BI 10773 (Empagliflozin) Cardiovascular Outcome Event Tri... | NCT01131676

NCT01131676

ID	Type	Description	Link
2009-016178-33	EudraCT Number	EudraCT

Status Module

Name	Class
Eli Lilly and Company	INDUSTRY

Label	Type	Description	Intervention Names
BI 10773 low dose	Experimental	BI 10773 tablets once daily	Drug: BI 10773 low dose Drug: Placebo BI 10773 high dose
BI 10773 high dose	Experimental	BI 10773 tablets once daily	Drug: BI 10773 high dose Drug: Placebo BI 10773 low dose
Placebo	Placebo Comparator	Placebo tablets matching BI 10773	Drug: Placebo BI 10773 high dose Drug: Placebo BI 10773 low dose

Name	Type	Description	Arm Group Labels	Other Names
BI 10773 low dose	Drug	BI 10773 tablets once daily	BI 10773 low dose

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to the First Occurrence of Any of the Following Adjudicated Components of the Primary Composite Endpoint (3-point MACE): CV Death (Including Fatal Stroke and Fatal MI), Non-fatal MI (Excluding Silent MI), and Non-fatal Stroke.	Time to the first occurrence of any of the following adjudicated components of the primary composite endpoint (3-point major adverse cardiovascular events (MACE)): cardiovascular (CV) death (including fatal stroke and fatal myocardial infarction (MI)), non-fatal MI (excluding silent MI), and non-fatal stroke. Percentage of patients with the event are presented.	From randomisation to individual end of observation, up to 4.6 years

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With the Composite of All Events Adjudicated (4-point MACE): CV Death (Including Fatal Stroke and Fatal MI), Non-fatal MI (Excluding Silent MI), Non-fatal Stroke and Hospitalization for Unstable Angina Pectoris	The composite of all events adjudicated (4-point MACE): cardiovascular death (including fatal stroke and fatal myocardial infarction), non-fatal myocardial infarction (excluding silent MI), non-fatal stroke and hospitalization for unstable angina pectoris.This is a key secondary endpoint of the trial. Percentage of patients with the event are presented.

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Diagnosis of type 2 diabetes mellitus prior to informed consent
Male or female patients on diet and exercise regimen who are drug naive or pre treated with any background therapy. Antidiabetic therapy has to be unchanged for 12 weeks prior to randomization.
Glycosylated haemoglobin (HbA1c) of >= 7.0% and <=10% for patients on background therapy or HbA1c >= 7.0% and <= 9.0% for drug naive patients
Age >= 18 years
Body Mass index <= 45 at Visit 1
Signed and dated informed consent
High cardiovascular risk

Exclusion criteria:

Uncontrolled hyperglycaemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in and confirmed by a second measurement (not on the same day)
Indication of liver disease, defined by serum levels of either alanine aminotransferase (ALT), aspartate aminotransferase ALT or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined at screening and/or run in.
Planned cardiac surgery or angioplasty within 3 months
Impaired renal function, defined as Glomerular Filtration Rate <30 ml/min (severe renal impairment, Modification of Diet in Renal Disease formula) during screening or run in.
Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption
Blood dyscrasias or any disorders causing haemolysis or unstable Red Blood Cell (e.g. malaria, babesiosis, haemolytic anemia)
Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years
Contraindications to background therapy according to the local label
Treatment with anti-obesity drugs (e.g. sibutramine, orlistat) 3 months prior to informed consent or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen, etc.) leading to unstable body weight
Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except type 2 diabetes mellitus
Pre-menopausal women (last menstruation <+ 1 year prior to informed consent) who:
- are nursing or pregnant or
- are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems, oral, implantable or injectable contraceptives, sexual abstinence, double barrier method and vasectomised partner
Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake
Participation in another trial with an investigational drug within 30 days prior to informed consent
Any other clinical condition that would jeopardize patients safety while participating in this clinical trial
Acute coronary syndrome, stroke or TIA within 2 months prior to informed consent

Name	Affiliation	Role
Boehringer Ingelheim	Boehringer Ingelheim	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
1245.25.10043 Boehringer Ingelheim Investigational Site		Birmingham	Alabama		United States
1245.25.10121 Boehringer Ingelheim Investigational Site

PubMed Identifier	Type	Citation	Retractions
39026628	Derived	Odutayo A, Zinman B, Wanner C, Zwiener I, Lund SS, Hantel S, Fitchett D, Udell JA; EMPA-REG OUTCOME Trial Investigators. Effect of Qualifying Atherosclerotic Cardiovascular Disease Diagnosis Proximity on Cardiovascular Risk and Benefit of Empagliflozin in the EMPA-REG OUTCOME Trial. CJC Open. 2024 Feb 9;6(7):868-875. doi: 10.1016/j.cjco.2024.01.013. eCollection 2024 Jul.
38992713

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo	Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily)
FG001	Empagliflozin 10 mg	Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily)

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

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

Time to the First Occurrence of Any of the Following Adjudicated Components of the Primary Composite Endpoint (3-point MACE): CV Death (Including Fatal Stroke and Fatal MI), Non-fatal MI (Excluding Silent MI), and Non-fatal Stroke.

Time to the first occurrence of any of the following adjudicated components of the primary composite endpoint (3-point major adverse cardiovascular events (MACE)): cardiovascular (CV) death (including fatal stroke and fatal myocardial infarction (MI)), non-fatal MI (excluding silent MI), and non-fatal stroke.

Percentage of patients with the event are presented.

Posted

Number

percentage of participants

From randomisation to individual end of observation, up to 4.6 years

ID	Title	Description
OG000	Placebo	Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily)
OG001	Empagliflozin 10 mg	Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily)
OG002	Empagliflozin 25 mg	Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily)
OG003	All Empagliflozin	Patients who received either 10 mg or 25 mg of empagliflozin were pooled into a common empagliflozin treatment group

Units	Counts
Participants	OG0002333 OG0012345 OG0022342 OG003

Title

Denominators

Categories

Title	Measurements
	OG00012.1 OG00110.4 OG00210.5 OG003

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 OG003	Primary objective was to establish the non-inferiority of All empagliflozin relative to placebo for time to first 3-point MACE. A 4-step hierarchical testing strategy was followed for the non-inferiority test of the primary endpoint and then the key secondary endpoint, each at a margin of 1.3, followed by test of superiority of primary and key secondary endpoints.	Cox proportional hazards model	Cox proportional hazards model with factors for treatment, age, gender, categorised BMI, HbA1c, eGFR and geographical region.	<0.0001	One-sided test with alpha = 0.0249	Hazard Ratio (HR)	0.86			2-Sided	95.02	0.74	0.99			All Empagliflozin divided by Placebo

Secondary

Percentage of Participants With the Composite of All Events Adjudicated (4-point MACE): CV Death (Including Fatal Stroke and Fatal MI), Non-fatal MI (Excluding Silent MI), Non-fatal Stroke and Hospitalization for Unstable Angina Pectoris

The composite of all events adjudicated (4-point MACE): cardiovascular death (including fatal stroke and fatal myocardial infarction), non-fatal myocardial infarction (excluding silent MI), non-fatal stroke and hospitalization for unstable angina pectoris.This is a key secondary endpoint of the trial.

Percentage of patients with the event are presented.

Posted

Number

percentage of participants

From randomisation to individual end of observation, up to 4.6 years

ID	Title	Description
OG000	Placebo	Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily)
OG001	Empagliflozin 10 mg	Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily)
OG002	Empagliflozin 25 mg	Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily)
OG003

Secondary

Percentage of Participants With Silent MI

Silent MI; defined as presence in the ECG of:

Any Q-wave in leads V2-V3 ≥0.02 seconds or QS complex in leads V2 and V3
Q-wave ≥0.03 seconds and ≥0.1 mV deep or QS complex in leads I, II, aVL, aVF, or V4-V6 in any two leads of a contiguous lead grouping (I, aVL, V6; V4-V6; II, III, and aVF)
R-wave ≥0.04 seconds in V1-V2 and R/S ≥1 with a concordant positive T-wave in the absence of a conduction defect.

It was also required that there had been no adjudicated and confirmed event of either acute MI, hospitalisation for unstable angina, coronary revascularisation procedures or stent thrombosis following randomisation up to and including the date of the specified ECG measurement.

Percentage of patients with the event are presented.

TS (evaluable cases)

Posted

Number

percentage of participants

From randomisation to individual end of observation, up to 4.6 years

ID	Title	Description
OG000	Placebo	Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily)
OG001	Empagliflozin 10 mg	Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily)
OG002	Empagliflozin 25 mg

Secondary

Percentage of Participants With Heart Failure Requiring Hospitalisation (Adjudicated)

Heart failure requiring hospitalisation (adjudicated). Percentage of patients with the event are presented.

Posted

Number

percentage of participants

From randomisation to individual end of observation, up to 4.6 years

ID	Title	Description
OG000	Placebo	Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily)
OG001	Empagliflozin 10 mg	Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily)
OG002	Empagliflozin 25 mg	Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily)
OG003	All Empagliflozin	Patients who received either 10 mg or 25 mg of empagliflozin were pooled into a common empagliflozin treatment group

Secondary

Percentage of Participants With New Onset Albuminuria

New onset albuminuria defined as urine albumin / creatinine ratio (UACR) ≥30 mg/g.

Percentage of patients with the event are presented.

TS (evaluable cases)

Posted

Number

percentage of participants

From randomisation to individual end of observation, up to 4.6 years

ID	Title	Description
OG000	Placebo	Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily)
OG001	Empagliflozin 10 mg	Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily)
OG002	Empagliflozin 25 mg	Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily)
OG003	All Empagliflozin	Patients who received either 10 mg or 25 mg of empagliflozin were pooled into a common empagliflozin treatment group

Secondary

Percentage of Participants With New Onset Macroalbuminuria

New onset macroalbuminuria defined as UACR >300 mg/g. Percentage of patients with the event are presented.

TS (evaluable cases)

Posted

Number

percentage of participants

From randomisation to individual end of observation, up to 4.6 years

ID	Title	Description
OG000	Placebo	Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily)
OG001	Empagliflozin 10 mg	Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily)
OG002	Empagliflozin 25 mg	Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily)
OG003	All Empagliflozin	Patients who received either 10 mg or 25 mg of empagliflozin were pooled into a common empagliflozin treatment group

Secondary

Percentage of Participants With the Composite Microvascular Outcome

Composite microvascular outcome defined as:

Initiation of retinal photocoagulation
Vitreous haemorrhage
Diabetes-related blindness, or
New or worsening nephropathy defined as:
- New onset of macroalbuminuria; or
- Doubling of serum creatinine level accompanied by an eGFR (based on modification of diet in renal disease (MDRD) formula) ≤45 mL/min/1.73m2; or
- Initiation of continuous renal replacement therapy, or
- Death due to renal disease. Percentage of patients with the event are presented.

TS (evaluable cases)

Posted

Number

percentage of participants

From randomisation to individual end of observation, up to 4.6 years

ID	Title	Description
OG000	Placebo	Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily)
OG001	Empagliflozin 10 mg	Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily)
OG002	Empagliflozin 25 mg	Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily)

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG00012 affected2,333 at risk EG0018 affected2,345 at risk EG0027 affected2,342 at risk
Coagulopathy	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0021 affected2,342 at risk
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0022 affected2,342 at risk
Hypereosinophilic syndrome	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Hypochromic anaemia	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Hypocoagulable state	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0011 affected2,345 at risk EG0024 affected2,342 at risk
Microcytic anaemia	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0012 affected2,345 at risk EG0020 affected2,342 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Normochromic normocytic anaemia	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG00010 affected2,333 at risk EG00110 affected2,345 at risk EG00214 affected2,342 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG00042 affected2,333 at risk EG00132 affected2,345 at risk EG00248 affected2,342 at risk
Angina pectoris	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG00032 affected2,333 at risk EG00136 affected2,345 at risk EG00242 affected2,342 at risk
Angina unstable	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG00087 affected2,333 at risk EG00182 affected2,345 at risk EG00273 affected2,342 at risk
Aortic valve disease	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0022 affected2,342 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0022 affected2,342 at risk
Arrhythmia	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0015 affected2,345 at risk EG0021 affected2,342 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0011 affected2,345 at risk EG0026 affected2,342 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG00014 affected2,333 at risk EG00125 affected2,345 at risk EG00212 affected2,342 at risk
Atrial flutter	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0005 affected2,333 at risk EG0017 affected2,345 at risk EG0024 affected2,342 at risk
Atrial tachycardia	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Atrial thrombosis	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Atrioventricular block	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected2,333 at risk EG0012 affected2,345 at risk EG0021 affected2,342 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0012 affected2,345 at risk EG0023 affected2,342 at risk
Atrioventricular block first degree	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0011 affected2,345 at risk EG0021 affected2,342 at risk
Atrioventricular block second degree	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0012 affected2,345 at risk EG0021 affected2,342 at risk
Bradyarrhythmia	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Bradycardia	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG00011 affected2,333 at risk EG0012 affected2,345 at risk EG0024 affected2,342 at risk
Bundle branch block bilateral	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Bundle branch block right	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Cardiac arrest	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG00012 affected2,333 at risk EG0016 affected2,345 at risk EG0025 affected2,342 at risk
Cardiac asthma	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Cardiac disorder	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Cardiac failure	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG00055 affected2,333 at risk EG00142 affected2,345 at risk EG00224 affected2,342 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0009 affected2,333 at risk EG0014 affected2,345 at risk EG0022 affected2,342 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0014 affected2,345 at risk EG0022 affected2,342 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG00045 affected2,333 at risk EG00130 affected2,345 at risk EG00235 affected2,342 at risk
Cardiac failure high output	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0006 affected2,333 at risk EG0015 affected2,345 at risk EG0022 affected2,342 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0012 affected2,345 at risk EG0022 affected2,342 at risk
Cardiomyopathy	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Cardiorenal syndrome	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Cardiovascular disorder	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Cardiovascular insufficiency	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Congestive cardiomyopathy	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Coronary artery disease	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG00046 affected2,333 at risk EG00121 affected2,345 at risk EG00229 affected2,342 at risk
Coronary artery insufficiency	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0006 affected2,333 at risk EG0013 affected2,345 at risk EG0027 affected2,342 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0005 affected2,333 at risk EG0015 affected2,345 at risk EG0025 affected2,342 at risk
Cyanosis	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Diastolic dysfunction	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Hypertensive cardiomyopathy	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Hypertensive heart disease	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Intracardiac thrombus	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0024 affected2,342 at risk
Left atrial dilatation	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0021 affected2,342 at risk
Left ventricular dysfunction	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0022 affected2,342 at risk
Left ventricular failure	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Microvascular coronary artery disease	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Myocardial infarction	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG00047 affected2,333 at risk EG00150 affected2,345 at risk EG00244 affected2,342 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG00015 affected2,333 at risk EG0015 affected2,345 at risk EG0027 affected2,342 at risk
Myocarditis	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Nodal arrhythmia	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Palpitations	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0012 affected2,345 at risk EG0021 affected2,342 at risk
Papillary muscle disorder	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Pericardial cyst	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Pericardial effusion	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0012 affected2,345 at risk EG0020 affected2,342 at risk
Pericarditis	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Postinfarction angina	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Right ventricular failure	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Silent myocardial infarction	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0013 affected2,345 at risk EG0023 affected2,342 at risk
Sinus arrhythmia	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Sinus bradycardia	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0011 affected2,345 at risk EG0022 affected2,342 at risk
Sinus node dysfunction	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0006 affected2,333 at risk EG0015 affected2,345 at risk EG0023 affected2,342 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0004 affected2,333 at risk EG0015 affected2,345 at risk EG0021 affected2,342 at risk
Systolic dysfunction	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Tachycardia	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0005 affected2,333 at risk EG0013 affected2,345 at risk EG0020 affected2,342 at risk
Tachycardia paroxysmal	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Trifascicular block	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Ventricular arrhythmia	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0011 affected2,345 at risk EG0022 affected2,342 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0008 affected2,333 at risk EG0012 affected2,345 at risk EG0025 affected2,342 at risk
Atrial septal defect	Congenital, familial and genetic disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Congenital anomalies of ear ossicles	Congenital, familial and genetic disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Hydrocele	Congenital, familial and genetic disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Phimosis	Congenital, familial and genetic disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0011 affected2,345 at risk EG0022 affected2,342 at risk
Pyloric stenosis	Congenital, familial and genetic disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Cerumen impaction	Ear and labyrinth disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Deafness	Ear and labyrinth disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Deafness unilateral	Ear and labyrinth disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Sudden hearing loss	Ear and labyrinth disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Tympanic membrane perforation	Ear and labyrinth disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 18.0	Systematic Assessment	EG0007 affected2,333 at risk EG0012 affected2,345 at risk EG0029 affected2,342 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA 18.0	Systematic Assessment	EG0006 affected2,333 at risk EG0010 affected2,345 at risk EG0022 affected2,342 at risk
Basedow's disease	Endocrine disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Goitre	Endocrine disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0022 affected2,342 at risk
Hyperparathyroidism	Endocrine disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0022 affected2,342 at risk
Hyperparathyroidism primary	Endocrine disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Amaurosis	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Blindness	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Blindness unilateral	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Cataract	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0009 affected2,333 at risk EG00113 affected2,345 at risk EG00211 affected2,342 at risk
Cataract cortical	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Corneal degeneration	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Diabetic retinopathy	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0004 affected2,333 at risk EG0011 affected2,345 at risk EG0022 affected2,342 at risk
Exfoliation syndrome	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Glaucoma	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0013 affected2,345 at risk EG0022 affected2,342 at risk
Keratopathy	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Macular fibrosis	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Macular oedema	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Papilloedema	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Retinal artery occlusion	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0022 affected2,342 at risk
Retinal detachment	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0014 affected2,345 at risk EG0022 affected2,342 at risk
Retinal haemorrhage	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Retinal tear	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Retinopathy	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Retinoschisis	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Visual acuity reduced	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Vitreous haemorrhage	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0004 affected2,333 at risk EG0011 affected2,345 at risk EG0023 affected2,342 at risk
Vitreous opacities	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0013 affected2,345 at risk EG0020 affected2,342 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0012 affected2,345 at risk EG0022 affected2,342 at risk
Abdominal hernia obstructive	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0005 affected2,333 at risk EG0015 affected2,345 at risk EG0022 affected2,342 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0013 affected2,345 at risk EG0022 affected2,342 at risk
Anal fissure	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Anal fistula	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0012 affected2,345 at risk EG0020 affected2,342 at risk
Ascites	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0012 affected2,345 at risk EG0020 affected2,342 at risk
Bezoar	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Chronic gastritis	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Colitis	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0012 affected2,345 at risk EG0023 affected2,342 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Colon dysplasia	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Constipation	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0004 affected2,333 at risk EG0012 affected2,345 at risk EG0022 affected2,342 at risk
Crohn's disease	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Dental caries	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Diabetic gastroparesis	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Diabetic gastropathy	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0006 affected2,333 at risk EG0016 affected2,345 at risk EG0024 affected2,342 at risk
Diverticulum	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0011 affected2,345 at risk EG0021 affected2,342 at risk
Diverticulum intestinal	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0013 affected2,345 at risk EG0021 affected2,342 at risk
Duodenal perforation	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0012 affected2,345 at risk EG0020 affected2,342 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Duodenal ulcer perforation	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Duodenitis	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0011 affected2,345 at risk EG0021 affected2,342 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Enteritis	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Epigastric discomfort	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Erosive duodenitis	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Faecaloma	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Food poisoning	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0022 affected2,342 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Gastric perforation	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Gastric polyps	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected2,333 at risk EG0011 affected2,345 at risk EG0022 affected2,342 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Gastric ulcer perforation	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Gastritis	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0012 affected2,345 at risk EG0027 affected2,342 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0011 affected2,345 at risk EG0021 affected2,342 at risk
Gastritis haemorrhagic	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Gastroduodenal ulcer	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Gastroduodenitis	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Gastrointestinal angiodysplasia	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0009 affected2,333 at risk EG0014 affected2,345 at risk EG0024 affected2,342 at risk
Gastrointestinal inflammation	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0005 affected2,333 at risk EG0017 affected2,345 at risk EG0023 affected2,342 at risk
Gingival bleeding	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0012 affected2,345 at risk EG0020 affected2,342 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0011 affected2,345 at risk EG0021 affected2,342 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected2,333 at risk EG0012 affected2,345 at risk EG0021 affected2,342 at risk
Haemorrhoids thrombosed	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Ileus	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0021 affected2,342 at risk
Ileus paralytic	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Impaired gastric emptying	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0023 affected2,342 at risk
Incarcerated umbilical hernia	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected2,333 at risk EG0015 affected2,345 at risk EG0024 affected2,342 at risk
Inguinal hernia strangulated	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0021 affected2,342 at risk
Intestinal haemorrhage	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Intestinal ischaemia	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0012 affected2,345 at risk EG0020 affected2,342 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0005 affected2,333 at risk EG0011 affected2,345 at risk EG0023 affected2,342 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Irritable bowel syndrome	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Large intestinal ulcer	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0015 affected2,345 at risk EG0020 affected2,342 at risk
Localised intraabdominal fluid collection	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Lumbar hernia	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Mallory-Weiss syndrome	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0011 affected2,345 at risk EG0021 affected2,342 at risk
Melaena	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0021 affected2,342 at risk
Mesenteric vein thrombosis	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Nausea	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0014 affected2,345 at risk EG0022 affected2,342 at risk
Oesophageal stenosis	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0004 affected2,333 at risk EG0013 affected2,345 at risk EG0023 affected2,342 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected2,333 at risk EG0011 affected2,345 at risk EG0023 affected2,342 at risk
Pancreatitis chronic	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Pancreatitis relapsing	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Peptic ulcer	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0012 affected2,345 at risk EG0020 affected2,342 at risk
Peptic ulcer haemorrhage	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Peptic ulcer perforation	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Peritoneal haemorrhage	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0012 affected2,345 at risk EG0022 affected2,342 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0013 affected2,345 at risk EG0022 affected2,342 at risk
Small intestinal perforation	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Stress ulcer	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Subileus	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Thrombosis mesenteric vessel	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0013 affected2,345 at risk EG0020 affected2,342 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected2,333 at risk EG0012 affected2,345 at risk EG0025 affected2,342 at risk
Varices oesophageal	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Volvulus	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Vomiting	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0013 affected2,345 at risk EG0024 affected2,342 at risk
Adverse drug reaction	General disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Asthenia	General disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0012 affected2,345 at risk EG0021 affected2,342 at risk
Cardiac death	General disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected2,333 at risk EG0014 affected2,345 at risk EG0022 affected2,342 at risk
Chest discomfort	General disorders	MedDRA 18.0	Systematic Assessment	EG0004 affected2,333 at risk EG0012 affected2,345 at risk EG0023 affected2,342 at risk
Chest pain	General disorders	MedDRA 18.0	Systematic Assessment	EG00028 affected2,333 at risk EG00132 affected2,345 at risk EG00233 affected2,342 at risk
Chills	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Death	General disorders	MedDRA 18.0	Systematic Assessment	EG00012 affected2,333 at risk EG00110 affected2,345 at risk EG0025 affected2,342 at risk
Device defective	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Device deposit issue	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Device difficult to use	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Device malfunction	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Device occlusion	General disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0022 affected2,342 at risk
Drowning	General disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Drug ineffective	General disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Dysplasia	General disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Extravasation	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Fatigue	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Feeling abnormal	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Gait disturbance	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0011 affected2,345 at risk EG0021 affected2,342 at risk
General physical health deterioration	General disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Generalised oedema	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Granuloma	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Hernia	General disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Impaired healing	General disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0021 affected2,342 at risk
Implant site necrosis	General disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Malaise	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Multi-organ failure	General disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected2,333 at risk EG0012 affected2,345 at risk EG0020 affected2,342 at risk
Necrobiosis	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Non-cardiac chest pain	General disorders	MedDRA 18.0	Systematic Assessment	EG0006 affected2,333 at risk EG0015 affected2,345 at risk EG00215 affected2,342 at risk
Oedema peripheral	General disorders	MedDRA 18.0	Systematic Assessment	EG0005 affected2,333 at risk EG0011 affected2,345 at risk EG0021 affected2,342 at risk
Oversensing	General disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Pacemaker generated arrhythmia	General disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Pain	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Perforated ulcer	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Peripheral swelling	General disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0011 affected2,345 at risk EG0021 affected2,342 at risk
Polyp	General disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Pyrexia	General disorders	MedDRA 18.0	Systematic Assessment	EG0005 affected2,333 at risk EG0017 affected2,345 at risk EG0022 affected2,342 at risk
Stent malfunction	General disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Strangulated hernia	General disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Sudden cardiac death	General disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0012 affected2,345 at risk EG0022 affected2,342 at risk
Sudden death	General disorders	MedDRA 18.0	Systematic Assessment	EG0006 affected2,333 at risk EG0018 affected2,345 at risk EG0025 affected2,342 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Ulcer	General disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Bile duct obstruction	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0014 affected2,345 at risk EG0022 affected2,342 at risk
Cholangitis	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0004 affected2,333 at risk EG0014 affected2,345 at risk EG0025 affected2,342 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0004 affected2,333 at risk EG0017 affected2,345 at risk EG0026 affected2,342 at risk
Cholecystitis chronic	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0007 affected2,333 at risk EG0019 affected2,345 at risk EG00212 affected2,342 at risk
Cholestasis	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Gallbladder disorder	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0012 affected2,345 at risk EG0022 affected2,342 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Hepatic steatosis	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Ischaemic hepatitis	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Jaundice cholestatic	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Non-alcoholic steatohepatitis	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Portal hypertension	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Post cholecystectomy syndrome	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Sphincter of Oddi dysfunction	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Anaphylactic reaction	Immune system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0021 affected2,342 at risk
Anaphylactic shock	Immune system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0021 affected2,342 at risk
Contrast media allergy	Immune system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Food allergy	Immune system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0022 affected2,342 at risk
Hypersensitivity	Immune system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Iodine allergy	Immune system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Abdominal abscess	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0012 affected2,345 at risk EG0020 affected2,342 at risk
Abdominal wall abscess	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0012 affected2,345 at risk EG0021 affected2,342 at risk
Abscess	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Abscess limb	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0003 affected2,333 at risk EG0016 affected2,345 at risk EG0022 affected2,342 at risk
Abscess of eyelid	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Acute sinusitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0022 affected2,342 at risk
Amoebiasis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Amoebic dysentery	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Anal abscess	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Appendicitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0003 affected2,333 at risk EG0015 affected2,345 at risk EG0023 affected2,342 at risk
Appendicitis perforated	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0022 affected2,342 at risk
Arteriosclerotic gangrene	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Arthritis bacterial	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0011 affected2,345 at risk EG0022 affected2,342 at risk
Atypical pneumonia	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Bacteraemia	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0010 affected2,345 at risk EG0023 affected2,342 at risk
Bacterial sepsis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Biliary tract infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Bone abscess	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Bronchiolitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Bronchitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG00010 affected2,333 at risk EG0015 affected2,345 at risk EG0025 affected2,342 at risk
Bronchitis viral	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Bronchopneumonia	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0003 affected2,333 at risk EG0011 affected2,345 at risk EG0023 affected2,342 at risk
Catheter site infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Cellulitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG00020 affected2,333 at risk EG00111 affected2,345 at risk EG00217 affected2,342 at risk
Cellulitis gangrenous	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0012 affected2,345 at risk EG0020 affected2,342 at risk
Cellulitis of male external genital organ	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Cellulitis staphylococcal	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Cholecystitis infective	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Chronic sinusitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0023 affected2,342 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Cutaneous larva migrans	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Cystitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Cystitis bacterial	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Dengue fever	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0012 affected2,345 at risk EG0021 affected2,342 at risk
Device related infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Device related sepsis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Diabetic foot infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0006 affected2,333 at risk EG0015 affected2,345 at risk EG0027 affected2,342 at risk
Diabetic gangrene	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0003 affected2,333 at risk EG0011 affected2,345 at risk EG0022 affected2,342 at risk
Diverticulitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0003 affected2,333 at risk EG0013 affected2,345 at risk EG0020 affected2,342 at risk
Ear infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Eczema infected	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Empyema	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Endocarditis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Endophthalmitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Enterocolitis infectious	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Enterocolitis viral	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Epididymitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Erysipelas	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0009 affected2,333 at risk EG0018 affected2,345 at risk EG0025 affected2,342 at risk
Escherichia sepsis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Febrile infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Furuncle	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Gallbladder empyema	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Gangrene	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0008 affected2,333 at risk EG00110 affected2,345 at risk EG0026 affected2,342 at risk
Gastroenteritis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG00015 affected2,333 at risk EG00118 affected2,345 at risk EG00215 affected2,342 at risk
Gastroenteritis salmonella	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0021 affected2,342 at risk
Gastrointestinal infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Gastrointestinal protozoal infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Giardiasis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
H1N1 influenza	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0022 affected2,342 at risk
Incision site infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Infected skin ulcer	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0004 affected2,333 at risk EG0012 affected2,345 at risk EG0023 affected2,342 at risk
Infectious colitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Infectious pleural effusion	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Influenza	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Infusion site infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Inguinal hernia gangrenous	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Intestinal fistula infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Intestinal tuberculosis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Kidney infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Klebsiella infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Labyrinthitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Liver abscess	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Lobar pneumonia	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0003 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Localised infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0005 affected2,333 at risk EG0012 affected2,345 at risk EG0024 affected2,342 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0004 affected2,333 at risk EG0018 affected2,345 at risk EG0022 affected2,342 at risk
Lower respiratory tract infection bacterial	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Lung infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0012 affected2,345 at risk EG0020 affected2,342 at risk
Lyme disease	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Mediastinitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Meningitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Meningitis bacterial	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Meningitis streptococcal	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Meningitis tuberculous	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Muscle abscess	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Myelitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Nasal abscess	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Oesophageal candidiasis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Osteomyelitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0005 affected2,333 at risk EG0015 affected2,345 at risk EG0029 affected2,342 at risk
Osteomyelitis acute	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Osteomyelitis bacterial	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Osteomyelitis chronic	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Otitis externa	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Otitis media	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Periodontitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Peritonitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0012 affected2,345 at risk EG0023 affected2,342 at risk
Peritonsillar abscess	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Pertussis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Pharyngotonsillitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Pneumonia	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG00053 affected2,333 at risk EG00141 affected2,345 at risk EG00238 affected2,342 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Pneumonia fungal	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Pneumonia haemophilus	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Pneumonia influenzal	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Pneumonia pneumococcal	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Post procedural infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Post procedural sepsis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Postoperative wound infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0011 affected2,345 at risk EG0022 affected2,342 at risk
Prostatic abscess	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Pseudomonal sepsis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Psoas abscess	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Pulmonary mycosis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Pulmonary tuberculosis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Pyelonephritis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0010 affected2,345 at risk EG0025 affected2,342 at risk
Pyelonephritis acute	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0006 affected2,333 at risk EG0014 affected2,345 at risk EG0021 affected2,342 at risk
Pyelonephritis chronic	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Respiratory tract infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0007 affected2,333 at risk EG0010 affected2,345 at risk EG0022 affected2,342 at risk
Rhinitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Rotavirus infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Salmonellosis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Scrotal abscess	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0021 affected2,342 at risk
Sepsis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0005 affected2,333 at risk EG0017 affected2,345 at risk EG0026 affected2,342 at risk
Septic encephalopathy	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Septic shock	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0008 affected2,333 at risk EG0012 affected2,345 at risk EG0025 affected2,342 at risk
Sinusitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Skin infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Staphylococcal infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0012 affected2,345 at risk EG0020 affected2,342 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Staphylococcal skin infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Subcutaneous abscess	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0022 affected2,342 at risk
Tonsillitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Tracheobronchitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0012 affected2,345 at risk EG0020 affected2,342 at risk
Tuberculosis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Tuberculous pleurisy	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0011 affected2,345 at risk EG0022 affected2,342 at risk
Urinary tract infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG00016 affected2,333 at risk EG00113 affected2,345 at risk EG00216 affected2,342 at risk
Urinary tract infection fungal	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0023 affected2,342 at risk
Urinary tract infection pseudomonal	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Urosepsis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0003 affected2,333 at risk EG0016 affected2,345 at risk EG00211 affected2,342 at risk
Vaginal cellulitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Varicella	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Vestibular neuronitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Viral infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0012 affected2,345 at risk EG0025 affected2,342 at risk
Wound infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0003 affected2,333 at risk EG0014 affected2,345 at risk EG0023 affected2,342 at risk
Wound sepsis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Accident at work	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Acetabulum fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Anaemia postoperative	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Animal bite	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0014 affected2,345 at risk EG0022 affected2,342 at risk
Avulsion fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Back injury	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Brain contusion	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0011 affected2,345 at risk EG0021 affected2,342 at risk
Cardiac procedure complication	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Chemical poisoning	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Chest injury	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0012 affected2,345 at risk EG0022 affected2,342 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0004 affected2,333 at risk EG0012 affected2,345 at risk EG0022 affected2,342 at risk
Coronary artery restenosis	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0004 affected2,333 at risk EG0014 affected2,345 at risk EG0022 affected2,342 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0022 affected2,342 at risk
Deep vein thrombosis postoperative	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG00016 affected2,333 at risk EG0019 affected2,345 at risk EG00216 affected2,342 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0011 affected2,345 at risk EG0022 affected2,342 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0003 affected2,333 at risk EG0010 affected2,345 at risk EG0022 affected2,342 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Fracture displacement	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Gastrointestinal anastomotic complication	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Graft thrombosis	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Gun shot wound	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0011 affected2,345 at risk EG0021 affected2,342 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0011 affected2,345 at risk EG0027 affected2,342 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0012 affected2,345 at risk EG0023 affected2,342 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Injury	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Intentional overdose	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Intestinal anastomosis complication	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0012 affected2,345 at risk EG0020 affected2,342 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Kidney rupture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Ligament rupture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Meniscus injury	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0003 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Multiple fractures	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Multiple injuries	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Muscle injury	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Open fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Periorbital contusion	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Peripheral artery restenosis	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0012 affected2,345 at risk EG0020 affected2,342 at risk
Periprosthetic fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Perirenal haematoma	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Post laminectomy syndrome	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Post procedural discomfort	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Post procedural haematuria	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0013 affected2,345 at risk EG0020 affected2,342 at risk
Postoperative ileus	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Pubis fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0013 affected2,345 at risk EG0020 affected2,342 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0006 affected2,333 at risk EG0014 affected2,345 at risk EG0024 affected2,342 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0006 affected2,333 at risk EG0016 affected2,345 at risk EG0029 affected2,342 at risk
Scar	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0021 affected2,342 at risk
Seroma	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Skin abrasion	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Spinal column injury	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0023 affected2,342 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Splenic rupture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Stab wound	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0012 affected2,345 at risk EG0021 affected2,342 at risk
Subdural haemorrhage	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Tendon injury	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0007 affected2,333 at risk EG0010 affected2,345 at risk EG0022 affected2,342 at risk
Tongue injury	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0012 affected2,345 at risk EG0020 affected2,342 at risk
Traumatic haematoma	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Traumatic haemorrhage	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Traumatic intracranial haemorrhage	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Traumatic liver injury	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Traumatic renal injury	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Ulna fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0021 affected2,342 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0022 affected2,342 at risk
Vascular graft occlusion	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0011 affected2,345 at risk EG0023 affected2,342 at risk
Vascular graft thrombosis	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0022 affected2,342 at risk
Wound	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0013 affected2,345 at risk EG0021 affected2,342 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0021 affected2,342 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0021 affected2,342 at risk
Alanine aminotransferase increased	Investigations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Angiogram	Investigations	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Angiogram normal	Investigations	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Anticoagulation drug level above therapeutic	Investigations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Arteriogram coronary	Investigations	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Biopsy lung	Investigations	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Blood calcium decreased	Investigations	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Blood creatine phosphokinase MB increased	Investigations	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0012 affected2,345 at risk EG0020 affected2,342 at risk
Blood creatinine increased	Investigations	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0011 affected2,345 at risk EG0022 affected2,342 at risk
Blood glucose fluctuation	Investigations	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Blood lactate dehydrogenase increased	Investigations	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Blood magnesium decreased	Investigations	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Blood potassium increased	Investigations	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Blood pressure increased	Investigations	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Blood pressure orthostatic decreased	Investigations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Blood urea increased	Investigations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
C-reactive protein increased	Investigations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0012 affected2,345 at risk EG0020 affected2,342 at risk
Cardiac murmur	Investigations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Cardiac stress test abnormal	Investigations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Catheterisation cardiac	Investigations	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0012 affected2,345 at risk EG0020 affected2,342 at risk
Ejection fraction decreased	Investigations	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Electrocardiogram T wave inversion	Investigations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0021 affected2,342 at risk
Haemoglobin decreased	Investigations	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Heart rate irregular	Investigations	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Hepatic enzyme increased	Investigations	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0013 affected2,345 at risk EG0020 affected2,342 at risk
Lipase increased	Investigations	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Liver function test abnormal	Investigations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Oxygen consumption increased	Investigations	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Physical examination	Investigations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Prostatic specific antigen increased	Investigations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Scan myocardial perfusion abnormal	Investigations	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Smear cervix abnormal	Investigations	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Transaminases increased	Investigations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Troponin I increased	Investigations	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Troponin increased	Investigations	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Weight decreased	Investigations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0022 affected2,342 at risk
White blood cell count increased	Investigations	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0021 affected2,342 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0005 affected2,333 at risk EG0015 affected2,345 at risk EG0025 affected2,342 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0006 affected2,333 at risk EG0013 affected2,345 at risk EG0022 affected2,342 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0006 affected2,333 at risk EG0018 affected2,345 at risk EG0023 affected2,342 at risk
Diabetic complication	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0013 affected2,345 at risk EG0021 affected2,342 at risk
Diabetic metabolic decompensation	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Gout	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0022 affected2,342 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG00014 affected2,333 at risk EG0015 affected2,345 at risk EG0023 affected2,342 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0005 affected2,333 at risk EG0012 affected2,345 at risk EG0023 affected2,342 at risk
Hypernatraemia	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Hypervolaemia	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG00017 affected2,333 at risk EG00110 affected2,345 at risk EG0029 affected2,342 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0012 affected2,345 at risk EG0022 affected2,342 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Insulin resistance	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Lactic acidosis	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Lipomatosis	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0022 affected2,342 at risk
Obesity	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected2,333 at risk EG0012 affected2,345 at risk EG0021 affected2,342 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0004 affected2,333 at risk EG0011 affected2,345 at risk EG0025 affected2,342 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0012 affected2,345 at risk EG0021 affected2,342 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0009 affected2,333 at risk EG0013 affected2,345 at risk EG0028 affected2,342 at risk
Bone fistula	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0011 affected2,345 at risk EG0022 affected2,342 at risk
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Dactylitis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Dupuytren's contracture	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Fistula	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0021 affected2,342 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0011 affected2,345 at risk EG0022 affected2,342 at risk
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Fracture delayed union	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Fracture nonunion	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Gouty arthritis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Gouty tophus	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Intervertebral disc compression	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0021 affected2,342 at risk
Intervertebral disc disorder	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG00010 affected2,333 at risk EG0014 affected2,345 at risk EG0026 affected2,342 at risk
Lower extremity mass	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0011 affected2,345 at risk EG0023 affected2,342 at risk
Muscle tightness	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Muscle twitching	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0010 affected2,345 at risk EG0022 affected2,342 at risk
Musculoskeletal disorder	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected2,333 at risk EG0012 affected2,345 at risk EG0023 affected2,342 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected2,333 at risk EG0012 affected2,345 at risk EG0021 affected2,342 at risk
Myofascial pain syndrome	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Myositis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0012 affected2,345 at risk EG0020 affected2,342 at risk
Neuropathic arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0012 affected2,345 at risk EG0020 affected2,342 at risk
Osteitis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Osteitis deformans	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG00015 affected2,333 at risk EG00115 affected2,345 at risk EG00217 affected2,342 at risk
Osteomalacia	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Osteoporotic fracture	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0004 affected2,333 at risk EG0013 affected2,345 at risk EG0026 affected2,342 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0011 affected2,345 at risk EG0021 affected2,342 at risk
Periarthritis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0023 affected2,342 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0011 affected2,345 at risk EG0025 affected2,342 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0016 affected2,345 at risk EG0021 affected2,342 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0006 affected2,333 at risk EG0012 affected2,345 at risk EG0021 affected2,342 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected2,333 at risk EG0011 affected2,345 at risk EG0022 affected2,342 at risk
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Spondylitis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0021 affected2,342 at risk
Synovitis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Tenosynovitis stenosans	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Trigger finger	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Acoustic neuroma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0013 affected2,345 at risk EG0020 affected2,342 at risk
Acute lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Adenocarcinoma gastric	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0012 affected2,345 at risk EG0022 affected2,342 at risk
Adenocarcinoma pancreas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0013 affected2,345 at risk EG0023 affected2,342 at risk
Adenoma benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Anogenital warts	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG00016 affected2,333 at risk EG00115 affected2,345 at risk EG00212 affected2,342 at risk
Basosquamous carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Benign hepatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Benign laryngeal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Benign lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Benign neoplasm of adrenal gland	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Benign neoplasm of bladder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Benign neoplasm of prostate	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Benign neoplasm of thyroid gland	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Benign pancreatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Benign respiratory tract neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Benign uterine neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Bile duct cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0025 affected2,342 at risk
Bladder cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0021 affected2,342 at risk
Bone cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Bone giant cell tumour benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Bowen's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0022 affected2,342 at risk
Brain neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0012 affected2,345 at risk EG0022 affected2,342 at risk
Bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Cardiac myxoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Cervix carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Cholesteatoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Chronic lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0013 affected2,345 at risk EG0020 affected2,342 at risk
Clear cell renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0003 affected2,333 at risk EG0012 affected2,345 at risk EG0021 affected2,342 at risk
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0015 affected2,345 at risk EG0021 affected2,342 at risk
Colon cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0023 affected2,342 at risk
Colon neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Colorectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Colorectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Endometrial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Fibroadenoma of breast	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Fibrosarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Follicular thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Gastrointestinal stromal tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Genital neoplasm malignant female	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Haemangioma of bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Haemangioma of liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Hepatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Hepatocellular carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0013 affected2,345 at risk EG0021 affected2,342 at risk
Hodgkin's disease stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Intraductal proliferative breast lesion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Keratoacanthoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0012 affected2,345 at risk EG0021 affected2,342 at risk
Large cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Laryngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0022 affected2,342 at risk
Laryngeal squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0022 affected2,342 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0015 affected2,345 at risk EG0023 affected2,342 at risk
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Lung carcinoma cell type unspecified stage III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0003 affected2,333 at risk EG0011 affected2,345 at risk EG0027 affected2,342 at risk
Lung squamous cell carcinoma stage III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Lymphocytic lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Lymphoproliferative disorder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0013 affected2,345 at risk EG0023 affected2,342 at risk
Malignant melanoma in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0021 affected2,342 at risk
Malignant neoplasm of unknown primary site	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0012 affected2,345 at risk EG0020 affected2,342 at risk
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0012 affected2,345 at risk EG0020 affected2,342 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0003 affected2,333 at risk EG0015 affected2,345 at risk EG0025 affected2,342 at risk
Metastases to lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0012 affected2,345 at risk EG0022 affected2,342 at risk
Metastases to lymph nodes	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Metastases to neck	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Metastases to peritoneum	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Metastases to pleura	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Metastasis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Metastatic malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Metastatic renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Nasopharyngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0022 affected2,342 at risk
Neuroendocrine carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Neuroendocrine carcinoma of the skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Non-Hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Non-Hodgkin's lymphoma stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Oesophageal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Oesophageal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
POEMS syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0012 affected2,345 at risk EG0022 affected2,342 at risk
Papillary serous endometrial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Papillary thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Parathyroid tumour benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Penile squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Pituitary tumour benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0012 affected2,345 at risk EG0021 affected2,342 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0009 affected2,333 at risk EG00111 affected2,345 at risk EG0029 affected2,342 at risk
Prostate cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Prostatic adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0012 affected2,345 at risk EG0020 affected2,342 at risk
Rectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0014 affected2,345 at risk EG0023 affected2,342 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0013 affected2,345 at risk EG0020 affected2,342 at risk
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Renal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0012 affected2,345 at risk EG0021 affected2,342 at risk
Renal cell carcinoma stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Renal cell carcinoma stage II	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Salivary gland adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Salivary gland neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Sarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Skin cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Small cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Splenic marginal zone lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0003 affected2,333 at risk EG0016 affected2,345 at risk EG0023 affected2,342 at risk
Squamous cell carcinoma of lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0013 affected2,345 at risk EG0020 affected2,342 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0007 affected2,333 at risk EG0014 affected2,345 at risk EG0023 affected2,342 at risk
Squamous cell carcinoma of the oral cavity	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Thyroid neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Tongue neoplasm malignant stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0003 affected2,333 at risk EG0011 affected2,345 at risk EG0021 affected2,342 at risk
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Uterine cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Altered state of consciousness	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Amnesia	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Aphasia	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Autonomic neuropathy	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Balance disorder	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Brain oedema	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Brain stem haemorrhage	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Brain stem infarction	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0022 affected2,342 at risk
Brain stem ischaemia	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Brain stem stroke	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Carotid arteriosclerosis	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Carotid artery disease	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Carotid artery occlusion	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0024 affected2,342 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG00010 affected2,333 at risk EG0017 affected2,345 at risk EG00212 affected2,342 at risk
Carotid artery thrombosis	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected2,333 at risk EG0011 affected2,345 at risk EG0021 affected2,342 at risk
Central nervous system inflammation	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Cerebellar infarction	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0012 affected2,345 at risk EG0022 affected2,342 at risk
Cerebral arteriosclerosis	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Cerebral artery occlusion	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0011 affected2,345 at risk EG0021 affected2,342 at risk
Cerebral artery stenosis	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Cerebral ataxia	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Cerebral infarction	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0007 affected2,333 at risk EG0017 affected2,345 at risk EG00211 affected2,342 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0013 affected2,345 at risk EG0021 affected2,342 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG00031 affected2,333 at risk EG00146 affected2,345 at risk EG00237 affected2,342 at risk
Cerebrovascular disorder	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Cerebrovascular insufficiency	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Cervical cord compression	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Cervical myelopathy	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0022 affected2,342 at risk
Cervical radiculopathy	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0011 affected2,345 at risk EG0021 affected2,342 at risk
Cognitive disorder	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0022 affected2,342 at risk
Complex partial seizures	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Coordination abnormal	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Dementia Alzheimer's type	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Diabetic neuropathy	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0012 affected2,345 at risk EG0021 affected2,342 at risk
Dizziness	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0005 affected2,333 at risk EG0018 affected2,345 at risk EG0025 affected2,342 at risk
Dysarthria	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Embolic cerebral infarction	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Embolic stroke	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Encephalopathy	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Epilepsy	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0012 affected2,345 at risk EG0022 affected2,342 at risk
Generalised tonic-clonic seizure	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Guillain-Barre syndrome	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Haemorrhagic cerebral infarction	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Haemorrhagic stroke	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0004 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Headache	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Hemiparesis	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0022 affected2,342 at risk
Hemiplegia	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Hydrocephalus	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Hypercapnic coma	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Hyperkinesia	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Hypertensive encephalopathy	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0011 affected2,345 at risk EG0021 affected2,342 at risk
Hypoglycaemic coma	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Hypotonia	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
IIIrd nerve paralysis	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Intercostal neuralgia	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0022 affected2,342 at risk
Ischaemic cerebral infarction	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG00022 affected2,333 at risk EG00118 affected2,345 at risk EG00220 affected2,342 at risk
Lacunar infarction	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0011 affected2,345 at risk EG0022 affected2,342 at risk
Leukoencephalopathy	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Loss of consciousness	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0010 affected2,345 at risk EG0022 affected2,342 at risk
Lumbar radiculopathy	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Metabolic encephalopathy	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Migraine	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Mononeuritis	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Monoplegia	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Muscle spasticity	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Myelitis transverse	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Myelopathy	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Myoclonus	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0021 affected2,342 at risk
Nerve root compression	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Neuroleptic malignant syndrome	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Paraesthesia	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Paraparesis	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Paraplegia	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Parkinson's disease	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Partial seizures	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Peripheral motor neuropathy	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Peroneal nerve palsy	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Petit mal epilepsy	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Piriformis syndrome	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Presyncope	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0021 affected2,342 at risk
Radiculopathy	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Sciatica	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0012 affected2,345 at risk EG0021 affected2,342 at risk
Seizure	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0004 affected2,333 at risk EG0017 affected2,345 at risk EG0025 affected2,342 at risk
Sensory disturbance	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Spinal cord compression	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Spinal epidural haematoma	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Spondylitic myelopathy	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected2,333 at risk EG0013 affected2,345 at risk EG0022 affected2,342 at risk
Subdural hygroma	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Syncope	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0008 affected2,333 at risk EG0019 affected2,345 at risk EG00218 affected2,342 at risk
Thalamic infarction	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Thrombotic cerebral infarction	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Thrombotic stroke	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG00023 affected2,333 at risk EG00123 affected2,345 at risk EG00230 affected2,342 at risk
VIIth nerve paralysis	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Vascular encephalopathy	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Vertebral artery dissection	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0021 affected2,342 at risk
Vertebral artery stenosis	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Vertebrobasilar insufficiency	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Vocal cord paresis	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Anxiety	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0004 affected2,333 at risk EG0011 affected2,345 at risk EG0021 affected2,342 at risk
Completed suicide	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Confusional state	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0013 affected2,345 at risk EG0020 affected2,342 at risk
Delirium	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0012 affected2,345 at risk EG0021 affected2,342 at risk
Depression	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0005 affected2,333 at risk EG0011 affected2,345 at risk EG0021 affected2,342 at risk
Hallucination	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Insomnia	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Major depression	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0021 affected2,342 at risk
Mental status changes	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0004 affected2,333 at risk EG0011 affected2,345 at risk EG0021 affected2,342 at risk
Rapid eye movements sleep abnormal	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Substance abuse	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Suicidal ideation	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Suicide attempt	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0011 affected2,345 at risk EG0021 affected2,342 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG00032 affected2,333 at risk EG00126 affected2,345 at risk EG00219 affected2,342 at risk
Acute prerenal failure	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Albuminuria	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Anuria	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Bladder neck sclerosis	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Bladder outlet obstruction	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Calculus bladder	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Calculus ureteric	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0004 affected2,333 at risk EG0011 affected2,345 at risk EG0022 affected2,342 at risk
Calculus urinary	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected2,333 at risk EG0012 affected2,345 at risk EG0024 affected2,342 at risk
Cystitis glandularis	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Cystitis haemorrhagic	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Diabetic nephropathy	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0012 affected2,345 at risk EG0022 affected2,342 at risk
Dysuria	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Haematuria	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0004 affected2,333 at risk EG0012 affected2,345 at risk EG0021 affected2,342 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0012 affected2,345 at risk EG0020 affected2,342 at risk
Hypertensive nephropathy	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Lower urinary tract symptoms	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Microalbuminuria	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Nephritis	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected2,333 at risk EG0013 affected2,345 at risk EG0027 affected2,342 at risk
Nephropathy	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0011 affected2,345 at risk EG0021 affected2,342 at risk
Nephrotic syndrome	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Obstructive uropathy	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0021 affected2,342 at risk
Oliguria	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Polyuria	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Renal artery arteriosclerosis	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Renal artery stenosis	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Renal colic	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Renal cyst	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Renal failure	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG00010 affected2,333 at risk EG0012 affected2,345 at risk EG0024 affected2,342 at risk
Renal impairment	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0012 affected2,345 at risk EG0024 affected2,342 at risk
Renal infarct	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0012 affected2,345 at risk EG0020 affected2,342 at risk
Renal tubular necrosis	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Stress urinary incontinence	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Tubulointerstitial nephritis	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Ureteric obstruction	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0022 affected2,342 at risk
Urethral stenosis	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0014 affected2,345 at risk EG0020 affected2,342 at risk
Urinary bladder haemorrhage	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Urinary bladder polyp	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Urinary retention	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected2,333 at risk EG0014 affected2,345 at risk EG0025 affected2,342 at risk
Urinary tract obstruction	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 18.0	Systematic Assessment	EG0006 affected2,333 at risk EG0018 affected2,345 at risk EG00210 affected2,342 at risk
Cystocele	Reproductive system and breast disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Endometrial hyperplasia	Reproductive system and breast disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Fibrocystic breast disease	Reproductive system and breast disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Genital prolapse	Reproductive system and breast disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Gynaecomastia	Reproductive system and breast disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Menorrhagia	Reproductive system and breast disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0021 affected2,342 at risk
Prostatic obstruction	Reproductive system and breast disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Prostatism	Reproductive system and breast disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0022 affected2,342 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0012 affected2,345 at risk EG0022 affected2,342 at risk
Uterine polyp	Reproductive system and breast disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Uterine prolapse	Reproductive system and breast disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0021 affected2,342 at risk
Uterovaginal prolapse	Reproductive system and breast disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Vaginal prolapse	Reproductive system and breast disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0005 affected2,333 at risk EG0017 affected2,345 at risk EG0021 affected2,342 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0004 affected2,333 at risk EG0015 affected2,345 at risk EG0023 affected2,342 at risk
Allergic sinusitis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0006 affected2,333 at risk EG0014 affected2,345 at risk EG0022 affected2,342 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0023 affected2,342 at risk
Bronchial disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Bronchial secretion retention	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Bronchiectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Bronchitis chronic	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0012 affected2,345 at risk EG0021 affected2,342 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG00011 affected2,333 at risk EG0016 affected2,345 at risk EG00210 affected2,342 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG00014 affected2,333 at risk EG0016 affected2,345 at risk EG0029 affected2,342 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Emphysema	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0013 affected2,345 at risk EG0022 affected2,342 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0004 affected2,333 at risk EG0011 affected2,345 at risk EG0021 affected2,342 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Hydrothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0012 affected2,345 at risk EG0021 affected2,342 at risk
Idiopathic pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0022 affected2,342 at risk
Laryngeal oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Mediastinal haematoma	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Nasal polyps	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Obstructive airways disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Paranasal cyst	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0004 affected2,333 at risk EG0011 affected2,345 at risk EG0024 affected2,342 at risk
Pleural fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Pulmonary arterial hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0022 affected2,342 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0004 affected2,333 at risk EG0010 affected2,345 at risk EG0026 affected2,342 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0021 affected2,342 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0005 affected2,333 at risk EG0011 affected2,345 at risk EG0022 affected2,342 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0005 affected2,333 at risk EG0012 affected2,345 at risk EG0021 affected2,342 at risk
Pulmonary thrombosis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Pulmonary toxicity	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0009 affected2,333 at risk EG0012 affected2,345 at risk EG0024 affected2,342 at risk
Sinus disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0004 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Status asthmaticus	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Upper airway obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Vocal cord polyp	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Vocal cord thickening	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0023 affected2,342 at risk
Cold sweat	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Dermal cyst	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Diabetic bullosis	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG00012 affected2,333 at risk EG00110 affected2,345 at risk EG00211 affected2,342 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Erythrodermic psoriasis	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Ingrowing nail	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Leukoplakia	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Neuropathic ulcer	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Pemphigus	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Skin fibrosis	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Skin necrosis	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG00010 affected2,333 at risk EG0016 affected2,345 at risk EG00211 affected2,342 at risk
Skin ulcer haemorrhage	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Physical assault	Social circumstances	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Angioplasty	Surgical and medical procedures	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0011 affected2,345 at risk EG0021 affected2,342 at risk
Coronary angioplasty	Surgical and medical procedures	MedDRA 18.0	Systematic Assessment	EG0003 affected2,333 at risk EG0010 affected2,345 at risk EG0022 affected2,342 at risk
Coronary arterial stent insertion	Surgical and medical procedures	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0012 affected2,345 at risk EG0021 affected2,342 at risk
Coronary artery bypass	Surgical and medical procedures	MedDRA 18.0	Systematic Assessment	EG0004 affected2,333 at risk EG0013 affected2,345 at risk EG0024 affected2,342 at risk
Coronary revascularisation	Surgical and medical procedures	MedDRA 18.0	Systematic Assessment	EG0005 affected2,333 at risk EG0012 affected2,345 at risk EG0024 affected2,342 at risk
Fracture treatment	Surgical and medical procedures	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Percutaneous coronary intervention	Surgical and medical procedures	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0012 affected2,345 at risk EG0023 affected2,342 at risk
Prophylaxis	Surgical and medical procedures	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Stent placement	Surgical and medical procedures	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0012 affected2,345 at risk EG0021 affected2,342 at risk
Accelerated hypertension	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0021 affected2,342 at risk
Aneurysm	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Angiopathy	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Aortic aneurysm	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0013 affected2,345 at risk EG0024 affected2,342 at risk
Aortic arteriosclerosis	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Aortic dissection	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Aortic stenosis	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0004 affected2,333 at risk EG0012 affected2,345 at risk EG0023 affected2,342 at risk
Arterial disorder	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0004 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Arterial haemorrhage	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Arterial occlusive disease	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Arterial stenosis	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Arteriosclerosis	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0011 affected2,345 at risk EG0021 affected2,342 at risk
Arteriovenous fistula	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Arteritis	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0023 affected2,342 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0005 affected2,333 at risk EG0013 affected2,345 at risk EG00210 affected2,342 at risk
Diabetic microangiopathy	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Embolism	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Embolism arterial	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Extremity necrosis	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0005 affected2,333 at risk EG0014 affected2,345 at risk EG0028 affected2,342 at risk
Femoral artery embolism	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Femoral artery occlusion	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0013 affected2,345 at risk EG0025 affected2,342 at risk
Haematoma	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0022 affected2,342 at risk
Haemorrhage	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Hypertension	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG00010 affected2,333 at risk EG0014 affected2,345 at risk EG0027 affected2,342 at risk
Hypertensive crisis	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0008 affected2,333 at risk EG0013 affected2,345 at risk EG0024 affected2,342 at risk
Hypertensive emergency	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Hypotension	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0009 affected2,333 at risk EG0015 affected2,345 at risk EG0024 affected2,342 at risk
Hypovolaemic shock	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Iliac artery occlusion	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0022 affected2,342 at risk
Infarction	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0022 affected2,342 at risk
Intermittent claudication	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0014 affected2,345 at risk EG0025 affected2,342 at risk
Ischaemia	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0011 affected2,345 at risk EG0022 affected2,342 at risk
Leriche syndrome	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Malignant hypertension	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0013 affected2,345 at risk EG0021 affected2,342 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG00023 affected2,333 at risk EG00128 affected2,345 at risk EG00230 affected2,342 at risk
Peripheral artery aneurysm	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Peripheral artery stenosis	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0006 affected2,333 at risk EG0013 affected2,345 at risk EG0029 affected2,342 at risk
Peripheral artery thrombosis	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Peripheral coldness	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Peripheral embolism	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0009 affected2,333 at risk EG0014 affected2,345 at risk EG00211 affected2,342 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0008 affected2,333 at risk EG0013 affected2,345 at risk EG0026 affected2,342 at risk
Peripheral venous disease	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Subclavian artery stenosis	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0021 affected2,342 at risk
Thrombophlebitis	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Thrombophlebitis superficial	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Thrombosis	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0012 affected2,345 at risk EG0022 affected2,342 at risk
Varicose ulceration	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Varicose vein	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Vascular calcification	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0011 affected2,345 at risk EG0020 affected2,342 at risk
Vascular insufficiency	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk
Venous occlusion	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected2,333 at risk EG0010 affected2,345 at risk EG0020 affected2,342 at risk
Venous thrombosis	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0011 affected2,345 at risk EG0021 affected2,342 at risk
Venous thrombosis limb	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected2,333 at risk EG0010 affected2,345 at risk EG0021 affected2,342 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Constipation	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG000109 affected2,333 at risk EG00191 affected2,345 at risk EG002119 affected2,342 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG000171 affected2,333 at risk EG001145 affected2,345 at risk EG002144 affected2,342 at risk
Oedema peripheral	General disorders	MedDRA 18.0	Systematic Assessment	EG000155 affected2,333 at risk EG00184 affected2,345 at risk EG00275 affected2,342 at risk
Bronchitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG000164 affected2,333 at risk EG001129 affected2,345 at risk EG002117 affected2,342 at risk
Influenza	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG000165 affected2,333 at risk EG001134 affected2,345 at risk EG002149 affected2,342 at risk
Nasopharyngitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG000217 affected2,333 at risk EG001210 affected2,345 at risk EG002220 affected2,342 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG000199 affected2,333 at risk EG001191 affected2,345 at risk EG002175 affected2,342 at risk
Urinary tract infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG000344 affected2,333 at risk EG001339 affected2,345 at risk EG002337 affected2,342 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG000423 affected2,333 at risk EG001217 affected2,345 at risk EG002202 affected2,342 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG000685 affected2,333 at risk EG001694 affected2,345 at risk EG002673 affected2,342 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG000130 affected2,333 at risk EG001107 affected2,345 at risk EG002148 affected2,342 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG000148 affected2,333 at risk EG001149 affected2,345 at risk EG002166 affected2,342 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG000133 affected2,333 at risk EG001114 affected2,345 at risk EG002101 affected2,342 at risk
Dizziness	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG000151 affected2,333 at risk EG001170 affected2,345 at risk EG002173 affected2,342 at risk
Headache	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG000123 affected2,333 at risk EG001100 affected2,345 at risk EG002124 affected2,342 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG000146 affected2,333 at risk EG001119 affected2,345 at risk EG002108 affected2,342 at risk
Hypertension	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG000210 affected2,333 at risk EG001154 affected2,345 at risk EG002176 affected2,342 at risk

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Title	Description
BG000	Placebo	Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily)
BG001	Empagliflozin 10 mg	Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily)
BG002	Empagliflozin 25 mg	Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily)
BG003	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily)	988	2,333	1,690	2,333
EG001	Empagliflozin 10 mg	Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily)	876	2,345	1,556	2,345
EG002	Empagliflozin 25 mg	Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily)	913	2,342	1,551	2,342