Researching Cardiovascular Events With a Weekly Incretin... | NCT01394952

ID	Type	Description	Link
H9X-MC-GBDJ	Other Identifier	Eli Lilly and Company

Label	Type	Description	Intervention Names
1.5 mg Dulaglutide	Experimental	Administered once weekly, subcutaneously	Drug: Dulaglutide
Placebo	Placebo Comparator	Administered once weekly, subcutaneously	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Dulaglutide	Drug	Administered subcutaneously	1.5 mg Dulaglutide	LY2189265

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants Who Experienced an Event For Time, From Randomization to First Occurrence of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (a Composite Cardiovascular Outcome)	The time from randomization to first occurrence of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (a composite endpoint) was evaluated using time-to-event analysis. The primary analysis model was a Cox proportional hazards regression model for the time to the first occurrence of a primary endpoint event, with treatment as a fixed effect using the intent-to-treat population. The number of participants who experienced a primary cardiovascular (CV) endpoint event is presented.	From randomization to first occurrence or death from any cause or study completion (Median Follow-Up of 5.4 Years)

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants Who Experienced an Event for Time to First Occurrence After Randomization of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke, Individually	The time from randomization to first occurrence of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (individually) was evaluated using time-to-event analysis via the Cox proportional hazards regression model where response equals treatment. Death from CV causes is defined as a death resulting from an acute myocardial infarction (MI), sudden cardiac death, death due to heart failure, death due to stroke, or death due to other CV causes. The number of participants who experienced an event is presented.

Eligibility Module

Name	Affiliation	Role
Call 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559 Mon - Fri 9 AM - 5PM Eastern time (UTC/GMT - 5 hours, EST)	Eli Lilly and Company	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.		Mobile	Alabama	36606

PubMed Identifier	Type	Citation	Retractions
41988866	Derived	Wilson JM, Dage JL, Qian HR, Irelan CL, Crowder HS, Duffin KL, Mintun M, Brooks DA, Gerstein HC, Bethel MA. Dulaglutide and neurodegeneration biomarkers: REWIND post hoc analysis. Alzheimers Dement. 2026 Apr;22(4):e71391. doi: 10.1002/alz.71391.
39963952	Derived	Natale P, Green SC, Tunnicliffe DJ, Pellegrino G, Toyama T, Strippoli GF. Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2025 Feb 18;2(2):CD015849. doi: 10.1002/14651858.CD015849.pub2.

ID	Title	Description
FG000	Placebo	Placebo was administered once weekly, subcutaneously
FG001	Dulaglutide	1.5 mg Dulaglutide was administered once weekly, subcutaneously

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 5, 2016	Apr 8, 2019

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants Who Experienced an Event For Time, From Randomization to First Occurrence of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (a Composite Cardiovascular Outcome)

The time from randomization to first occurrence of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (a composite endpoint) was evaluated using time-to-event analysis. The primary analysis model was a Cox proportional hazards regression model for the time to the first occurrence of a primary endpoint event, with treatment as a fixed effect using the intent-to-treat population. The number of participants who experienced a primary cardiovascular (CV) endpoint event is presented.

All randomized participants.

Posted

Count of Participants

Participants

From randomization to first occurrence or death from any cause or study completion (Median Follow-Up of 5.4 Years)

ID	Title	Description
OG000	Placebo	Placebo was administered once weekly, subcutaneously
OG001	Dulaglutide	1.5 mg Dulaglutide was administered once weekly, subcutaneously

Units	Counts
Participants	OG0004952 OG0014949

Title

Denominators

Categories

Title	Measurements
	OG000663 OG001594

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	Primary CV endpoint	Regression, Cox		0.026		Hazard Ratio (HR)	0.88			2-Sided	95.33	0.79	0.99					Superiority	Superiority was declared if the upper limit of the 2-sided 95.33% confidence interval (CI) of the hazard ratio was below 1.0 (after adjustment for the interim analysis). Once superiority was achieved for the primary endpoint, multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467.

Secondary

Number of Participants Who Experienced an Event for Time to First Occurrence After Randomization of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke, Individually

The time from randomization to first occurrence of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (individually) was evaluated using time-to-event analysis via the Cox proportional hazards regression model where response equals treatment. Death from CV causes is defined as a death resulting from an acute myocardial infarction (MI), sudden cardiac death, death due to heart failure, death due to stroke, or death due to other CV causes. The number of participants who experienced an event is presented.

All randomized participants.

Posted

Count of Participants

Participants

From randomization to first occurrence or study completion (Median Follow-Up of 5.4 Years)

ID	Title	Description
OG000	Placebo	Placebo was administered once weekly, subcutaneously
OG001	Dulaglutide	1.5 mg Dulaglutide was administered once weekly, subcutaneously

Units	Counts
Participants

Secondary

Number of Participants Who Experienced an Event for Time to All-cause Mortality

The time to all-cause mortality was evaluated using time-to-event analysis via the Cox proportional hazards regression model where response equals treatment. The number of participants who experienced an event is presented.

All randomized participants.

Posted

Count of Participants

Participants

From randomization to study completion (Median Follow-Up of 5.4 Years)

ID	Title	Description
OG000	Placebo	Placebo was administered once weekly, subcutaneously
OG001	Dulaglutide	1.5 mg Dulaglutide was administered once weekly, subcutaneously

Units	Counts
Participants	OG000

Secondary

Number of Participants Who Experienced an Event for Time to First Occurrence After Randomization of the Composite Microvascular Endpoint

The time from randomization to first occurrence of the composite microvascular endpoint was evaluated using time-to-event analysis via the Cox proportional hazards regression model where response equals treatment. The composite microvascular endpoint is defined as diabetic retinopathy requiring laser therapy, vitrectomy, or anti-vascular endothelial growth factor therapy (VEGF), clinical proteinuria, a greater than equal ≥ 30% decline in estimated glomerular filtration rate, or need for chronic renal replacement therapy. The number of participants who experienced the composite microvascular endpoint event is presented.

All randomized participants.

Posted

Count of Participants

Participants

From randomization to first occurrence or study completion (Median Follow-Up of 5.4 Years)

ID	Title	Description
OG000	Placebo	Placebo was administered once weekly, subcutaneously
OG001	Dulaglutide	1.5 mg Dulaglutide was administered once weekly, subcutaneously

Units	Counts

Secondary

Number of Participants Who Experienced An Event for Time to First Occurrence After Randomization of Heart Failure Requiring Hospitalization or an Urgent Heart Failure Clinic Visit

The time to first occurrence after randomization of heart failure requiring hospitalization or an urgent heart failure clinic visit was evaluated using time-to-event analysis via the Cox proportional hazards regression model where response equals treatment. The number of participants who experienced an event is presented.

All randomized participants.

Posted

Count of Participants

Participants

From randomization to first occurrence or study completion (Median Follow-Up of 5.4 Years)

ID	Title	Description
OG000	Placebo	Placebo was administered once weekly, subcutaneously
OG001	Dulaglutide	1.5 mg Dulaglutide was administered once weekly, subcutaneously

Units	Counts
Participants	OG000

Secondary

Number of Participants Who Experienced an Event for Time to First Occurrence After Randomization of First Hospitalization for Unstable Angina

Time to first occurrence after randomization of first hospitalization for unstable angina was evaluated using time-to-event analysis via the Cox proportional hazards regression model where response equals treatment. The number of participants who experienced an event is presented.

All randomized participants.

Posted

Count of Participants

Participants

From randomization to first occurrence or study completion (Median Follow-Up of 5.4 Years)

ID	Title	Description
OG000	Placebo	Placebo was administered once weekly, subcutaneously
OG001	Dulaglutide	1.5 mg Dulaglutide was administered once weekly, subcutaneously

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Agranulocytosis	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG00024 events23 affected4,949 at risk EG00130 events29 affected4,943 at risk
Anaemia folate deficiency	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Anaemia macrocytic	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Anaemia of malignant disease	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0012 events2 affected4,943 at risk
Anaemia vitamin b12 deficiency	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Blood disorder	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Deficiency anaemia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0005 events4 affected4,949 at risk EG0012 events2 affected4,943 at risk
Haemolytic anaemia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0010 events0 affected4,943 at risk
Histiocytosis haematophagic	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Hypochromic anaemia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0012 events2 affected4,943 at risk
Immune thrombocytopenic purpura	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG00010 events9 affected4,949 at risk EG00114 events14 affected4,943 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Lymphadenopathy mediastinal	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Microcytic anaemia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Nephrogenic anaemia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Normochromic normocytic anaemia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Normocytic anaemia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0013 events3 affected4,943 at risk
Polycythaemia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Splenic haemorrhage	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Splenomegaly	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0013 events3 affected4,943 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG00043 events41 affected4,949 at risk EG00144 events43 affected4,943 at risk
Acute left ventricular failure	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0013 events3 affected4,943 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG00059 events53 affected4,949 at risk EG00140 events39 affected4,943 at risk
Angina pectoris	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG00067 events58 affected4,949 at risk EG00161 events56 affected4,943 at risk
Angina unstable	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG00058 events54 affected4,949 at risk EG00147 events44 affected4,943 at risk
Aortic valve disease mixed	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Aortic valve incompetence	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0015 events5 affected4,943 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0007 events6 affected4,949 at risk EG0019 events9 affected4,943 at risk
Arrhythmia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0016 events6 affected4,943 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0009 events9 affected4,949 at risk EG0017 events7 affected4,943 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG00079 events62 affected4,949 at risk EG001107 events90 affected4,943 at risk
Atrial flutter	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG00019 events18 affected4,949 at risk EG00119 events15 affected4,943 at risk
Atrial tachycardia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0012 events2 affected4,943 at risk
Atrial thrombosis	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Atrioventricular block	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0006 events6 affected4,949 at risk EG0017 events7 affected4,943 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG00012 events11 affected4,949 at risk EG0018 events8 affected4,943 at risk
Atrioventricular block first degree	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Atrioventricular block second degree	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0009 events9 affected4,949 at risk EG0018 events8 affected4,943 at risk
Bifascicular block	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Bradyarrhythmia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0013 events3 affected4,943 at risk
Bradycardia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG00010 events10 affected4,949 at risk EG00117 events16 affected4,943 at risk
Bundle branch block left	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0010 events0 affected4,943 at risk
Bundle branch block right	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0012 events2 affected4,943 at risk
Cardiac arrest	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG00015 events14 affected4,949 at risk EG00114 events11 affected4,943 at risk
Cardiac disorder	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Cardiac failure	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG000124 events104 affected4,949 at risk EG00187 events78 affected4,943 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG00010 events9 affected4,949 at risk EG00111 events8 affected4,943 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG00024 events21 affected4,949 at risk EG00115 events14 affected4,943 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG00052 events47 affected4,949 at risk EG00142 events38 affected4,943 at risk
Cardiac tamponade	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0007 events7 affected4,949 at risk EG0015 events5 affected4,943 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0015 events5 affected4,943 at risk
Cardiomyopathy	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected4,949 at risk EG0012 events2 affected4,943 at risk
Cardiomyopathy alcoholic	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0012 events2 affected4,943 at risk
Cardiorenal syndrome	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Cardiovascular disorder	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Cardiovascular insufficiency	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Chronic left ventricular failure	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Congestive cardiomyopathy	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0017 events7 affected4,943 at risk
Cor pulmonale	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Coronary artery disease	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG00064 events57 affected4,949 at risk EG00163 events57 affected4,943 at risk
Coronary artery insufficiency	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0011 events1 affected4,943 at risk
Coronary artery perforation	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected4,949 at risk EG0015 events5 affected4,943 at risk
Defect conduction intraventricular	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0010 events0 affected4,943 at risk
Diastolic dysfunction	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Dressler's syndrome	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Extrasystoles	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Gastrocardiac syndrome	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Hypertensive heart disease	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0012 events2 affected4,943 at risk
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG00111 events10 affected4,943 at risk
Left ventricular dysfunction	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0012 events2 affected4,943 at risk
Left ventricular failure	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0008 events8 affected4,949 at risk EG00113 events13 affected4,943 at risk
Metabolic cardiomyopathy	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Microvascular coronary artery disease	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0003 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Mitral valve disease	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0007 events7 affected4,949 at risk EG0019 events9 affected4,943 at risk
Mitral valve prolapse	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Mitral valve stenosis	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Myocardial infarction	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG00037 events35 affected4,949 at risk EG00130 events30 affected4,943 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG00023 events23 affected4,949 at risk EG00120 events19 affected4,943 at risk
Myocarditis	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Nodal rhythm	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Palpitations	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Pericardial effusion	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0012 events2 affected4,943 at risk
Pericarditis	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0006 events6 affected4,949 at risk EG0013 events2 affected4,943 at risk
Prinzmetal angina	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0012 events1 affected4,943 at risk
Right ventricular dysfunction	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Right ventricular failure	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0011 events1 affected4,943 at risk
Silent myocardial infarction	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0012 events2 affected4,943 at risk
Sinoatrial block	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Sinus arrest	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0012 events2 affected4,943 at risk
Sinus bradycardia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0006 events6 affected4,949 at risk EG0012 events2 affected4,943 at risk
Sinus node dysfunction	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0009 events9 affected4,949 at risk EG0016 events6 affected4,943 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Stress cardiomyopathy	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0010 events0 affected4,943 at risk
Supraventricular extrasystoles	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0009 events9 affected4,949 at risk EG0017 events7 affected4,943 at risk
Tachyarrhythmia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Tachycardia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0014 events3 affected4,943 at risk
Tachycardia induced cardiomyopathy	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Tricuspid valve incompetence	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0011 events1 affected4,943 at risk
Ventricular arrhythmia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0014 events4 affected4,943 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0014 events4 affected4,943 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG00010 events5 affected4,949 at risk EG00111 events7 affected4,943 at risk
Adenomatous polyposis coli	Congenital, familial and genetic disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Atrial septal defect	Congenital, familial and genetic disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Chronic granulomatous disease	Congenital, familial and genetic disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Congenital cerebrovascular anomaly	Congenital, familial and genetic disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Developmental hip dysplasia	Congenital, familial and genetic disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Exomphalos	Congenital, familial and genetic disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Gastrointestinal arteriovenous malformation	Congenital, familial and genetic disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Heart disease congenital	Congenital, familial and genetic disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Hereditary motor and sensory neuropathy	Congenital, familial and genetic disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Hydrocele	Congenital, familial and genetic disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected2,667 at risk EG0012 events2 affected2,640 at risk
Hypertrophic cardiomyopathy	Congenital, familial and genetic disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Phimosis	Congenital, familial and genetic disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected2,667 at risk EG0013 events3 affected2,640 at risk
Vascular malformation	Congenital, familial and genetic disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Deafness	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Deafness neurosensory	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0010 events0 affected4,943 at risk
Deafness unilateral	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Hypoacusis	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Sudden hearing loss	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0006 events6 affected4,949 at risk EG0014 events4 affected4,943 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0014 events4 affected4,943 at risk
Vestibular ataxia	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Vestibular disorder	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0011 events1 affected4,943 at risk
Acromegaly	Endocrine disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Adrenocortical insufficiency acute	Endocrine disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Autoimmune thyroiditis	Endocrine disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Cushing's syndrome	Endocrine disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Goitre	Endocrine disorders	MedDRA 21.0	Systematic Assessment	EG0008 events8 affected4,949 at risk EG00112 events12 affected4,943 at risk
Hyperaldosteronism	Endocrine disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Hyperparathyroidism	Endocrine disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0012 events2 affected4,943 at risk
Hyperparathyroidism primary	Endocrine disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Hyperparathyroidism secondary	Endocrine disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0012 events2 affected4,943 at risk
Hypoparathyroidism secondary	Endocrine disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Parathyroid disorder	Endocrine disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Primary hyperaldosteronism	Endocrine disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0012 events1 affected4,943 at risk
Thyroid mass	Endocrine disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0012 events2 affected4,943 at risk
Thyroiditis subacute	Endocrine disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Toxic nodular goitre	Endocrine disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Amaurosis fugax	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Amblyopia	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Angle closure glaucoma	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Blepharochalasis	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Cataract	Eye disorders	MedDRA 21.0	Systematic Assessment	EG00034 events29 affected4,949 at risk EG00127 events19 affected4,943 at risk
Cataract diabetic	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Cataract nuclear	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0004 events3 affected4,949 at risk EG0010 events0 affected4,943 at risk
Cataract subcapsular	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0010 events0 affected4,943 at risk
Dacryostenosis acquired	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0010 events0 affected4,943 at risk
Diabetic retinopathy	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0008 events4 affected4,949 at risk EG0011 events1 affected4,943 at risk
Diplopia	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Eye haemorrhage	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0003 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Glaucoma	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0006 events6 affected4,949 at risk EG0013 events3 affected4,943 at risk
Hypermetropia	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Iridodialysis	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Lens dislocation	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Macular fibrosis	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0012 events2 affected4,943 at risk
Macular hole	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Macular oedema	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Maculopathy	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Neurotrophic keratopathy	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Open angle glaucoma	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected4,949 at risk EG0010 events0 affected4,943 at risk
Ophthalmic vein thrombosis	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Optic ischaemic neuropathy	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Retinal artery embolism	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Retinal artery occlusion	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Retinal detachment	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0014 events3 affected4,943 at risk
Retinal haemorrhage	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Retinal tear	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Strabismus	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Vitreous haemorrhage	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0014 events3 affected4,943 at risk
Abdominal adhesions	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0010 events0 affected4,943 at risk
Abdominal compartment syndrome	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0007 events7 affected4,949 at risk EG0017 events7 affected4,943 at risk
Abdominal hernia obstructive	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Abdominal incarcerated hernia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0010 events0 affected4,943 at risk
Abdominal mass	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00011 events10 affected4,949 at risk EG00112 events10 affected4,943 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected4,949 at risk EG0013 events3 affected4,943 at risk
Abdominal wall haematoma	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Acute abdomen	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Anal fistula	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Anal incontinence	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected4,949 at risk EG0011 events1 affected4,943 at risk
Ascites	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Barrett's oesophagus	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Chronic gastritis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0011 events1 affected4,943 at risk
Colitis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0009 events7 affected4,949 at risk EG0014 events4 affected4,943 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0014 events4 affected4,943 at risk
Colitis microscopic	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0012 events2 affected4,943 at risk
Colitis ulcerative	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0012 events2 affected4,943 at risk
Constipation	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0006 events6 affected4,949 at risk EG0016 events6 affected4,943 at risk
Crohn's disease	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Dental cyst	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Diabetic gastroparesis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Diaphragmatic hernia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0008 events8 affected4,949 at risk EG00110 events10 affected4,943 at risk
Diverticular perforation	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Diverticulum	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0015 events5 affected4,943 at risk
Diverticulum intestinal	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0015 events5 affected4,943 at risk
Diverticulum intestinal haemorrhagic	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0010 events0 affected4,943 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected4,949 at risk EG0013 events3 affected4,943 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0013 events3 affected4,943 at risk
Duodenitis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0011 events1 affected4,943 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0012 events2 affected4,943 at risk
Enteritis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0010 events0 affected4,943 at risk
Enterovesical fistula	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Erosive duodenitis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Faecaloma	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected4,949 at risk EG0010 events0 affected4,943 at risk
Fistula of small intestine	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Food poisoning	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Gallstone ileus	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Gastric dilatation	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Gastric dysplasia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Gastric polyps	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0012 events2 affected4,943 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0007 events7 affected4,949 at risk EG0016 events6 affected4,943 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected4,949 at risk EG0018 events8 affected4,943 at risk
Gastritis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00017 events17 affected4,949 at risk EG00113 events13 affected4,943 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0012 events2 affected4,943 at risk
Gastroduodenitis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0012 events2 affected4,943 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00014 events13 affected4,949 at risk EG00113 events12 affected4,943 at risk
Gastrointestinal inflammation	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Gastrointestinal motility disorder	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Gastrointestinal mucocoele	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Gastrointestinal necrosis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Gastrointestinal polyp	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Gastrointestinal polyp haemorrhage	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Gastrointestinal ulcer	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Gastrointestinal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Gastrointestinal vascular malformation haemorrhagic	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0006 events6 affected4,949 at risk EG0019 events9 affected4,943 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Haemorrhagic erosive gastritis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0012 events2 affected4,943 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0015 events5 affected4,943 at risk
Haemorrhoids thrombosed	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Hernial eventration	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0012 events2 affected4,943 at risk
Heyde's syndrome	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0017 events7 affected4,943 at risk
Ileus	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0011 events1 affected4,943 at risk
Ileus paralytic	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0011 events1 affected4,943 at risk
Impaired gastric emptying	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Incarcerated inguinal hernia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0010 events0 affected4,943 at risk
Incarcerated umbilical hernia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00011 events11 affected4,949 at risk EG00117 events17 affected4,943 at risk
Intestinal haemorrhage	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0012 events1 affected4,943 at risk
Intestinal ischaemia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0012 events2 affected4,943 at risk
Intestinal mass	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00015 events14 affected4,949 at risk EG0019 events9 affected4,943 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Intestinal polyp	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Intestinal stenosis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Intra-abdominal haemorrhage	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Intussusception	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0012 events2 affected4,943 at risk
Irritable bowel syndrome	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected4,949 at risk EG0010 events0 affected4,943 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected4,949 at risk EG0016 events4 affected4,943 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0006 events6 affected4,949 at risk EG0016 events6 affected4,943 at risk
Mallory-weiss syndrome	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Mechanical ileus	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Megacolon	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Melaena	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0012 events2 affected4,943 at risk
Mesenteric arterial occlusion	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Mesenteric artery thrombosis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0010 events0 affected4,943 at risk
Mouth haemorrhage	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Nausea	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0012 events2 affected4,943 at risk
Necrotising oesophagitis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Obstructive pancreatitis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0010 events0 affected4,943 at risk
Oesophageal achalasia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Oesophageal spasm	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Oesophageal stenosis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0013 events2 affected4,943 at risk
Oesophageal varices haemorrhage	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0013 events3 affected4,943 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0012 events2 affected4,943 at risk
Palatal disorder	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Pancreatic cyst	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0011 events1 affected4,943 at risk
Pancreatic pseudocyst	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected4,949 at risk EG0019 events9 affected4,943 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00010 events8 affected4,949 at risk EG00115 events15 affected4,943 at risk
Pancreatitis chronic	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Peptic ulcer	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0012 events2 affected4,943 at risk
Peritoneal adhesions	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Peritoneal haematoma	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Peritoneal hernia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Portal venous gas	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Proctitis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected4,949 at risk EG0015 events5 affected4,943 at risk
Rectal polyp	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0012 events2 affected4,943 at risk
Retroperitoneal haemorrhage	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Salivary gland calculus	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00012 events10 affected4,949 at risk EG0015 events5 affected4,943 at risk
Spigelian hernia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Strangulated umbilical hernia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0011 events1 affected4,943 at risk
Thrombosis mesenteric vessel	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0010 events0 affected4,943 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0007 events7 affected4,949 at risk EG0013 events3 affected4,943 at risk
Umbilical hernia, obstructive	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0010 events0 affected4,943 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00010 events10 affected4,949 at risk EG0017 events7 affected4,943 at risk
Varices oesophageal	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0013 events1 affected4,943 at risk
Volvulus of small bowel	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Vomiting	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected4,949 at risk EG0018 events6 affected4,943 at risk
Adverse drug reaction	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0013 events3 affected4,943 at risk
Asthenia	General disorders	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected4,949 at risk EG0016 events5 affected4,943 at risk
Chest discomfort	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Chest pain	General disorders	MedDRA 21.0	Systematic Assessment	EG00015 events14 affected4,949 at risk EG0017 events7 affected4,943 at risk
Death	General disorders	MedDRA 21.0	Systematic Assessment	EG0009 events9 affected4,949 at risk EG0019 events9 affected4,943 at risk
Device intolerance	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Drug effect increased	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Drug intolerance	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Fatigue	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0013 events3 affected4,943 at risk
Gait disturbance	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
General physical health deterioration	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0014 events4 affected4,943 at risk
Generalised oedema	General disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected4,949 at risk EG0012 events2 affected4,943 at risk
Hernia perforation	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Hyperthermia	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Impaired healing	General disorders	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected4,949 at risk EG0014 events4 affected4,943 at risk
Inflammation	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0012 events2 affected4,943 at risk
Malaise	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Metaplasia	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected4,949 at risk EG0015 events5 affected4,943 at risk
Necrosis	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Non-cardiac chest pain	General disorders	MedDRA 21.0	Systematic Assessment	EG00044 events37 affected4,949 at risk EG00128 events26 affected4,943 at risk
Oedema peripheral	General disorders	MedDRA 21.0	Systematic Assessment	EG0007 events7 affected4,949 at risk EG0014 events4 affected4,943 at risk
Pain	General disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0011 events1 affected4,943 at risk
Peripheral swelling	General disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected4,949 at risk EG0010 events0 affected4,943 at risk
Pyrexia	General disorders	MedDRA 21.0	Systematic Assessment	EG0007 events7 affected4,949 at risk EG0017 events7 affected4,943 at risk
Strangulated hernia	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Sudden cardiac death	General disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0010 events0 affected4,943 at risk
Sudden death	General disorders	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected4,949 at risk EG0013 events3 affected4,943 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0012 events2 affected4,943 at risk
Vascular stent occlusion	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Vascular stent stenosis	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Acute hepatic failure	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Bile duct obstruction	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Bile duct stenosis	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0007 events7 affected4,949 at risk EG0018 events8 affected4,943 at risk
Biliary colic	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Biliary dyspepsia	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Cholangitis	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0016 events6 affected4,943 at risk
Cholangitis acute	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0013 events3 affected4,943 at risk
Cholangitis chronic	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG00015 events15 affected4,949 at risk EG00128 events25 affected4,943 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG00017 events17 affected4,949 at risk EG00127 events26 affected4,943 at risk
Cholecystitis chronic	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0017 events7 affected4,943 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG00051 events49 affected4,949 at risk EG00143 events42 affected4,943 at risk
Cholestasis	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0012 events2 affected4,943 at risk
Drug-induced liver injury	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0011 events1 affected4,943 at risk
Gallbladder cholesterolosis	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Gallbladder necrosis	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Gallbladder perforation	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0012 events2 affected4,943 at risk
Gallbladder polyp	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected4,949 at risk EG0015 events5 affected4,943 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0011 events1 affected4,943 at risk
Hepatic mass	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Hepatic steatosis	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Hepatitis	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Hepatorenal syndrome	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Ischaemic hepatitis	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Jaundice	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Jaundice cholestatic	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0011 events1 affected4,943 at risk
Liver disorder	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Non-alcoholic fatty liver	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Non-alcoholic steatohepatitis	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Portal hypertension	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Portal vein thrombosis	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Post cholecystectomy syndrome	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0012 events2 affected4,943 at risk
Anaphylactic reaction	Immune system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0010 events0 affected4,943 at risk
Anti-neutrophil cytoplasmic antibody positive vasculitis	Immune system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Contrast media allergy	Immune system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Hypersensitivity	Immune system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Immunodeficiency	Immune system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Sarcoidosis	Immune system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Abdominal abscess	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0011 events1 affected4,943 at risk
Abscess	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Abscess intestinal	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Abscess limb	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0004 events3 affected4,949 at risk EG0014 events3 affected4,943 at risk
Abscess neck	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Abscess oral	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Anal abscess	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected4,949 at risk EG0014 events4 affected4,943 at risk
Anal infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Aortitis salmonella	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Appendiceal abscess	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Appendicitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0016 events6 affected4,943 at risk
Appendicitis perforated	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Arthritis bacterial	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected4,949 at risk EG0011 events1 affected4,943 at risk
Arthritis infective	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected4,949 at risk EG0012 events2 affected4,943 at risk
Atypical pneumonia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Bacteraemia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0006 events6 affected4,949 at risk EG0012 events2 affected4,943 at risk
Bacterial infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Biliary sepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Brain abscess	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Breast abscess	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Breast cellulitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Bronchitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00012 events12 affected4,949 at risk EG00113 events13 affected4,943 at risk
Bronchitis bacterial	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Bronchitis fungal	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Bronchitis viral	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Burn infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Campylobacter gastroenteritis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0012 events2 affected4,943 at risk
Candida sepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Candiduria	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Carbuncle	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0010 events0 affected4,943 at risk
Cellulitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00048 events42 affected4,949 at risk EG00139 events38 affected4,943 at risk
Cellulitis streptococcal	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Cervicitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected2,282 at risk EG0011 events1 affected2,303 at risk
Cholecystitis infective	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0012 events2 affected4,943 at risk
Chronic hepatitis b	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Clostridium colitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0016 events5 affected4,943 at risk
Clostridium difficile infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0012 events2 affected4,943 at risk
Corneal abscess	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Cystitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0006 events6 affected4,949 at risk EG0013 events3 affected4,943 at risk
Cystitis escherichia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Cytomegalovirus colitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Dengue fever	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0010 events0 affected4,943 at risk
Dengue haemorrhagic fever	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Device related infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0016 events3 affected4,943 at risk
Device related sepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Diabetic foot infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected4,949 at risk EG0011 events1 affected4,943 at risk
Diabetic gangrene	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0012 events1 affected4,943 at risk
Diarrhoea infectious	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Diverticulitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00012 events10 affected4,949 at risk EG00117 events15 affected4,943 at risk
Dysentery	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Echinococciasis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Empyema	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Endocarditis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0015 events4 affected4,943 at risk
Endocarditis bacterial	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Enterococcal sepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Enterocolitis bacterial	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Epididymitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected2,667 at risk EG0014 events4 affected2,640 at risk
Erysipelas	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00018 events15 affected4,949 at risk EG00112 events11 affected4,943 at risk
Escherichia bacteraemia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0013 events3 affected4,943 at risk
Escherichia sepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0010 events0 affected4,943 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0012 events2 affected4,943 at risk
Extradural abscess	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Gallbladder abscess	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0010 events0 affected4,943 at risk
Gallbladder empyema	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Gangrene	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00011 events11 affected4,949 at risk EG00118 events8 affected4,943 at risk
Gastroenteritis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00010 events10 affected4,949 at risk EG00122 events21 affected4,943 at risk
Gastroenteritis clostridial	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0012 events2 affected4,943 at risk
Gastroenteritis norovirus	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected4,949 at risk EG0012 events2 affected4,943 at risk
Gastrointestinal infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Genitourinary tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Groin abscess	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
H1n1 influenza	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Haematoma infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0012 events2 affected4,943 at risk
Helicobacter gastritis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Helicobacter infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0010 events0 affected4,943 at risk
Hepatitis b	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Hepatitis c	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Hepatitis e	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Hepatitis infectious mononucleosis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Herpes zoster	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected4,949 at risk EG0010 events0 affected4,943 at risk
Herpes zoster meningoencephalitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Herpes zoster pharyngitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Hydrocele male infected	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected2,667 at risk EG0011 events1 affected2,640 at risk
Implant site infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0012 events2 affected4,943 at risk
Infected skin ulcer	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0014 events4 affected4,943 at risk
Infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Infectious colitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0008 events6 affected4,949 at risk EG0013 events3 affected4,943 at risk
Influenza	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0008 events8 affected4,949 at risk EG0015 events5 affected4,943 at risk
Injection site abscess	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Intervertebral discitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Intestinal sepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Joint abscess	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0011 events1 affected4,943 at risk
Kidney infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Labyrinthitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Laryngitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Liver abscess	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0014 events4 affected4,943 at risk
Localised infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0008 events8 affected4,949 at risk EG0018 events8 affected4,943 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00012 events11 affected4,949 at risk EG00113 events12 affected4,943 at risk
Lower respiratory tract infection bacterial	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Lower respiratory tract infection viral	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Lung abscess	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Lung infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0013 events3 affected4,943 at risk
Lymphangitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Mastitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Mastoiditis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Mediastinitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Medical device site infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Medical device site joint infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Meningitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Meningitis aseptic	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Myiasis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Necrotising fasciitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0011 events1 affected4,943 at risk
Neutropenic sepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0012 events2 affected4,943 at risk
Oesophageal candidiasis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Orchitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected2,667 at risk EG0013 events3 affected2,640 at risk
Osteomyelitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00013 events11 affected4,949 at risk EG00111 events10 affected4,943 at risk
Osteomyelitis acute	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0012 events2 affected4,943 at risk
Osteomyelitis chronic	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0012 events2 affected4,943 at risk
Otitis externa	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Otitis media chronic	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Pancreatic abscess	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Paronychia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0012 events2 affected4,943 at risk
Pelvic abscess	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Pelvic infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Perihepatic abscess	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Perineal abscess	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0010 events0 affected4,943 at risk
Periodontitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Perirectal abscess	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Peritonitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0013 events3 affected4,943 at risk
Pharyngeal abscess	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Pneumonia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG000174 events151 affected4,949 at risk EG001152 events135 affected4,943 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0012 events2 affected4,943 at risk
Pneumonia influenzal	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Pneumonia klebsiella	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Pneumonia legionella	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Pneumonia streptococcal	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0011 events1 affected4,943 at risk
Pneumonia viral	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Post procedural infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0013 events3 affected4,943 at risk
Post procedural pneumonia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Post procedural sepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0012 events2 affected4,943 at risk
Postoperative abscess	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Postoperative wound infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0017 events7 affected4,943 at risk
Pseudomonal sepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Pulmonary mycosis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Pulmonary sepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0014 events4 affected4,943 at risk
Pulmonary tuberculosis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Pyelitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Pyelonephritis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00015 events15 affected4,949 at risk EG0018 events8 affected4,943 at risk
Pyelonephritis acute	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0008 events8 affected4,949 at risk EG0017 events7 affected4,943 at risk
Pyelonephritis chronic	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Pyonephrosis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Renal abscess	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Renal cyst infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Respiratory syncytial virus infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Respiratory tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0013 events3 affected4,943 at risk
Salmonella sepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Salmonellosis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Scrotal infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected2,667 at risk EG0010 events0 affected2,640 at risk
Sepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00037 events35 affected4,949 at risk EG00133 events30 affected4,943 at risk
Septic shock	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00024 events22 affected4,949 at risk EG00116 events15 affected4,943 at risk
Sinusitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Skin graft infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Skin infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0011 events1 affected4,943 at risk
Soft tissue infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0010 events0 affected4,943 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0010 events0 affected4,943 at risk
Staphylococcal infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0012 events2 affected4,943 at risk
Staphylococcal mediastinitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Staphylococcal skin infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0010 events0 affected4,943 at risk
Streptococcal bacteraemia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Subcutaneous abscess	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0013 events3 affected4,943 at risk
Subdiaphragmatic abscess	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0013 events1 affected4,943 at risk
Systemic candida	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Tooth abscess	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Tracheobronchitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Tuberculosis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected4,949 at risk EG0010 events0 affected4,943 at risk
Tuberculosis gastrointestinal	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected4,949 at risk EG0012 events2 affected4,943 at risk
Urinary tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00065 events61 affected4,949 at risk EG00178 events64 affected4,943 at risk
Urinary tract infection bacterial	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0012 events2 affected4,943 at risk
Urinary tract infection pseudomonal	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0010 events0 affected4,943 at risk
Urosepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00020 events19 affected4,949 at risk EG00126 events24 affected4,943 at risk
Vestibular neuronitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0014 events4 affected4,943 at risk
Viraemia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Viral infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0010 events0 affected4,943 at risk
Viral myocarditis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Wound infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected4,949 at risk EG0011 events1 affected4,943 at risk
Wound sepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0011 events1 affected4,943 at risk
Accident	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Accident at work	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Accidental overdose	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0018 events8 affected4,943 at risk
Acetabulum fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Alcohol poisoning	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0011 events1 affected4,943 at risk
Anaemia postoperative	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Anastomotic complication	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Anastomotic leak	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0012 events2 affected4,943 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG00020 events20 affected4,949 at risk EG00121 events21 affected4,943 at risk
Arterial injury	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Arteriovenous fistula occlusion	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Back injury	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Brain contusion	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Burns second degree	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Burns third degree	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Carbon monoxide poisoning	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Cartilage injury	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0014 events4 affected4,943 at risk
Chemical poisoning	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0012 events2 affected4,943 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0014 events4 affected4,943 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0016 events6 affected4,943 at risk
Coronary vascular graft occlusion	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected4,949 at risk EG0017 events7 affected4,943 at risk
Craniofacial fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Deep vein thrombosis postoperative	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Delayed recovery from anaesthesia	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Failure to anastomose	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG000137 events124 affected4,949 at risk EG001123 events110 affected4,943 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0007 events7 affected4,949 at risk EG0014 events4 affected4,943 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG00022 events21 affected4,949 at risk EG00118 events18 affected4,943 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0015 events5 affected4,943 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected4,949 at risk EG0013 events3 affected4,943 at risk
Forearm fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0011 events1 affected4,943 at risk
Foreign body	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Foreign body aspiration	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Foreign body in gastrointestinal tract	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Gastroenteritis radiation	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Gastrointestinal injury	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Gastrointestinal stoma complication	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Graft thrombosis	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Gun shot wound	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0011 events1 affected4,943 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0012 events2 affected4,943 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG00017 events17 affected4,949 at risk EG00112 events12 affected4,943 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG00020 events20 affected4,949 at risk EG00112 events12 affected4,943 at risk
Hyphaema	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0007 events6 affected4,949 at risk EG0016 events6 affected4,943 at risk
Incisional hernia, obstructive	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Intentional overdose	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0003 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Intestinal anastomosis complication	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0014 events2 affected4,943 at risk
Jaw fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0006 events4 affected4,949 at risk EG0015 events5 affected4,943 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0011 events1 affected4,943 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0014 events4 affected4,943 at risk
Ligament rupture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0012 events2 affected4,943 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0013 events3 affected4,943 at risk
Limb crushing injury	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0015 events5 affected4,943 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0015 events5 affected4,943 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0012 events2 affected4,943 at risk
Lumbosacral plexus injury	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0012 events1 affected4,943 at risk
Meniscus injury	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected4,949 at risk EG00112 events12 affected4,943 at risk
Multiple fractures	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0013 events3 affected4,943 at risk
Multiple injuries	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0012 events2 affected4,943 at risk
Muscle rupture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0011 events1 affected4,943 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0012 events2 affected4,943 at risk
Patella fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0011 events1 affected4,943 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0016 events6 affected4,943 at risk
Periprosthetic fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0012 events2 affected4,943 at risk
Pneumothorax traumatic	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0010 events0 affected4,943 at risk
Post concussion syndrome	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0010 events0 affected4,943 at risk
Post procedural bile leak	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Post procedural complication	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0012 events2 affected4,943 at risk
Post procedural discharge	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0010 events0 affected4,943 at risk
Post procedural haematuria	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0010 events0 affected4,943 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0017 events7 affected4,943 at risk
Post procedural swelling	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Post-traumatic pain	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Postoperative adhesion	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Postoperative delirium	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Postoperative thoracic procedure complication	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0013 events2 affected4,943 at risk
Postoperative wound complication	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Procedural hypotension	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0010 events0 affected4,943 at risk
Pubis fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0012 events2 affected4,943 at risk
Radiation pneumonitis	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0011 events1 affected4,943 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0006 events6 affected4,949 at risk EG0018 events8 affected4,943 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG00014 events14 affected4,949 at risk EG00110 events10 affected4,943 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG00010 events9 affected4,949 at risk EG00113 events13 affected4,943 at risk
Scapula fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0013 events3 affected4,943 at risk
Sciatic nerve injury	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0010 events0 affected4,943 at risk
Scrotal haematoma	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected2,667 at risk EG0010 events0 affected2,640 at risk
Skin injury	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Skull fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Skull fractured base	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Soft tissue injury	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0014 events4 affected4,943 at risk
Spinal cord injury cervical	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0010 events0 affected4,943 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0012 events2 affected4,943 at risk
Splenic rupture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Stab wound	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Sternal fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Stoma site haemorrhage	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Subarachnoid haemorrhage	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0017 events7 affected4,943 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0007 events7 affected4,949 at risk EG0018 events7 affected4,943 at risk
Subdural haemorrhage	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0010 events0 affected4,943 at risk
Suture rupture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Tendon injury	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0013 events3 affected4,943 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0004 events3 affected4,949 at risk EG0013 events3 affected4,943 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0010 events0 affected4,943 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected4,949 at risk EG0014 events4 affected4,943 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0008 events8 affected4,949 at risk EG0014 events4 affected4,943 at risk
Tongue injury	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected4,949 at risk EG0011 events1 affected4,943 at risk
Transfusion-related acute lung injury	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Traumatic fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Traumatic haematoma	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0013 events3 affected4,943 at risk
Traumatic haemothorax	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Traumatic intracranial haemorrhage	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0012 events2 affected4,943 at risk
Ulna fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0012 events2 affected4,943 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0015 events5 affected4,943 at risk
Vascular graft occlusion	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0014 events4 affected4,943 at risk
Wound	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0012 events1 affected4,943 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Wound secretion	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected4,949 at risk EG0012 events2 affected4,943 at risk
Amylase increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Anticoagulation drug level above therapeutic	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Blood calcitonin increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Blood calcium increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Blood creatinine increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Blood glucose decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Blood glucose fluctuation	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0013 events3 affected4,943 at risk
Blood glucose increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected4,949 at risk EG0016 events5 affected4,943 at risk
Blood pressure increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
C-reactive protein increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Coagulation test abnormal	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Electrocardiogram abnormal	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Glomerular filtration rate decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Glycosylated haemoglobin increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0012 events2 affected4,943 at risk
Haemoglobin decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0010 events0 affected4,943 at risk
Hepatic enzyme increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Oxygen saturation decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Transaminases increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Troponin increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0012 events2 affected4,943 at risk
Troponin t increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Urine albumin/creatinine ratio increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Weight decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected4,949 at risk EG0010 events0 affected4,943 at risk
Abnormal loss of weight	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Cachexia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0011 events1 affected4,943 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG00015 events14 affected4,949 at risk EG00124 events23 affected4,943 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0014 events4 affected4,943 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0016 events6 affected4,943 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0012 events2 affected4,943 at risk
Food intolerance	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Gout	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected4,949 at risk EG0014 events4 affected4,943 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0011 events1 affected4,943 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG00075 events67 affected4,949 at risk EG00152 events46 affected4,943 at risk
Hyperglycaemic hyperosmolar nonketotic syndrome	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0012 events2 affected4,943 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG00012 events12 affected4,949 at risk EG0019 events8 affected4,943 at risk
Hyperosmolar state	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG00080 events72 affected4,949 at risk EG00169 events62 affected4,943 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected4,949 at risk EG0016 events6 affected4,943 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0012 events2 affected4,943 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG00012 events11 affected4,949 at risk EG0018 events8 affected4,943 at risk
Iron deficiency	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Ketoacidosis	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Lactic acidosis	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0010 events0 affected4,943 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0011 events1 affected4,943 at risk
Obesity	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected4,949 at risk EG0015 events5 affected4,943 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0006 events6 affected4,949 at risk EG0019 events9 affected4,943 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0007 events7 affected4,949 at risk EG0016 events6 affected4,943 at risk
Arthritis reactive	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Arthrofibrosis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Articular calcification	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG00010 events9 affected4,949 at risk EG0016 events6 affected4,943 at risk
Bone lesion	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0012 events2 affected4,943 at risk
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0015 events5 affected4,943 at risk
Chondrocalcinosis pyrophosphate	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0012 events1 affected4,943 at risk
Chondromalacia	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0012 events1 affected4,943 at risk
Chondropathy	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0010 events0 affected4,943 at risk
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Diabetic amyotrophy	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Diabetic arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Dupuytren's contracture	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Exostosis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Fistula	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0012 events2 affected4,943 at risk
Fracture malunion	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Gouty arthritis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0010 events0 affected4,943 at risk
Gouty tophus	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0010 events0 affected4,943 at risk
Intervertebral disc disorder	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0013 events3 affected4,943 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG00022 events21 affected4,949 at risk EG00116 events15 affected4,943 at risk
Joint ankylosis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Joint noise	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG00014 events11 affected4,949 at risk EG00110 events10 affected4,943 at risk
Mobility decreased	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Muscle haemorrhage	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0006 events6 affected4,949 at risk EG00110 events10 affected4,943 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0012 events2 affected4,943 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0010 events0 affected4,943 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0010 events0 affected4,943 at risk
Neuropathic arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0010 events0 affected4,943 at risk
Osteitis deformans	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG000128 events110 affected4,949 at risk EG001155 events136 affected4,943 at risk
Osteochondrosis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0014 events4 affected4,943 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0014 events4 affected4,943 at risk
Osteopenia	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0012 events2 affected4,943 at risk
Patellofemoral pain syndrome	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0012 events2 affected4,943 at risk
Periarthritis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0013 events3 affected4,943 at risk
Plantar fascial fibromatosis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Polymyalgia rheumatica	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0010 events0 affected4,943 at risk
Pseudarthrosis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0012 events2 affected4,943 at risk
Rheumatic disorder	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0013 events3 affected4,943 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG00011 events10 affected4,949 at risk EG0018 events8 affected4,943 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0007 events7 affected4,949 at risk EG00113 events13 affected4,943 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG00023 events21 affected4,949 at risk EG00119 events16 affected4,943 at risk
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected4,949 at risk EG0015 events5 affected4,943 at risk
Spondylitis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0011 events1 affected4,943 at risk
Spondyloarthropathy	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0016 events6 affected4,943 at risk
Spondylolysis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0012 events2 affected4,943 at risk
Synovitis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0012 events2 affected4,943 at risk
Tendon disorder	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Tenosynovitis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0012 events1 affected4,943 at risk
Vertebral foraminal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Vertebral osteophyte	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0012 events2 affected4,943 at risk
Adenocarcinoma gastric	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG00011 events10 affected4,949 at risk EG0017 events7 affected4,943 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG00014 events14 affected4,949 at risk EG00117 events17 affected4,943 at risk
Adenocarcinoma of the cervix	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected2,282 at risk EG0011 events1 affected2,303 at risk
Adenocarcinoma pancreas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0014 events4 affected4,943 at risk
Adenoma benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Adenosquamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Adrenal adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0013 events3 affected4,943 at risk
Adrenal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0012 events2 affected4,943 at risk
Anal squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Anaplastic astrocytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Anogenital warts	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Astrocytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0012 events2 affected4,943 at risk
B-cell lymphoma stage i	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
B-cell lymphoma stage ii	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
B-cell small lymphocytic lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0012 events2 affected4,943 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG00011 events11 affected4,949 at risk EG0017 events7 affected4,943 at risk
Benign gastric neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0012 events1 affected4,943 at risk
Benign hepatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Benign neoplasm of adrenal gland	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Benign neoplasm of thyroid gland	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Bile duct adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Bile duct cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0013 events3 affected4,943 at risk
Biliary cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0006 events6 affected4,949 at risk EG0015 events5 affected4,943 at risk
Bladder cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Bladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected4,949 at risk EG0011 events1 affected4,943 at risk
Bladder papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0006 events6 affected4,949 at risk EG0013 events3 affected4,943 at risk
Bladder transitional cell carcinoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Bladder transitional cell carcinoma stage i	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Bone cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Bone cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Bone neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Borderline ovarian tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected2,282 at risk EG0011 events1 affected2,303 at risk
Bowen's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Brain neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0011 events1 affected4,943 at risk
Brain neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0008 events8 affected4,949 at risk EG00111 events11 affected4,943 at risk
Breast cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0012 events2 affected4,943 at risk
Breast cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Breast cancer stage iii	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Brenner tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected2,282 at risk EG0011 events1 affected2,303 at risk
Bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0012 events2 affected4,943 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Carcinoid tumour pulmonary	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0012 events2 affected4,943 at risk
Cardiac myxoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Cerebral haemangioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Cervix carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected2,282 at risk EG0014 events4 affected2,303 at risk
Cervix carcinoma stage 0	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected2,282 at risk EG0010 events0 affected2,303 at risk
Cholangiocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected4,949 at risk EG0014 events4 affected4,943 at risk
Chronic lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0014 events4 affected4,943 at risk
Chronic myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Clear cell renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0016 events6 affected4,943 at risk
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0009 events8 affected4,949 at risk EG0015 events5 affected4,943 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected4,949 at risk EG0016 events6 affected4,943 at risk
Colon cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0012 events2 affected4,943 at risk
Colon cancer stage ii	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Colon cancer stage iv	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Colon neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0010 events0 affected4,943 at risk
Colorectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Colorectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0012 events2 affected4,943 at risk
Colorectal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Diffuse large b-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0013 events3 affected4,943 at risk
Diffuse large b-cell lymphoma stage iv	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0012 events2 affected4,943 at risk
Ductal adenocarcinoma of pancreas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Endometrial adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0009 events9 affected2,282 at risk EG0017 events6 affected2,303 at risk
Endometrial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected2,282 at risk EG0013 events3 affected2,303 at risk
Extranodal marginal zone b-cell lymphoma (malt type)	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0012 events2 affected4,943 at risk
Fibroadenoma of breast	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Fibrosarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Gallbladder cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Gallbladder squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected4,949 at risk EG0016 events6 affected4,943 at risk
Gastric neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0011 events1 affected4,943 at risk
Gastrointestinal stromal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Gastrointestinal stromal tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Glioblastoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0010 events0 affected4,943 at risk
Hepatic angiosarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Hepatic cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected4,949 at risk EG0012 events2 affected4,943 at risk
Hepatic cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0012 events2 affected4,943 at risk
Hepatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Hepatocellular carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0006 events6 affected4,949 at risk EG0011 events1 affected4,943 at risk
Hodgkin's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Huerthle cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Intraductal proliferative breast lesion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Invasive breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG00011 events11 affected4,949 at risk EG0017 events7 affected4,943 at risk
Invasive lobular breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Keratoacanthoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0012 events2 affected4,943 at risk
Large intestine benign neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Laryngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0011 events1 affected4,943 at risk
Laryngeal squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0011 events1 affected4,943 at risk
Leiomyosarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Leiomyosarcoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Lip squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Liposarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Liposarcoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0008 events8 affected4,949 at risk EG0017 events6 affected4,943 at risk
Lung adenocarcinoma stage ii	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Lung adenocarcinoma stage iii	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Lung adenocarcinoma stage iv	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0012 events2 affected4,943 at risk
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0013 events3 affected4,943 at risk
Lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0010 events0 affected4,943 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0006 events6 affected4,949 at risk EG0019 events9 affected4,943 at risk
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0013 events2 affected4,943 at risk
Malignant joint neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected4,949 at risk EG0015 events5 affected4,943 at risk
Malignant melanoma stage iii	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Malignant neoplasm of ampulla of vater	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Malignant pleural effusion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0010 events0 affected4,943 at risk
Mediastinum neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Medullary thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Meningeal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0012 events2 affected4,943 at risk
Mesothelioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Mesothelioma malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Metastases to adrenals	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0011 events1 affected4,943 at risk
Metastases to chest wall	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Metastases to kidney	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected4,949 at risk EG0017 events7 affected4,943 at risk
Metastases to lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0006 events6 affected4,949 at risk EG0011 events1 affected4,943 at risk
Metastases to lymph nodes	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected4,949 at risk EG0011 events1 affected4,943 at risk
Metastases to pelvis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Metastases to peritoneum	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0013 events3 affected4,943 at risk
Metastases to pleura	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Metastatic bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Metastatic gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0012 events2 affected4,943 at risk
Metastatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected4,949 at risk EG0012 events2 affected4,943 at risk
Metastatic renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0013 events3 affected4,943 at risk
Nasal sinus cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0012 events2 affected4,943 at risk
Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0010 events0 affected4,943 at risk
Neoplasm prostate	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected2,667 at risk EG0013 events3 affected2,640 at risk
Neuroendocrine carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0011 events1 affected4,943 at risk
Neuroendocrine carcinoma of the skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Neuroendocrine tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0011 events1 affected4,943 at risk
Non-hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0010 events0 affected4,943 at risk
Non-small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Non-small cell lung cancer stage ii	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Non-small cell lung cancer stage iv	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Oesophageal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0012 events2 affected4,943 at risk
Oesophageal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0013 events3 affected4,943 at risk
Oesophageal squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Ovarian adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected2,282 at risk EG0010 events0 affected2,303 at risk
Ovarian cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected2,282 at risk EG0010 events0 affected2,303 at risk
Ovarian cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected2,282 at risk EG0010 events0 affected2,303 at risk
Ovarian cancer stage iii	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected2,282 at risk EG0010 events0 affected2,303 at risk
Ovarian epithelial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected2,282 at risk EG0012 events2 affected2,303 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected4,949 at risk EG0018 events8 affected4,943 at risk
Pancreatic carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected4,949 at risk EG0014 events4 affected4,943 at risk
Pancreatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0012 events2 affected4,943 at risk
Papillary thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0014 events4 affected4,943 at risk
Paraganglion neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Parathyroid tumour benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Penile squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected2,667 at risk EG0010 events0 affected2,640 at risk
Pericardial effusion malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Phaeochromocytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Pituitary tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Pituitary tumour benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0012 events2 affected4,943 at risk
Plasma cell leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0016 events5 affected4,943 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG00034 events33 affected2,667 at risk EG00133 events33 affected2,640 at risk
Prostate cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected2,667 at risk EG0012 events2 affected2,640 at risk
Prostate cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected2,667 at risk EG0011 events1 affected2,640 at risk
Prostate cancer stage i	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected2,667 at risk EG0010 events0 affected2,640 at risk
Prostatic adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected2,667 at risk EG0016 events6 affected2,640 at risk
Rectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0014 events4 affected4,943 at risk
Rectal adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0012 events2 affected4,943 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0010 events0 affected4,943 at risk
Rectal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Rectal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Rectosigmoid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected4,949 at risk EG0015 events5 affected4,943 at risk
Renal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0010 events0 affected4,943 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0007 events7 affected4,949 at risk EG0014 events4 affected4,943 at risk
Renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0012 events2 affected4,943 at risk
Renal oncocytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0010 events0 affected4,943 at risk
Sarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0016 events6 affected4,943 at risk
Small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Spinal meningioma benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Spindle cell sarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0014 events4 affected4,943 at risk
Squamous cell carcinoma of lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0008 events7 affected4,949 at risk EG0013 events3 affected4,943 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0004 events3 affected4,949 at risk EG0013 events3 affected4,943 at risk
Squamous cell carcinoma of the cervix	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected2,282 at risk EG0011 events1 affected2,303 at risk
Squamous cell carcinoma of the vagina	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected2,282 at risk EG0011 events1 affected2,303 at risk
Squamous cell carcinoma of the vulva	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected2,282 at risk EG0012 events2 affected2,303 at risk
Sweat gland tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0012 events1 affected4,943 at risk
Throat cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Thymoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Thyroid adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Tongue carcinoma stage iv	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Tongue neoplasm malignant stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Tonsil cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0010 events0 affected4,943 at risk
Transitional cell cancer of the renal pelvis and ureter	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0017 events7 affected4,943 at risk
Transitional cell carcinoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Tumour associated fever	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Tumour of ampulla of vater	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Urethral cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Uterine cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected2,282 at risk EG0014 events4 affected2,303 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected2,282 at risk EG0013 events3 affected2,303 at risk
Uterine neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected2,282 at risk EG0011 events1 affected2,303 at risk
Vascular neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Acoustic neuritis	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Altered state of consciousness	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0012 events2 affected4,943 at risk
Amnesia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Amputation stump pain	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Aphasia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0013 events3 affected4,943 at risk
Ataxia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0011 events1 affected4,943 at risk
Autonomic nervous system imbalance	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Balance disorder	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Basal ganglia haemorrhage	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Brain injury	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Brain stem haemorrhage	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Brain stem infarction	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Carotid arteriosclerosis	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Carotid artery occlusion	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected4,949 at risk EG0011 events1 affected4,943 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG00010 events9 affected4,949 at risk EG0015 events5 affected4,943 at risk
Carotid sinus syndrome	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected4,949 at risk EG0011 events1 affected4,943 at risk
Cauda equina syndrome	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Cerebellar ataxia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Cerebellar atrophy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Cerebellar infarction	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Cerebral arteriosclerosis	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Cerebral atrophy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Cerebral circulatory failure	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Cerebral haematoma	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0012 events2 affected4,943 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0012 events2 affected4,943 at risk
Cerebral infarction	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected4,949 at risk EG0015 events5 affected4,943 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected4,949 at risk EG0015 events5 affected4,943 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG00034 events31 affected4,949 at risk EG00125 events24 affected4,943 at risk
Cerebrovascular disorder	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0013 events3 affected4,943 at risk
Cerebrovascular insufficiency	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0011 events1 affected4,943 at risk
Cervical radiculopathy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Cervicobrachial syndrome	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Cognitive disorder	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0012 events2 affected4,943 at risk
Coma	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0012 events2 affected4,943 at risk
Dementia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0014 events4 affected4,943 at risk
Dementia alzheimer's type	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0011 events1 affected4,943 at risk
Demyelinating polyneuropathy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Depressed level of consciousness	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Diabetic coma	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Diabetic hyperglycaemic coma	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Diabetic hyperosmolar coma	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Diabetic mononeuropathy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Diabetic neuropathy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0008 events8 affected4,949 at risk EG0013 events3 affected4,943 at risk
Dizziness	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0019 events9 affected4,943 at risk
Dizziness postural	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Dysarthria	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Embolic stroke	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Encephalopathy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0014 events4 affected4,943 at risk
Epilepsy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0008 events8 affected4,949 at risk EG0011 events1 affected4,943 at risk
Facial paralysis	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0015 events5 affected4,943 at risk
Frontal lobe epilepsy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Generalised tonic-clonic seizure	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0012 events1 affected4,943 at risk
Guillain-barre syndrome	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0013 events3 affected4,943 at risk
Haemorrhagic cerebral infarction	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Haemorrhagic stroke	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0014 events4 affected4,943 at risk
Headache	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0012 events2 affected4,943 at risk
Hemiparesis	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected4,949 at risk EG0011 events1 affected4,943 at risk
Hemiplegia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0010 events0 affected4,943 at risk
Hepatic encephalopathy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Hydrocephalus	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0006 events4 affected4,949 at risk EG0011 events1 affected4,943 at risk
Hypertensive encephalopathy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0011 events1 affected4,943 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Iiird nerve paralysis	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Intracranial aneurysm	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0013 events2 affected4,943 at risk
Intracranial haematoma	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Ischaemic cerebral infarction	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Ischaemic neuropathy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0013 events2 affected4,943 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG00022 events18 affected4,949 at risk EG00115 events14 affected4,943 at risk
Lacunar infarction	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0013 events3 affected4,943 at risk
Lacunar stroke	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0010 events0 affected4,943 at risk
Language disorder	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Loss of consciousness	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0013 events3 affected4,943 at risk
Lumbar radiculopathy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected4,949 at risk EG0012 events2 affected4,943 at risk
Lumbosacral radiculopathy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0012 events2 affected4,943 at risk
Metabolic encephalopathy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0015 events5 affected4,943 at risk
Migraine	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0013 events2 affected4,943 at risk
Mixed dementia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Monoparesis	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Motor neurone disease	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Myasthenia gravis	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0010 events0 affected4,943 at risk
Myelopathy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0012 events2 affected4,943 at risk
Myoclonus	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Nerve root compression	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Nervous system disorder	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Neuritis	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0015 events5 affected4,943 at risk
Normal pressure hydrocephalus	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0012 events2 affected4,943 at risk
Optic neuritis	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Paralysis recurrent laryngeal nerve	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Parkinson's disease	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0011 events1 affected4,943 at risk
Parkinsonism	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Partial seizures	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0013 events2 affected4,943 at risk
Peripheral nerve paresis	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Peripheral sensorimotor neuropathy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Peroneal nerve palsy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected4,949 at risk EG0011 events1 affected4,943 at risk
Piriformis syndrome	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Polyneuropathy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Post herpetic neuralgia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0010 events0 affected4,943 at risk
Presyncope	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0014 events4 affected4,943 at risk
Pseudobulbar palsy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Psychomotor hyperactivity	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Quadriplegia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0013 events3 affected4,943 at risk
Radiculopathy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0011 events1 affected4,943 at risk
Sciatica	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0008 events7 affected4,949 at risk EG0016 events6 affected4,943 at risk
Seizure	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected4,949 at risk EG0017 events7 affected4,943 at risk
Sensory disturbance	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Serotonin syndrome	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Spinal claudication	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Syncope	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG00034 events33 affected4,949 at risk EG00138 events36 affected4,943 at risk
Thrombotic stroke	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Toxic encephalopathy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Transient global amnesia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0012 events2 affected4,943 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG00024 events23 affected4,949 at risk EG00125 events22 affected4,943 at risk
Tremor	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Trigeminal neuralgia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0012 events1 affected4,943 at risk
Uraemic encephalopathy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Vascular dementia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected4,949 at risk EG0011 events1 affected4,943 at risk
Vascular encephalopathy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0010 events0 affected4,943 at risk
Vascular parkinsonism	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Vertebrobasilar insufficiency	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0012 events2 affected4,943 at risk
Vith nerve paralysis	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Wernicke's encephalopathy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Device damage	Product Issues	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Device dislocation	Product Issues	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected4,949 at risk EG0010 events0 affected4,943 at risk
Device failure	Product Issues	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected4,949 at risk EG0011 events1 affected4,943 at risk
Device loosening	Product Issues	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Device malfunction	Product Issues	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0012 events2 affected4,943 at risk
Device occlusion	Product Issues	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Abnormal behaviour	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Adjustment disorder	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Adjustment disorder with depressed mood	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Affective disorder	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Aggression	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Alcohol abuse	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Alcohol withdrawal syndrome	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Anxiety	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0011 events1 affected4,943 at risk
Anxiety disorder	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Bipolar disorder	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Confusional state	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0007 events7 affected4,949 at risk EG0019 events9 affected4,943 at risk
Delirium	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG00010 events8 affected4,949 at risk EG00110 events10 affected4,943 at risk
Delusion	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Depression	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0008 events7 affected4,949 at risk EG0016 events6 affected4,943 at risk
Depression suicidal	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Disorientation	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0010 events0 affected4,943 at risk
Emotional distress	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Generalised anxiety disorder	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Hypomania	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Major depression	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0013 events3 affected4,943 at risk
Mania	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Mental disorder	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0010 events0 affected4,943 at risk
Mental status changes	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Panic disorder	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Personality change due to a general medical condition	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Psychogenic seizure	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Psychotic disorder	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Restlessness	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Somatic delusion	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Somatic symptom disorder	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Suicidal ideation	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Suicide attempt	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG00074 events67 affected4,949 at risk EG00172 events61 affected4,943 at risk
Atonic urinary bladder	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Azotaemia	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0012 events2 affected4,943 at risk
Bladder dysfunction	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0010 events0 affected4,943 at risk
Bladder fibrosis	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Bladder hypertrophy	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Bladder mass	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Bladder neck obstruction	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0012 events1 affected4,943 at risk
Bladder neck sclerosis	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Bladder obstruction	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Bladder outlet obstruction	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Bladder pain	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Calculus bladder	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0015 events5 affected4,943 at risk
Calculus urethral	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Calculus urinary	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG00020 events19 affected4,949 at risk EG00113 events13 affected4,943 at risk
Cystitis haemorrhagic	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Diabetic nephropathy	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected4,949 at risk EG0013 events3 affected4,943 at risk
Dysuria	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
End stage renal disease	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0006 events6 affected4,949 at risk EG0013 events3 affected4,943 at risk
Haematuria	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0008 events7 affected4,949 at risk EG0012 events2 affected4,943 at risk
Haemorrhage urinary tract	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected4,949 at risk EG0010 events0 affected4,943 at risk
Hydroureter	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Hypertensive nephropathy	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Hypertonic bladder	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Kidney perforation	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG00018 events17 affected4,949 at risk EG00119 events18 affected4,943 at risk
Nephropathy	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0010 events0 affected4,943 at risk
Pelvi-ureteric obstruction	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Proteinuria	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0010 events0 affected4,943 at risk
Renal colic	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0007 events6 affected4,949 at risk EG0018 events7 affected4,943 at risk
Renal cyst	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Renal failure	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG00017 events17 affected4,949 at risk EG00116 events16 affected4,943 at risk
Renal haematoma	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Renal haemorrhage	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0012 events1 affected4,943 at risk
Renal impairment	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0006 events6 affected4,949 at risk EG0018 events7 affected4,943 at risk
Renal infarct	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Renal mass	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0011 events1 affected4,943 at risk
Stress urinary incontinence	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0012 events2 affected4,943 at risk
Tubulointerstitial nephritis	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Ureteric dilatation	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Ureteric stenosis	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Ureterolithiasis	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG00010 events9 affected4,949 at risk EG0019 events9 affected4,943 at risk
Urethral caruncle	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Urethral disorder	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Urethral stenosis	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected4,949 at risk EG0015 events4 affected4,943 at risk
Urinary bladder polyp	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected4,949 at risk EG0011 events1 affected4,943 at risk
Urinary retention	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0009 events9 affected4,949 at risk EG0013 events3 affected4,943 at risk
Urinary tract obstruction	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Acquired phimosis	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG00020 events18 affected2,667 at risk EG00121 events21 affected2,640 at risk
Breast pain	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Cervical polyp	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected2,282 at risk EG0012 events2 affected2,303 at risk
Cystocele	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0005 events4 affected2,282 at risk EG0014 events3 affected2,303 at risk
Endometrial hyperplasia	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected2,282 at risk EG0011 events1 affected2,303 at risk
Endometrial hypertrophy	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected2,282 at risk EG0011 events1 affected2,303 at risk
Endometriosis	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected2,282 at risk EG0011 events1 affected2,303 at risk
Erectile dysfunction	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected2,667 at risk EG0010 events0 affected2,640 at risk
Female genital tract fistula	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected2,282 at risk EG0013 events2 affected2,303 at risk
Fibrocystic breast disease	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0010 events0 affected4,943 at risk
Genital prolapse	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0013 events3 affected4,943 at risk
Gynaecomastia	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected2,667 at risk EG0013 events2 affected2,640 at risk
Metrorrhagia	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected2,282 at risk EG0012 events2 affected2,303 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected2,282 at risk EG0016 events6 affected2,303 at risk
Pelvic fluid collection	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Pelvic prolapse	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Prostatism	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected2,667 at risk EG0010 events0 affected2,640 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected2,667 at risk EG0014 events4 affected2,640 at risk
Prostatomegaly	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected2,667 at risk EG0010 events0 affected2,640 at risk
Rectocele	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected2,282 at risk EG0011 events1 affected2,303 at risk
Uterine disorder	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected2,282 at risk EG0011 events1 affected2,303 at risk
Uterine polyp	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected2,282 at risk EG0013 events3 affected2,303 at risk
Uterine prolapse	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected2,282 at risk EG0013 events3 affected2,303 at risk
Uterovaginal prolapse	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected2,282 at risk EG0012 events2 affected2,303 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected2,282 at risk EG0011 events1 affected2,303 at risk
Vaginal polyp	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected2,282 at risk EG0010 events0 affected2,303 at risk
Vaginal prolapse	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected2,282 at risk EG0012 events2 affected2,303 at risk
Acquired diaphragmatic eventration	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0015 events4 affected4,943 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG00017 events17 affected4,949 at risk EG0017 events6 affected4,943 at risk
Alveolitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Asphyxia	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0010 events0 affected4,943 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG00013 events8 affected4,949 at risk EG0018 events8 affected4,943 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Bronchial hyperreactivity	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Bronchial polyp	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Bronchitis chronic	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0011 events1 affected4,943 at risk
Bronchopneumopathy	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG00045 events35 affected4,949 at risk EG00132 events25 affected4,943 at risk
Chronic respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0011 events1 affected4,943 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0012 events2 affected4,943 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG00015 events15 affected4,949 at risk EG00112 events11 affected4,943 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0006 events6 affected4,949 at risk EG0011 events1 affected4,943 at risk
Emphysema	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected4,949 at risk EG0015 events5 affected4,943 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0011 events1 affected4,943 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Hypercapnia	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Hyperventilation	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0012 events2 affected4,943 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0011 events1 affected4,943 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0007 events7 affected4,949 at risk EG00114 events13 affected4,943 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0011 events1 affected4,943 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Nasal polyps	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Nasal septum deviation	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Obstructive airways disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Pharyngeal haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Pickwickian syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG00010 events8 affected4,949 at risk EG00113 events13 affected4,943 at risk
Pleural thickening	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected4,949 at risk EG0013 events2 affected4,943 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0006 events6 affected4,949 at risk EG0014 events4 affected4,943 at risk
Pneumothorax spontaneous	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0012 events2 affected4,943 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG00022 events21 affected4,949 at risk EG00123 events22 affected4,943 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected4,949 at risk EG0011 events1 affected4,943 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected4,949 at risk EG0013 events3 affected4,943 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0014 events4 affected4,943 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG00020 events20 affected4,949 at risk EG0016 events6 affected4,943 at risk
Pulmonary thrombosis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0014 events3 affected4,943 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0012 events2 affected4,943 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG00022 events20 affected4,949 at risk EG00116 events16 affected4,943 at risk
Respiratory tract oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Restrictive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Rhinitis hypertrophic	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0006 events6 affected4,949 at risk EG0011 events1 affected4,943 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0011 events1 affected4,943 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0010 events0 affected4,943 at risk
Dermatitis atopic	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG00024 events19 affected4,949 at risk EG00117 events14 affected4,943 at risk
Diabetic neuropathic ulcer	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Diabetic ulcer	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0012 events1 affected4,943 at risk
Erythrodermic psoriasis	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Hypersensitivity vasculitis	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0010 events0 affected4,943 at risk
Ischaemic skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Neuropathic ulcer	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0012 events1 affected4,943 at risk
Pemphigoid	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Pyoderma gangrenosum	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Rash generalised	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Rash papular	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Skin disorder	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG00016 events15 affected4,949 at risk EG00113 events9 affected4,943 at risk
Stasis dermatitis	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Subcutaneous emphysema	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Vasculitic ulcer	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Diet noncompliance	Social circumstances	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Organ donor	Social circumstances	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Angiodysplasia	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Aortic aneurysm	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG00110 events10 affected4,943 at risk
Aortic aneurysm rupture	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Aortic arteriosclerosis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Aortic dissection	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0012 events2 affected4,943 at risk
Aortic stenosis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG00017 events16 affected4,949 at risk EG00121 events21 affected4,943 at risk
Arterial occlusive disease	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0004 events3 affected4,949 at risk EG0010 events0 affected4,943 at risk
Arterial stenosis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Arteriosclerosis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Bleeding varicose vein	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Circulatory collapse	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0006 events6 affected4,949 at risk EG0014 events4 affected4,943 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG00010 events10 affected4,949 at risk EG00116 events16 affected4,943 at risk
Dry gangrene	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0013 events3 affected4,943 at risk
Essential hypertension	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Extremity necrosis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0004 events3 affected4,949 at risk EG0013 events3 affected4,943 at risk
Haematoma	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0014 events4 affected4,943 at risk
Haemodynamic instability	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Haemorrhage	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Hypertension	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG00029 events27 affected4,949 at risk EG00124 events22 affected4,943 at risk
Hypertensive crisis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG00021 events21 affected4,949 at risk EG00114 events14 affected4,943 at risk
Hypertensive emergency	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0014 events4 affected4,943 at risk
Hypotension	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0007 events7 affected4,949 at risk EG0011 events1 affected4,943 at risk
Hypovolaemic shock	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Iliac artery embolism	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Intermittent claudication	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected4,949 at risk EG0011 events1 affected4,943 at risk
Lymphatic fistula	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Lymphoedema	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0010 events0 affected4,943 at risk
Neurogenic shock	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected4,949 at risk EG0016 events6 affected4,943 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG00026 events25 affected4,949 at risk EG00118 events17 affected4,943 at risk
Peripheral artery occlusion	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected4,949 at risk EG0019 events8 affected4,943 at risk
Peripheral artery stenosis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4,949 at risk EG0012 events2 affected4,943 at risk
Peripheral artery thrombosis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Peripheral embolism	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0009 events8 affected4,949 at risk EG00113 events9 affected4,943 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0008 events7 affected4,949 at risk EG0018 events8 affected4,943 at risk
Peripheral venous disease	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0011 events1 affected4,943 at risk
Phlebitis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0013 events3 affected4,943 at risk
Shock	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Shock haemorrhagic	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Subclavian artery stenosis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Superior vena cava syndrome	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4,949 at risk EG0011 events1 affected4,943 at risk
Temporal arteritis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Thrombophlebitis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0010 events0 affected4,943 at risk
Thrombosis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0012 events2 affected4,943 at risk
Varicose vein	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected4,949 at risk EG0013 events3 affected4,943 at risk
Vena cava thrombosis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0010 events0 affected4,943 at risk
Venous thrombosis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4,949 at risk EG0010 events0 affected4,943 at risk
Venous thrombosis limb	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4,949 at risk EG0012 events2 affected4,943 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cataract	Eye disorders	MedDRA 21.0	Systematic Assessment	EG000417 events368 affected4,949 at risk EG001427 events363 affected4,943 at risk
Constipation	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG000223 events208 affected4,949 at risk EG001409 events361 affected4,943 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG000546 events436 affected4,949 at risk EG001843 events665 affected4,943 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG000150 events147 affected4,949 at risk EG001331 events291 affected4,943 at risk
Nausea	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG000310 events269 affected4,949 at risk EG001968 events735 affected4,943 at risk
Vomiting	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG000165 events154 affected4,949 at risk EG001498 events325 affected4,943 at risk
Bronchitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG000554 events421 affected4,949 at risk EG001528 events408 affected4,943 at risk
Influenza	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG000488 events404 affected4,949 at risk EG001435 events369 affected4,943 at risk
Nasopharyngitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG000771 events535 affected4,949 at risk EG001800 events564 affected4,943 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG000589 events407 affected4,949 at risk EG001533 events368 affected4,943 at risk
Urinary tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG000749 events517 affected4,949 at risk EG001795 events545 affected4,943 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG000109 events104 affected4,949 at risk EG001379 events325 affected4,943 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG000445 events315 affected4,949 at risk EG001190 events158 affected4,943 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001,160 events354 affected4,949 at risk EG0011,477 events413 affected4,943 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG000469 events389 affected4,949 at risk EG001446 events371 affected4,943 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG000484 events416 affected4,949 at risk EG001494 events447 affected4,943 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG000373 events318 affected4,949 at risk EG001372 events329 affected4,943 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG000280 events245 affected4,949 at risk EG001296 events260 affected4,943 at risk
Dizziness	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG000339 events296 affected4,949 at risk EG001373 events318 affected4,943 at risk
Headache	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG000382 events288 affected4,949 at risk EG001414 events324 affected4,943 at risk
Microalbuminuria	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG000263 events259 affected4,949 at risk EG001241 events232 affected4,943 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG000137 events135 affected2,667 at risk EG001144 events140 affected2,640 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG000292 events256 affected4,949 at risk EG001265 events239 affected4,943 at risk
Hypertension	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG000491 events432 affected4,949 at risk EG001405 events345 affected4,943 at risk

ID	Term
D002318	Cardiovascular Diseases
D003924	Diabetes Mellitus, Type 2
D003920	Diabetes Mellitus

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Title	Description
BG000	Placebo	Placebo was administered once weekly, subcutaneously
BG001	Dulaglutide	1.5 mg Dulaglutide was administered once weekly, subcutaneously
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Placebo was administered once weekly, subcutaneously	592	4,949	2,044	4,949	3,363	4,949
EG001	Dulaglutide	1.5 mg Dulaglutide was administered once weekly, subcutaneously	536	4,943	1,991	4,943	3,574	4,943