk
Medical device site haematoma	General disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Mucosal inflammation	General disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Multi-organ disorder	General disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA 22.1	Systematic Assessment	EG0005 events5 affected6,532 at risk EG0012 events2 affected6,535 at risk
No adverse event	General disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Nodule	General disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Non-cardiac chest pain	General disorders	MedDRA 22.1	Systematic Assessment	EG00069 events51 affected6,532 at risk EG00153 events51 affected6,535 at risk
Oedema peripheral	General disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0014 events3 affected6,535 at risk
Organ failure	General disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Pelvic mass	General disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Perforation	General disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Peripheral swelling	General disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0013 events3 affected6,535 at risk
Pyrexia	General disorders	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected6,532 at risk EG0014 events4 affected6,535 at risk
Retention cyst	General disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Stent-graft endoleak	General disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Sudden cardiac death	General disorders	MedDRA 22.1	Systematic Assessment	EG0005 events5 affected6,532 at risk EG0014 events4 affected6,535 at risk
Sudden death	General disorders	MedDRA 22.1	Systematic Assessment	EG0004 events4 affected6,532 at risk EG0013 events3 affected6,535 at risk
Surgical failure	General disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Ulcer haemorrhage	General disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Unevaluable event	General disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Vascular stent occlusion	General disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Vascular stent stenosis	General disorders	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected6,532 at risk EG0012 events2 affected6,535 at risk
Vascular stent thrombosis	General disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0015 events5 affected6,535 at risk
Bile duct stenosis	Hepatobiliary disorders	MedDRA 22.1	Systematic Assessment	EG0002 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA 22.1	Systematic Assessment	EG0006 events4 affected6,532 at risk EG0013 events3 affected6,535 at risk
Biliary colic	Hepatobiliary disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Biliary tract disorder	Hepatobiliary disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Cholangitis	Hepatobiliary disorders	MedDRA 22.1	Systematic Assessment	EG0006 events6 affected6,532 at risk EG0015 events5 affected6,535 at risk
Cholangitis acute	Hepatobiliary disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0012 events2 affected6,535 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 22.1	Systematic Assessment	EG00013 events13 affected6,532 at risk EG00118 events17 affected6,535 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 22.1	Systematic Assessment	EG00020 events20 affected6,532 at risk EG00113 events12 affected6,535 at risk
Cholecystitis chronic	Hepatobiliary disorders	MedDRA 22.1	Systematic Assessment	EG0004 events4 affected6,532 at risk EG0015 events4 affected6,535 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 22.1	Systematic Assessment	EG00028 events27 affected6,532 at risk EG00116 events15 affected6,535 at risk
Chronic hepatitis	Hepatobiliary disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected6,532 at risk EG0012 events2 affected6,535 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0012 events2 affected6,535 at risk
Hepatic steatosis	Hepatobiliary disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0012 events2 affected6,535 at risk
Hepatitis	Hepatobiliary disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Ischaemic hepatitis	Hepatobiliary disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Jaundice	Hepatobiliary disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Jaundice cholestatic	Hepatobiliary disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Liver disorder	Hepatobiliary disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Non-alcoholic steatohepatitis	Hepatobiliary disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0011 events1 affected6,535 at risk
Nonalcoholic fatty liver disease	Hepatobiliary disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0011 events1 affected6,535 at risk
Portal vein thrombosis	Hepatobiliary disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Post cholecystectomy syndrome	Hepatobiliary disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Anaphylactic reaction	Immune system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0013 events3 affected6,535 at risk
Anaphylactic shock	Immune system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Contrast media allergy	Immune system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0011 events1 affected6,535 at risk
Heart transplant rejection	Immune system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0012 events1 affected6,535 at risk
Hypersensitivity	Immune system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Kidney transplant rejection	Immune system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Sarcoidosis	Immune system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Abdominal abscess	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0011 events1 affected6,535 at risk
Abdominal wall abscess	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0013 events2 affected6,535 at risk
Abdominal wall infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Abscess	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Abscess limb	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0004 events4 affected6,532 at risk EG0016 events6 affected6,535 at risk
Acarodermatitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Acquired immunodeficiency syndrome	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Acute hepatitis b	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Acute sinusitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0014 events3 affected6,535 at risk
Adenovirus infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Anal abscess	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0013 events3 affected6,535 at risk
Appendicitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0009 events9 affected6,532 at risk EG00114 events14 affected6,535 at risk
Appendicitis perforated	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0005 events5 affected6,532 at risk EG0011 events1 affected6,535 at risk
Arthritis bacterial	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0014 events4 affected6,535 at risk
Arthritis infective	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0011 events1 affected6,535 at risk
Atypical pneumonia	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Bacteraemia	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0004 events4 affected6,532 at risk EG0014 events4 affected6,535 at risk
Bacterial colitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Bacterial infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Bacterial prostatitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Beta haemolytic streptococcal infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Biliary sepsis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0012 events2 affected6,535 at risk
Borrelia infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Breast abscess	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0011 events1 affected6,535 at risk
Bronchitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG00011 events10 affected6,532 at risk EG00123 events23 affected6,535 at risk
Bronchitis viral	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0013 events3 affected6,535 at risk
Bursitis infective	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Campylobacter colitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Campylobacter gastroenteritis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0010 events0 affected6,535 at risk
Candida pneumonia	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Carbuncle	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Cellulitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG00046 events39 affected6,532 at risk EG00152 events46 affected6,535 at risk
Cellulitis of male external genital organ	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0010 events0 affected6,535 at risk
Cellulitis staphylococcal	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Chest wall abscess	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Cholangitis infective	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Cholecystitis infective	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0014 events3 affected6,535 at risk
Chronic sinusitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0011 events1 affected6,535 at risk
Clostridium difficile infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Cystitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0005 events4 affected6,532 at risk EG0011 events1 affected6,535 at risk
Dermatitis infected	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Device related infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0004 events2 affected6,532 at risk EG0012 events2 affected6,535 at risk
Diabetic foot infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0014 events3 affected6,535 at risk
Diabetic gangrene	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Diarrhoea infectious	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Diverticulitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG00016 events13 affected6,532 at risk EG00112 events9 affected6,535 at risk
Diverticulitis intestinal haemorrhagic	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Dysentery	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Emphysematous pyelonephritis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Empyema	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Endocarditis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0012 events2 affected6,535 at risk
Endocarditis bacterial	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Enterococcal sepsis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Epidemic pleurodynia	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Epididymitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0002 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Erysipelas	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG00010 events6 affected6,532 at risk EG0017 events6 affected6,535 at risk
Escherichia bacteraemia	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Escherichia infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Escherichia pyelonephritis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Escherichia sepsis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0010 events0 affected6,535 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0012 events2 affected6,535 at risk
External ear cellulitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Extradural abscess	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Folliculitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Fournier's gangrene	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Fungal infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Gallbladder abscess	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Gallbladder empyema	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Gangrene	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0007 events7 affected6,532 at risk EG00111 events9 affected6,535 at risk
Gastroenteritis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG00016 events15 affected6,532 at risk EG00120 events20 affected6,535 at risk
Gastroenteritis clostridial	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0005 events4 affected6,532 at risk EG0014 events4 affected6,535 at risk
Gastrointestinal infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Gastrointestinal viral infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Genitourinary tract infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Graft infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Groin abscess	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected6,532 at risk EG0010 events0 affected6,535 at risk
Hiv infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Haematoma infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Helicobacter gastritis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Hepatic cyst infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Hepatitis c	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0013 events3 affected6,535 at risk
Herpes zoster	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0004 events4 affected6,532 at risk EG0014 events4 affected6,535 at risk
Implant site infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0012 events2 affected6,535 at risk
Incision site cellulitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Infected cyst	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Infected dermal cyst	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Infected skin ulcer	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Infectious pleural effusion	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Infective aneurysm	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0013 events3 affected6,535 at risk
Infective tenosynovitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Influenza	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG00013 events12 affected6,532 at risk EG00115 events15 affected6,535 at risk
Intervertebral discitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Intestinal gangrene	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Kidney infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Klebsiella infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Large intestine infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Laryngitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Liver abscess	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0006 events3 affected6,532 at risk EG0012 events2 affected6,535 at risk
Localised infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0019 events5 affected6,535 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0008 events8 affected6,532 at risk EG00113 events12 affected6,535 at risk
Lower respiratory tract infection bacterial	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Lyme disease	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0010 events0 affected6,535 at risk
Lymphangitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Mastitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Mediastinitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0010 events0 affected6,535 at risk
Medical device site abscess	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Medical device site infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Medical device site joint infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Meningitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Meningitis bacterial	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0013 events2 affected6,535 at risk
Meningoencephalitis herpetic	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Moraxella infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Mycetoma mycotic	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Nasopharyngitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Necrotising fasciitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0010 events0 affected6,535 at risk
Oesophageal candidiasis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0011 events1 affected6,535 at risk
Orchitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Osteomyelitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG00011 events9 affected6,532 at risk EG00116 events12 affected6,535 at risk
Osteomyelitis acute	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Osteomyelitis chronic	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Otitis externa	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Otitis media	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Otitis media acute	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0010 events0 affected6,535 at risk
Otitis media bacterial	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Otitis media chronic	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Parainfluenzae virus infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Parotitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0012 events2 affected6,535 at risk
Pelvic infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Perineal abscess	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Periodontitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Perirectal abscess	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0010 events0 affected6,535 at risk
Peritonitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0013 events3 affected6,535 at risk
Peritonsillitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Pilonidal cyst	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Pneumonia	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG000130 events113 affected6,532 at risk EG001135 events126 affected6,535 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0012 events2 affected6,535 at risk
Pneumonia haemophilus	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Pneumonia legionella	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Pneumonia pseudomonal	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Pneumonia staphylococcal	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Pneumonia streptococcal	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0010 events0 affected6,535 at risk
Pneumonia viral	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0010 events0 affected6,535 at risk
Post procedural cellulitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Post procedural sepsis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0004 events4 affected6,532 at risk EG0011 events1 affected6,535 at risk
Postoperative abscess	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0010 events0 affected6,535 at risk
Postoperative wound infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0008 events8 affected6,532 at risk EG0012 events2 affected6,535 at risk
Pseudomonas infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Psoas abscess	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Pulmonary nocardiosis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Pulmonary sepsis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Pyelonephritis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0009 events9 affected6,532 at risk EG00112 events12 affected6,535 at risk
Pyelonephritis acute	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0009 events7 affected6,532 at risk EG0013 events3 affected6,535 at risk
Pyelonephritis chronic	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0005 events5 affected6,532 at risk EG0011 events1 affected6,535 at risk
Rectal abscess	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Renal abscess	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Renal cyst infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Respiratory tract infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0012 events2 affected6,535 at risk
Respiratory tract infection viral	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Rotavirus infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Salmonellosis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Scrotal abscess	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0012 events2 affected6,535 at risk
Sepsis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG00051 events49 affected6,532 at risk EG00147 events43 affected6,535 at risk
Septic necrosis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Septic shock	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0008 events8 affected6,532 at risk EG00110 events7 affected6,535 at risk
Sinobronchitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Sinusitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0012 events2 affected6,535 at risk
Skin infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Staphylococcal abscess	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0012 events2 affected6,535 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0013 events3 affected6,535 at risk
Staphylococcal infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0013 events3 affected6,535 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0014 events4 affected6,535 at risk
Streptococcal abscess	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Streptococcal sepsis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0010 events0 affected6,535 at risk
Subcutaneous abscess	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0012 events2 affected6,535 at risk
Tonsillitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Tooth abscess	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Tracheitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Tracheobronchitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0013 events3 affected6,535 at risk
Urinary tract infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG00026 events24 affected6,532 at risk EG00140 events36 affected6,535 at risk
Urosepsis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0009 events9 affected6,532 at risk EG0019 events9 affected6,535 at risk
Vestibular neuronitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0004 events3 affected6,532 at risk EG0012 events2 affected6,535 at risk
Viral infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0012 events2 affected6,535 at risk
Wound infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0017 events7 affected6,535 at risk
Wound infection bacterial	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Wound sepsis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0011 events1 affected6,535 at risk
Abdominal injury	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Accidental overdose	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected6,532 at risk EG0011 events1 affected6,535 at risk
Acetabulum fracture	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Airway complication of anaesthesia	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Alcohol poisoning	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Animal bite	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0005 events5 affected6,532 at risk EG00110 events9 affected6,535 at risk
Arterial bypass occlusion	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Arterial bypass stenosis	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Back injury	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Bone contusion	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Brain contusion	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Burns second degree	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Carbon monoxide poisoning	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Carotid artery restenosis	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0011 events1 affected6,535 at risk
Chest injury	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0015 events5 affected6,535 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0013 events3 affected6,535 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0012 events2 affected6,535 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0003 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Coronary artery restenosis	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected6,532 at risk EG0012 events2 affected6,535 at risk
Cystitis radiation	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Epicondylitis	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Eyelid injury	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG00019 events15 affected6,532 at risk EG00110 events10 affected6,535 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0009 events9 affected6,532 at risk EG0017 events7 affected6,535 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0008 events8 affected6,532 at risk EG0019 events9 affected6,535 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0013 events3 affected6,535 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected6,532 at risk EG0011 events1 affected6,535 at risk
Forearm fracture	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0010 events0 affected6,535 at risk
Foreign body aspiration	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Foreign body in gastrointestinal tract	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0012 events2 affected6,535 at risk
Fracture displacement	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Frostbite	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0005 events5 affected6,532 at risk EG0018 events8 affected6,535 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0004 events4 affected6,532 at risk EG00111 events11 affected6,535 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0005 events5 affected6,532 at risk EG0016 events6 affected6,535 at risk
Hyphaema	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0005 events5 affected6,532 at risk EG0015 events4 affected6,535 at risk
Inflammation of wound	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Injury	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0012 events2 affected6,535 at risk
Intentional overdose	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0014 events4 affected6,535 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0002 events1 affected6,532 at risk EG0013 events3 affected6,535 at risk
Ligament rupture	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0011 events1 affected6,535 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0012 events2 affected6,535 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0014 events3 affected6,535 at risk
Limb traumatic amputation	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0004 events3 affected6,532 at risk EG0013 events3 affected6,535 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0012 events2 affected6,535 at risk
Mallet finger	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Meniscus injury	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0004 events4 affected6,532 at risk EG0013 events3 affected6,535 at risk
Multiple fractures	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0013 events3 affected6,535 at risk
Multiple injuries	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected6,532 at risk EG0011 events1 affected6,535 at risk
Muscle injury	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Muscle rupture	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0011 events1 affected6,535 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Neck injury	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0012 events2 affected6,535 at risk
Patella fracture	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected6,532 at risk EG0010 events0 affected6,535 at risk
Pelvic organ injury	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Peripheral artery restenosis	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Peripheral nerve injury	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Periprosthetic fracture	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Pharyngeal contusion	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Poisoning	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Post concussion syndrome	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Post laminectomy syndrome	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Post procedural complication	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0013 events2 affected6,535 at risk
Post procedural fever	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0011 events1 affected6,535 at risk
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0014 events4 affected6,535 at risk
Post procedural haematuria	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0008 events7 affected6,532 at risk EG0017 events7 affected6,535 at risk
Post procedural swelling	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Postoperative delirium	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Postoperative hypotension	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Postoperative ileus	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0015 events2 affected6,535 at risk
Postoperative respiratory failure	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Postoperative thoracic procedure complication	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Procedural hypotension	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Procedural nausea	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0017 events7 affected6,535 at risk
Pseudomeningocele	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Pubis fracture	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Pulmonary contusion	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Radiation dysphagia	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Radiation injury	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0016 events6 affected6,535 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0007 events7 affected6,532 at risk EG0015 events5 affected6,535 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0006 events6 affected6,532 at risk EG0015 events5 affected6,535 at risk
Scapula fracture	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Shunt thrombosis	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Skeletal injury	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0012 events2 affected6,535 at risk
Skin abrasion	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0012 events2 affected6,535 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0016 events6 affected6,535 at risk
Skull fracture	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Skull fractured base	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Soft tissue injury	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0012 events2 affected6,535 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG00010 events9 affected6,532 at risk EG0015 events5 affected6,535 at risk
Spinal cord injury	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0012 events2 affected6,535 at risk
Splenic injury	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Splenic rupture	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Stress fracture	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Subcutaneous haematoma	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG00014 events11 affected6,532 at risk EG00110 events9 affected6,535 at risk
Subdural haemorrhage	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Suture related complication	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Tendon injury	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0006 events6 affected6,532 at risk EG0015 events5 affected6,535 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0011 events1 affected6,535 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected6,532 at risk EG0010 events0 affected6,535 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0013 events3 affected6,535 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0015 events5 affected6,535 at risk
Traumatic arthrosis	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Traumatic haematoma	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Traumatic haemothorax	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Traumatic ulcer	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Ulna fracture	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0010 events0 affected6,535 at risk
Urethral injury	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Vascular graft occlusion	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Vascular procedure complication	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0012 events2 affected6,535 at risk
Wound	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0010 events0 affected6,535 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0013 events3 affected6,535 at risk
Activated partial thromboplastin time prolonged	Investigations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Alanine aminotransferase increased	Investigations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Anticoagulation drug level above therapeutic	Investigations	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0010 events0 affected6,535 at risk
Anticoagulation drug level increased	Investigations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Blood calcium decreased	Investigations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Blood creatinine increased	Investigations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Blood glucose abnormal	Investigations	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected6,532 at risk EG0010 events0 affected6,535 at risk
Blood glucose decreased	Investigations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Blood glucose fluctuation	Investigations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0012 events1 affected6,535 at risk
Blood glucose increased	Investigations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0012 events2 affected6,535 at risk
Blood lactic acid increased	Investigations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Blood pressure increased	Investigations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0013 events3 affected6,535 at risk
C-reactive protein increased	Investigations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Ejection fraction decreased	Investigations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Electrocardiogram change	Investigations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Glycosylated haemoglobin increased	Investigations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Haemoglobin decreased	Investigations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Heart rate irregular	Investigations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Hepatic enzyme increased	Investigations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
International normalised ratio increased	Investigations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Intraocular pressure increased	Investigations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Liver function test abnormal	Investigations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Liver function test increased	Investigations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Platelet count decreased	Investigations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Prostatic specific antigen increased	Investigations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Sinus rhythm	Investigations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Transaminases increased	Investigations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Transplant evaluation	Investigations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Trial of void	Investigations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Troponin i increased	Investigations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0012 events2 affected6,535 at risk
Troponin increased	Investigations	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0010 events0 affected6,535 at risk
Weight decreased	Investigations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Weight increased	Investigations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Cardiometabolic syndrome	Metabolism and nutrition disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Central obesity	Metabolism and nutrition disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 22.1	Systematic Assessment	EG0009 events8 affected6,532 at risk EG00113 events12 affected6,535 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 22.1	Systematic Assessment	EG00047 events43 affected6,532 at risk EG00150 events49 affected6,535 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 22.1	Systematic Assessment	EG00029 events26 affected6,532 at risk EG00132 events24 affected6,535 at risk
Diabetic complication	Metabolism and nutrition disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 22.1	Systematic Assessment	EG0006 events6 affected6,532 at risk EG0016 events6 affected6,535 at risk
Diabetic ketosis	Metabolism and nutrition disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Diabetic metabolic decompensation	Metabolism and nutrition disorders	MedDRA 22.1	Systematic Assessment	EG00016 events16 affected6,532 at risk EG00114 events13 affected6,535 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0011 events1 affected6,535 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected6,532 at risk EG0013 events3 affected6,535 at risk
Gout	Metabolism and nutrition disorders	MedDRA 22.1	Systematic Assessment	EG0006 events6 affected6,532 at risk EG0019 events7 affected6,535 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0012 events2 affected6,535 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 22.1	Systematic Assessment	EG00013 events13 affected6,532 at risk EG00114 events12 affected6,535 at risk
Hyperglycaemic hyperosmolar nonketotic syndrome	Metabolism and nutrition disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Hyperhomocysteinaemia	Metabolism and nutrition disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 22.1	Systematic Assessment	EG0005 events5 affected6,532 at risk EG00113 events13 affected6,535 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0012 events2 affected6,535 at risk
Hypervolaemia	Metabolism and nutrition disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0013 events2 affected6,535 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 22.1	Systematic Assessment	EG00015 events14 affected6,532 at risk EG00118 events16 affected6,535 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0014 events3 affected6,535 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0013 events3 affected6,535 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 22.1	Systematic Assessment	EG0004 events4 affected6,532 at risk EG0011 events1 affected6,535 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA 22.1	Systematic Assessment	EG0004 events4 affected6,532 at risk EG0011 events1 affected6,535 at risk
Ketoacidosis	Metabolism and nutrition disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Lactic acidosis	Metabolism and nutrition disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0011 events1 affected6,535 at risk
Obesity	Metabolism and nutrition disorders	MedDRA 22.1	Systematic Assessment	EG0006 events6 affected6,532 at risk EG00110 events10 affected6,535 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 22.1	Systematic Assessment	EG00032 events28 affected6,532 at risk EG00119 events18 affected6,535 at risk
Vitamin b12 deficiency	Metabolism and nutrition disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG00011 events10 affected6,532 at risk EG00114 events12 affected6,535 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0008 events8 affected6,532 at risk EG0016 events6 affected6,535 at risk
Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG00010 events8 affected6,532 at risk EG00111 events11 affected6,535 at risk
Bone lesion	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0011 events1 affected6,535 at risk
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0006 events6 affected6,532 at risk EG0014 events4 affected6,535 at risk
Chondrocalcinosis pyrophosphate	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0011 events1 affected6,535 at risk
Compartment syndrome	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0012 events2 affected6,535 at risk
Crystal arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Fibromyalgia	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0012 events2 affected6,535 at risk
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0005 events4 affected6,532 at risk EG0010 events0 affected6,535 at risk
Fracture nonunion	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Gouty arthritis	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Haematoma muscle	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Inguinal mass	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0004 events4 affected6,532 at risk EG0011 events1 affected6,535 at risk
Intervertebral disc disorder	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0012 events2 affected6,535 at risk
Intervertebral disc displacement	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG00013 events13 affected6,532 at risk EG00117 events17 affected6,535 at risk
Joint ankylosis	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Joint effusion	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Limb deformity	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Limb discomfort	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Limb mass	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG00018 events18 affected6,532 at risk EG00111 events11 affected6,535 at risk
Mandibular mass	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Meniscal degeneration	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Mobility decreased	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0012 events2 affected6,535 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0004 events4 affected6,532 at risk EG0011 events1 affected6,535 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0007 events7 affected6,532 at risk EG0019 events9 affected6,535 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected6,532 at risk EG0016 events6 affected6,535 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Myopathy	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Neuropathic arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0010 events0 affected6,535 at risk
Osteitis	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG00069 events66 affected6,532 at risk EG00167 events58 affected6,535 at risk
Osteochondrosis	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected6,532 at risk EG0012 events2 affected6,535 at risk
Osteonecrosis of jaw	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0011 events1 affected6,535 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0006 events6 affected6,532 at risk EG0014 events4 affected6,535 at risk
Periarthritis	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0003 events1 affected6,532 at risk EG0012 events2 affected6,535 at risk
Polymyalgia rheumatica	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0012 events2 affected6,535 at risk
Psoriatic arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Rheumatic disorder	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0014 events4 affected6,535 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0006 events6 affected6,532 at risk EG00110 events10 affected6,535 at risk
Spinal instability	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG00017 events17 affected6,532 at risk EG0018 events8 affected6,535 at risk
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0004 events4 affected6,532 at risk EG0011 events1 affected6,535 at risk
Spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0004 events4 affected6,532 at risk EG00111 events11 affected6,535 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0004 events4 affected6,532 at risk EG0013 events3 affected6,535 at risk
Spondylolysis	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Tendon disorder	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0012 events2 affected6,535 at risk
Tenosynovitis	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Thoracic spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Vertebral foraminal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0010 events0 affected6,535 at risk
Acoustic neuroma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Acute lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0002 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0012 events2 affected6,535 at risk
Acute promyelocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Adenocarcinoma gastric	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0005 events3 affected6,532 at risk EG0011 events1 affected6,535 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0005 events4 affected6,532 at risk EG0016 events6 affected6,535 at risk
Adenocarcinoma pancreas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0004 events4 affected6,532 at risk EG0010 events0 affected6,535 at risk
Adrenal adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0011 events1 affected6,535 at risk
Anal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Angiomyolipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Anogenital warts	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
B-cell prolymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
B-cell small lymphocytic lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG00015 events15 affected6,532 at risk EG00122 events17 affected6,535 at risk
Benign bone neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Benign neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Benign neoplasm of adrenal gland	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Benign neoplasm of bladder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Benign neoplasm of eyelid	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Benign neoplasm of thyroid gland	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Benign ovarian tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Benign pancreatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Bile duct cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0009 events9 affected6,532 at risk EG00110 events9 affected6,535 at risk
Bladder cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0012 events2 affected6,535 at risk
Bladder cancer stage i, with cancer in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Bladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected6,532 at risk EG0017 events6 affected6,535 at risk
Bladder squamous cell carcinoma stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected6,532 at risk EG0015 events5 affected6,535 at risk
Bladder transitional cell carcinoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Bone cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Bowen's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0013 events3 affected6,535 at risk
Brain cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Brain neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0010 events0 affected6,535 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0009 events8 affected6,532 at risk EG00117 events17 affected6,535 at risk
Breast cancer female	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected6,532 at risk EG0013 events3 affected6,535 at risk
Breast cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Breast cancer stage i	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Breast cancer stage ii	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Breast neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0014 events3 affected6,535 at risk
Bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0011 events1 affected6,535 at risk
Bronchioloalveolar carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Carcinoid tumour pulmonary	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0012 events2 affected6,535 at risk
Cardiac neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Castleman's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Cervix carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Cholangiocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0011 events1 affected6,535 at risk
Chronic lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Chronic myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Clear cell renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected6,532 at risk EG0012 events2 affected6,535 at risk
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0004 events3 affected6,532 at risk EG0014 events4 affected6,535 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG00011 events10 affected6,532 at risk EG00121 events20 affected6,535 at risk
Colon cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0011 events1 affected6,535 at risk
Colon cancer stage 0	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Colon cancer stage iv	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Colon neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0005 events5 affected6,532 at risk EG0010 events0 affected6,535 at risk
Colorectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Colorectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0012 events2 affected6,535 at risk
Colorectal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0012 events1 affected6,535 at risk
Craniopharyngioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Diffuse large b-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Ear neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Endometrial adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Endometrial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0012 events2 affected6,535 at risk
Essential thrombocythaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Female reproductive neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Gallbladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Gastric adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected6,532 at risk EG0014 events4 affected6,535 at risk
Gastrointestinal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0011 events1 affected6,535 at risk
Gastrointestinal stromal tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Glioblastoma multiforme	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Haemangioma of bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Head and neck cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Hepatic cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected6,532 at risk EG0015 events5 affected6,535 at risk
Hepatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Hepatocellular carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0004 events4 affected6,532 at risk EG0013 events3 affected6,535 at risk
Immune reconstitution inflammatory syndrome associated kaposi's sarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Intestinal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Intraductal papillary mucinous neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Intraductal papilloma of breast	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Intraductal proliferative breast lesion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Invasive breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0004 events4 affected6,532 at risk EG0015 events5 affected6,535 at risk
Keratinising squamous cell carcinoma of nasopharynx	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Large intestine benign neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Laryngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0014 events3 affected6,535 at risk
Laryngeal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Laryngeal squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Lentigo maligna	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0012 events2 affected6,535 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0009 events7 affected6,532 at risk EG00111 events9 affected6,535 at risk
Lung adenocarcinoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0004 events3 affected6,532 at risk EG0012 events2 affected6,535 at risk
Lung carcinoma cell type unspecified stage ii	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Lung carcinoma cell type unspecified stage iv	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected6,532 at risk EG0010 events0 affected6,535 at risk
Lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected6,532 at risk EG0013 events3 affected6,535 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0008 events8 affected6,532 at risk EG00112 events12 affected6,535 at risk
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0004 events4 affected6,532 at risk EG0011 events1 affected6,535 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG00012 events11 affected6,532 at risk EG0017 events7 affected6,535 at risk
Malignant melanoma stage iv	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Malignant neoplasm of eye	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Malignant neoplasm of renal pelvis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Malignant neoplasm of spinal cord	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Malignant pleural effusion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Malignant polyp	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Mantle cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0003 events2 affected6,532 at risk EG0012 events2 affected6,535 at risk
Meningioma benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0012 events2 affected6,535 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0011 events1 affected6,535 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected6,532 at risk EG0011 events1 affected6,535 at risk
Metastases to lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0004 events4 affected6,532 at risk EG0010 events0 affected6,535 at risk
Metastases to lymph nodes	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0010 events0 affected6,535 at risk
Metastases to peritoneum	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0011 events1 affected6,535 at risk
Metastases to pleura	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Metastases to rectum	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Metastases to soft tissue	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Metastasis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Metastatic gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Metastatic malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected6,532 at risk EG0010 events0 affected6,535 at risk
Metastatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0012 events2 affected6,535 at risk
Metastatic squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0011 events1 affected6,535 at risk
Metastatic uterine cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Mucoepidermoid carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0011 events1 affected6,535 at risk
Myelofibrosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0004 events4 affected6,532 at risk EG0014 events4 affected6,535 at risk
Neoplasm of appendix	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Neoplasm prostate	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Neoplasm skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Neuroendocrine carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0010 events0 affected6,535 at risk
Neuroendocrine carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0010 events0 affected6,535 at risk
Neuroendocrine carcinoma of the skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0010 events0 affected6,535 at risk
Neuroendocrine tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected6,532 at risk EG0010 events0 affected6,535 at risk
Nodular melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Non-hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0013 events3 affected6,535 at risk
Non-hodgkin's lymphoma stage i	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0014 events4 affected6,535 at risk
Non-small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Non-small cell lung cancer stage iiia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Non-small cell lung cancer stage iv	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Oesophageal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected6,532 at risk EG0011 events1 affected6,535 at risk
Oesophageal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Oesophageal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0006 events6 affected6,532 at risk EG0012 events2 affected6,535 at risk
Oesophageal papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Oesophageal squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0013 events3 affected6,535 at risk
Oral neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Oropharyngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Oropharyngeal squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Ovarian adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0012 events2 affected6,535 at risk
Ovarian cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Ovarian endometrioid carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Ovarian granulosa cell tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Paget's disease of the vulva	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG00012 events12 affected6,532 at risk EG0016 events4 affected6,535 at risk
Pancreatic carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0004 events4 affected6,532 at risk EG0012 events2 affected6,535 at risk
Pancreatic carcinoma stage iv	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Papillary renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0012 events2 affected6,535 at risk
Papillary thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0012 events2 affected6,535 at risk
Parathyroid tumour benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0013 events3 affected6,535 at risk
Pituitary tumour benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0016 events4 affected6,535 at risk
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0015 events4 affected6,535 at risk
Plasmacytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG00034 events34 affected6,532 at risk EG00134 events33 affected6,535 at risk
Prostate cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0014 events3 affected6,535 at risk
Prostate cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Prostate cancer stage iv	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Prostatic adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Queyrat erythroplasia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Rectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0014 events4 affected6,535 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0014 events4 affected6,535 at risk
Rectal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Rectal cancer stage iv	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Rectal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Rectosigmoid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0011 events1 affected6,535 at risk
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0011 events1 affected6,535 at risk
Renal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Renal cancer stage i	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0007 events6 affected6,532 at risk EG0010 events0 affected6,535 at risk
Renal cell carcinoma stage iv	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Retroperitoneal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Salivary gland adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Salivary gland neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Schwannoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Secretory adenoma of pituitary	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Sinonasal papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Skin cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected6,532 at risk EG0012 events2 affected6,535 at risk
Small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0011 events1 affected6,535 at risk
Small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Small intestine carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Soft tissue neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Spindle cell sarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0004 events3 affected6,532 at risk EG0015 events4 affected6,535 at risk
Squamous cell carcinoma of lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0006 events6 affected6,532 at risk EG0015 events5 affected6,535 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0004 events4 affected6,532 at risk EG00110 events8 affected6,535 at risk
Squamous cell carcinoma of the oral cavity	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0010 events0 affected6,535 at risk
Squamous cell carcinoma of the tongue	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0013 events3 affected6,535 at risk
Superficial spreading melanoma stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
T-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Thyroid adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0013 events3 affected6,535 at risk
Thyroid cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Tongue neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0012 events2 affected6,535 at risk
Tongue neoplasm malignant stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0012 events2 affected6,535 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0004 events4 affected6,532 at risk EG0014 events4 affected6,535 at risk
Ureteric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Urinary tract neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Uterine cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0004 events4 affected6,532 at risk EG0010 events0 affected6,535 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0015 events5 affected6,535 at risk
Vaginal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Altered state of consciousness	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0011 events1 affected6,535 at risk
Amnesia	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Amyotrophic lateral sclerosis	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0002 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Aphasia	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0012 events2 affected6,535 at risk
Autonomic nervous system imbalance	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Balance disorder	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Basal ganglia infarction	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Basilar artery aneurysm	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Basilar artery stenosis	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Brain stem ischaemia	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Brain stem stroke	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Carotid arteriosclerosis	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0012 events2 affected6,535 at risk
Carotid artery disease	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0010 events0 affected6,535 at risk
Carotid artery occlusion	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0012 events2 affected6,535 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG00018 events17 affected6,532 at risk EG00115 events14 affected6,535 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected6,532 at risk EG0014 events4 affected6,535 at risk
Cerebellar infarction	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0012 events2 affected6,535 at risk
Cerebellar stroke	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Cerebral artery stenosis	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Cerebral haematoma	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0012 events2 affected6,535 at risk
Cerebral infarction	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG00012 events12 affected6,532 at risk EG00118 events17 affected6,535 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0006 events6 affected6,532 at risk EG00115 events12 affected6,535 at risk
Cerebral small vessel ischaemic disease	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Cerebral venous sinus thrombosis	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG00046 events45 affected6,532 at risk EG00143 events42 affected6,535 at risk
Cerebrovascular insufficiency	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0004 events4 affected6,532 at risk EG0014 events4 affected6,535 at risk
Cerebrovascular stenosis	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Cervical radiculopathy	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0012 events2 affected6,535 at risk
Cervicobrachial syndrome	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Cluster headache	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Cognitive disorder	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Dementia	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0004 events4 affected6,532 at risk EG0014 events3 affected6,535 at risk
Dementia alzheimer's type	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Demyelination	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Diabetic autonomic neuropathy	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Diabetic coma	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Diabetic neuropathy	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0007 events6 affected6,532 at risk EG0016 events6 affected6,535 at risk
Dizziness	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0006 events6 affected6,532 at risk EG0016 events6 affected6,535 at risk
Dizziness postural	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Embolic stroke	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Encephalopathy	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected6,532 at risk EG0014 events4 affected6,535 at risk
Epilepsy	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0004 events4 affected6,532 at risk EG0013 events3 affected6,535 at risk
Essential tremor	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Facial paralysis	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG00010 events10 affected6,532 at risk EG0016 events6 affected6,535 at risk
Facial paresis	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Generalised tonic-clonic seizure	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0012 events2 affected6,535 at risk
Haemorrhagic stroke	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0004 events4 affected6,532 at risk EG0014 events4 affected6,535 at risk
Haemorrhagic transformation stroke	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Headache	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0011 events1 affected6,535 at risk
Hemiparesis	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0014 events3 affected6,535 at risk
Hepatic encephalopathy	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0002 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Hypertensive encephalopathy	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected6,532 at risk EG0013 events3 affected6,535 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0011 events1 affected6,535 at risk
Hypotonia	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Iiird nerve paralysis	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Intracranial aneurysm	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0012 events2 affected6,535 at risk
Intracranial mass	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Ischaemic cerebral infarction	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0012 events2 affected6,535 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG00033 events30 affected6,532 at risk EG00124 events24 affected6,535 at risk
Lacunar infarction	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected6,532 at risk EG0018 events7 affected6,535 at risk
Lacunar stroke	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Loss of consciousness	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected6,532 at risk EG0014 events4 affected6,535 at risk
Lumbar radiculopathy	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected6,532 at risk EG0012 events2 affected6,535 at risk
Lumbosacral plexus lesion	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Lumbosacral radiculopathy	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0012 events2 affected6,535 at risk
Memory impairment	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Mental impairment	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Metabolic encephalopathy	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0004 events4 affected6,532 at risk EG0011 events1 affected6,535 at risk
Migraine	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0003 events2 affected6,532 at risk EG0011 events1 affected6,535 at risk
Monoplegia	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Motor neurone disease	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0010 events0 affected6,535 at risk
Multiple sclerosis	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0010 events0 affected6,535 at risk
Multiple sclerosis relapse	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0004 events2 affected6,532 at risk EG0010 events0 affected6,535 at risk
Myasthenia gravis	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0006 events2 affected6,532 at risk EG0010 events0 affected6,535 at risk
Myelopathy	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Myoclonus	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Nerve compression	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Nervous system disorder	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Neuralgia	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0012 events1 affected6,535 at risk
Neurological symptom	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0014 events4 affected6,535 at risk
Normal pressure hydrocephalus	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0012 events2 affected6,535 at risk
Paraesthesia	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0012 events2 affected6,535 at risk
Paraparesis	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Paraplegia	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Parkinson's disease	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0012 events2 affected6,535 at risk
Parkinsonism	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Polyneuropathy	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Posterior reversible encephalopathy syndrome	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Presyncope	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0008 events8 affected6,532 at risk EG0015 events5 affected6,535 at risk
Radial nerve palsy	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Radicular pain	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Radiculopathy	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0006 events6 affected6,532 at risk EG0012 events2 affected6,535 at risk
Sciatica	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0004 events4 affected6,532 at risk EG0013 events3 affected6,535 at risk
Seizure	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0004 events4 affected6,532 at risk EG0015 events5 affected6,535 at risk
Somnolence	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Spinal cord compression	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Spinal cord haematoma	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Spinal cord herniation	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Spinal cord infarction	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Spinal cord ischaemia	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Spinal vascular disorder	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Spondylitic myelopathy	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0005 events5 affected6,532 at risk EG0013 events3 affected6,535 at risk
Syncope	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG00033 events32 affected6,532 at risk EG00116 events15 affected6,535 at risk
Thalamic infarction	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0011 events1 affected6,535 at risk
Transient aphasia	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Transient global amnesia	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG00046 events41 affected6,532 at risk EG00145 events41 affected6,535 at risk
Tremor	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0002 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Vascular dementia	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected6,532 at risk EG0010 events0 affected6,535 at risk
Vascular encephalopathy	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0009 events9 affected6,532 at risk EG0011 events1 affected6,535 at risk
Vascular headache	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Vertebrobasilar insufficiency	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0004 events4 affected6,532 at risk EG0012 events2 affected6,535 at risk
Vertebrobasilar stroke	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Vocal cord paralysis	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Device dislocation	Product Issues	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Device failure	Product Issues	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Device lead damage	Product Issues	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Device malfunction	Product Issues	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Device occlusion	Product Issues	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0010 events0 affected6,535 at risk
Device power source issue	Product Issues	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Thrombosis in device	Product Issues	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Acute psychosis	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Anxiety	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0004 events2 affected6,532 at risk EG0012 events2 affected6,535 at risk
Anxiety disorder	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0013 events2 affected6,535 at risk
Bipolar disorder	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0015 events4 affected6,535 at risk
Borderline personality disorder	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Completed suicide	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0012 events2 affected6,535 at risk
Confusional state	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0012 events2 affected6,535 at risk
Conversion disorder	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Delirium	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0013 events3 affected6,535 at risk
Depressed mood	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Depression	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG00014 events10 affected6,532 at risk EG00111 events9 affected6,535 at risk
Depression suicidal	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Insomnia	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Major depression	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0007 events6 affected6,532 at risk EG0013 events3 affected6,535 at risk
Mania	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Mental disorder	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Mental status changes	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0004 events4 affected6,532 at risk EG0015 events5 affected6,535 at risk
Mood disorder due to a general medical condition	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Organic brain syndrome	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Post-traumatic stress disorder	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0002 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Psychotic disorder	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Schizophrenia	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Stress	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Suicidal ideation	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0014 events3 affected6,535 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG00054 events46 affected6,532 at risk EG00159 events53 affected6,535 at risk
Azotaemia	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0013 events3 affected6,535 at risk
Bladder mass	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Bladder outlet obstruction	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Bladder prolapse	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Calculus bladder	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0010 events0 affected6,535 at risk
Calculus urinary	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected6,532 at risk EG0015 events5 affected6,535 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG00016 events15 affected6,532 at risk EG0018 events7 affected6,535 at risk
Cystitis haemorrhagic	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Diabetic nephropathy	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected6,532 at risk EG0012 events2 affected6,535 at risk
Dysuria	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
End stage renal disease	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0006 events4 affected6,532 at risk EG00110 events9 affected6,535 at risk
Genitourinary symptom	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Haematuria	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0008 events8 affected6,532 at risk EG0019 events6 affected6,535 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0006 events6 affected6,532 at risk EG0012 events2 affected6,535 at risk
Hypertensive nephropathy	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Hypertonic bladder	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Ketonuria	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Lower urinary tract symptoms	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0012 events2 affected6,535 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG00018 events15 affected6,532 at risk EG00124 events20 affected6,535 at risk
Nephropathy	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Nephrotic syndrome	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0011 events1 affected6,535 at risk
Renal artery arteriosclerosis	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Renal artery stenosis	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Renal artery thrombosis	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Renal colic	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0004 events3 affected6,532 at risk EG0013 events3 affected6,535 at risk
Renal cyst	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0012 events2 affected6,535 at risk
Renal embolism	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Renal failure	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG00018 events17 affected6,532 at risk EG00117 events16 affected6,535 at risk
Renal haematoma	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Renal haemorrhage	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Renal impairment	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0006 events6 affected6,532 at risk EG0012 events2 affected6,535 at risk
Renal injury	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Renal ischaemia	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Renal mass	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0011 events1 affected6,535 at risk
Stag horn calculus	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Stress urinary incontinence	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Tubulointerstitial nephritis	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Ureteric stenosis	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0010 events0 affected6,535 at risk
Ureterolithiasis	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0009 events8 affected6,532 at risk EG0019 events8 affected6,535 at risk
Urethral haemorrhage	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Urethral stenosis	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0010 events0 affected6,535 at risk
Urinary bladder haemorrhage	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Urinary fistula	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0012 events2 affected6,535 at risk
Urinary retention	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0007 events6 affected6,532 at risk EG0015 events5 affected6,535 at risk
Acquired hydrocele	Reproductive system and breast disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Adenomyosis	Reproductive system and breast disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Adnexal torsion	Reproductive system and breast disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Balanoposthitis	Reproductive system and breast disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 22.1	Systematic Assessment	EG00013 events11 affected6,532 at risk EG00118 events18 affected6,535 at risk
Breast discharge	Reproductive system and breast disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Breast disorder	Reproductive system and breast disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Breast hyperplasia	Reproductive system and breast disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Breast mass	Reproductive system and breast disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Breast pain	Reproductive system and breast disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Endometrial hyperplasia	Reproductive system and breast disorders	MedDRA 22.1	Systematic Assessment	EG0004 events4 affected6,532 at risk EG0010 events0 affected6,535 at risk
Endometrial thickening	Reproductive system and breast disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Endometriosis	Reproductive system and breast disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Epididymal cyst	Reproductive system and breast disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Female genital tract fistula	Reproductive system and breast disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Genital leukoplakia	Reproductive system and breast disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Haemorrhagic ovarian cyst	Reproductive system and breast disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0010 events0 affected6,535 at risk
Pelvic congestion	Reproductive system and breast disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Pelvic fluid collection	Reproductive system and breast disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Pelvic prolapse	Reproductive system and breast disorders	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected6,532 at risk EG0010 events0 affected6,535 at risk
Perineal cyst	Reproductive system and breast disorders	MedDRA 22.1	Systematic Assessment	EG0002 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Peyronie's disease	Reproductive system and breast disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Postmenopausal haemorrhage	Reproductive system and breast disorders	MedDRA 22.1	Systematic Assessment	EG0004 events4 affected6,532 at risk EG0011 events1 affected6,535 at risk
Prostatic disorder	Reproductive system and breast disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Prostatomegaly	Reproductive system and breast disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0013 events2 affected6,535 at risk
Seminal vesiculitis	Reproductive system and breast disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Spermatocele	Reproductive system and breast disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Testicular cyst	Reproductive system and breast disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Testicular mass	Reproductive system and breast disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Uterine polyp	Reproductive system and breast disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0012 events2 affected6,535 at risk
Uterine prolapse	Reproductive system and breast disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0013 events3 affected6,535 at risk
Vaginal fistula	Reproductive system and breast disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Vaginal prolapse	Reproductive system and breast disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0011 events1 affected6,535 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0004 events4 affected6,532 at risk EG0011 events1 affected6,535 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected6,532 at risk EG0010 events0 affected6,535 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG00029 events23 affected6,532 at risk EG00116 events15 affected6,535 at risk
Asphyxia	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0010 events0 affected6,535 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0008 events8 affected6,532 at risk EG00111 events11 affected6,535 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Bronchial hyperreactivity	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Bronchiectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0013 events3 affected6,535 at risk
Bronchitis chronic	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0012 events2 affected6,535 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0010 events0 affected6,535 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG00035 events31 affected6,532 at risk EG00142 events38 affected6,535 at risk
Chronic respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Chylothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0010 events0 affected6,535 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0012 events2 affected6,535 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG00011 events11 affected6,532 at risk EG00117 events15 affected6,535 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected6,532 at risk EG0012 events2 affected6,535 at risk
Emphysema	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Epiglottic cyst	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG00013 events13 affected6,532 at risk EG0017 events7 affected6,535 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected6,532 at risk EG0014 events4 affected6,535 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected6,532 at risk EG0010 events0 affected6,535 at risk
Hypercapnia	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Hypersensitivity pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0013 events3 affected6,535 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0003 events2 affected6,532 at risk EG0010 events0 affected6,535 at risk
Laryngeal oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Laryngospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Nasal septum deviation	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0013 events3 affected6,535 at risk
Organising pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Pharyngeal stenosis	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Pickwickian syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0004 events4 affected6,532 at risk EG0013 events3 affected6,535 at risk
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0008 events6 affected6,532 at risk EG0017 events7 affected6,535 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0012 events2 affected6,535 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0013 events3 affected6,535 at risk
Pneumothorax spontaneous	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected6,532 at risk EG0010 events0 affected6,535 at risk
Pulmonary arterial hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG00023 events23 affected6,532 at risk EG00120 events20 affected6,535 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0015 events3 affected6,535 at risk
Pulmonary infarction	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0007 events7 affected6,532 at risk EG0016 events4 affected6,535 at risk
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0010 events0 affected6,535 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0003 events2 affected6,532 at risk EG0012 events2 affected6,535 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0007 events6 affected6,532 at risk EG00117 events12 affected6,535 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0007 events7 affected6,532 at risk EG0017 events7 affected6,535 at risk
Tonsillar disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Vocal cord polyp	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Acanthosis	Skin and subcutaneous tissue disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Alopecia scarring	Skin and subcutaneous tissue disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0011 events1 affected6,535 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0010 events0 affected6,535 at risk
Dermal cyst	Skin and subcutaneous tissue disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0010 events0 affected6,535 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0012 events2 affected6,535 at risk
Dermatomyositis	Skin and subcutaneous tissue disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA 22.1	Systematic Assessment	EG0007 events6 affected6,532 at risk EG00116 events14 affected6,535 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Erythema multiforme	Skin and subcutaneous tissue disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Granuloma annulare	Skin and subcutaneous tissue disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Henoch-schonlein purpura	Skin and subcutaneous tissue disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Hidradenitis	Skin and subcutaneous tissue disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Hypersensitivity vasculitis	Skin and subcutaneous tissue disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Ischaemic skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0012 events2 affected6,535 at risk
Panniculitis	Skin and subcutaneous tissue disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Skin necrosis	Skin and subcutaneous tissue disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 22.1	Systematic Assessment	EG0009 events8 affected6,532 at risk EG00114 events12 affected6,535 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0010 events0 affected6,535 at risk
Aborted pregnancy	Social circumstances	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Hospitalisation	Surgical and medical procedures	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Accelerated hypertension	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Aneurysm	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0012 events2 affected6,535 at risk
Aortic aneurysm	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG00016 events16 affected6,532 at risk EG00112 events11 affected6,535 at risk
Aortic aneurysm rupture	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0010 events0 affected6,535 at risk
Aortic dissection	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0005 events5 affected6,532 at risk EG0012 events2 affected6,535 at risk
Aortic embolus	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Aortic stenosis	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0008 events8 affected6,532 at risk EG0015 events4 affected6,535 at risk
Arterial occlusive disease	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Arterial stenosis	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Arteriosclerosis	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected6,532 at risk EG0012 events2 affected6,535 at risk
Blood pressure inadequately controlled	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Circulatory collapse	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected6,532 at risk EG0014 events3 affected6,535 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG00015 events14 affected6,532 at risk EG00116 events15 affected6,535 at risk
Diabetic vascular disorder	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0003 events2 affected6,532 at risk EG0011 events1 affected6,535 at risk
Dry gangrene	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0012 events2 affected6,535 at risk
Embolism	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Embolism venous	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Essential hypertension	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0012 events1 affected6,535 at risk
Extremity necrosis	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0016 events5 affected6,535 at risk
Femoral artery perforation	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Haematoma	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0005 events5 affected6,532 at risk EG0010 events0 affected6,535 at risk
Haemodynamic instability	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Hypertension	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG00033 events30 affected6,532 at risk EG00135 events31 affected6,535 at risk
Hypertensive crisis	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG00019 events15 affected6,532 at risk EG00112 events9 affected6,535 at risk
Hypertensive emergency	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0014 events4 affected6,535 at risk
Hypertensive urgency	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0006 events6 affected6,532 at risk EG0014 events4 affected6,535 at risk
Hypotension	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG00011 events11 affected6,532 at risk EG00112 events10 affected6,535 at risk
Hypovolaemic shock	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0014 events4 affected6,535 at risk
Iliac artery occlusion	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0013 events3 affected6,535 at risk
Iliac artery stenosis	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected6,532 at risk EG0012 events2 affected6,535 at risk
Inferior vena cava perforation	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Intermittent claudication	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0004 events4 affected6,532 at risk EG0017 events4 affected6,535 at risk
Jugular vein thrombosis	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Leriche syndrome	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Lymphoedema	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected6,532 at risk EG0013 events3 affected6,535 at risk
Malignant hypertension	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Neurogenic shock	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0004 events4 affected6,532 at risk EG00111 events10 affected6,535 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG00039 events30 affected6,532 at risk EG00152 events45 affected6,535 at risk
Peripheral artery aneurysm	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0004 events3 affected6,532 at risk EG0014 events3 affected6,535 at risk
Peripheral artery aneurysm rupture	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Peripheral artery occlusion	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0008 events7 affected6,532 at risk EG00110 events8 affected6,535 at risk
Peripheral artery stenosis	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0008 events7 affected6,532 at risk EG0015 events3 affected6,535 at risk
Peripheral artery thrombosis	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0004 events4 affected6,532 at risk EG0012 events1 affected6,535 at risk
Peripheral coldness	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG00021 events16 affected6,532 at risk EG00113 events11 affected6,535 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG00020 events13 affected6,532 at risk EG00116 events12 affected6,535 at risk
Peripheral venous disease	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Phlebitis	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Shock	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Subclavian artery stenosis	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Subclavian steal syndrome	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Subclavian vein thrombosis	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk
Thrombophlebitis	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0013 events3 affected6,535 at risk
Thrombosis	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected6,532 at risk EG0011 events1 affected6,535 at risk
Vasculitis	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0011 events1 affected6,535 at risk
Venous thrombosis limb	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected6,532 at risk EG0010 events0 affected6,535 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal discomfort	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG000102 events87 affected6,532 at risk EG00138 events35 affected6,535 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG000104 events90 affected6,532 at risk EG00161 events54 affected6,535 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG00099 events80 affected6,532 at risk EG00168 events59 affected6,535 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001,049 events765 affected6,532 at risk EG001386 events316 affected6,535 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG000104 events89 affected6,532 at risk EG00153 events41 affected6,535 at risk
Nausea	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG000229 events204 affected6,532 at risk EG001126 events110 affected6,535 at risk
Nasopharyngitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG000193 events97 affected6,532 at risk EG001145 events75 affected6,535 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 22.1	Systematic Assessment	EG000150 events147 affected6,532 at risk EG001122 events121 affected6,535 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 22.1	Systematic Assessment	EG000131 events130 affected6,532 at risk EG001155 events153 affected6,535 at risk

ID	Title	Description
BG000	Epanova	Omega-3 carboxylic acid 4 x 1 gram capsule
BG001	Placebo	Corn oil 4 x 1 gram capsule
BG002	Total	Total of all reporting groups