Study to Evaluate Potential Decrease in Hospitalization E... | NCT00090259

ID	Type	Description	Link
2004_004

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Losartan 50 mg	Experimental	50-mg losartan tablet administered daily with 1 tablet of 100-mg losartan placebo beginning Week 1 and continuing to end of study (up to 4 years)	Drug: Losartan 50 mg
Losartan 150 mg	Experimental	Titrated losartan administration up to daily 150-mg losartan: Week 1, daily 50-mg losartan tablet coadministered with 100-mg losartan placebo; Week 2, daily 50-mg losartan placebo coadministered with 100-mg losartan; Week 3 to end of study (up to 4 years), daily 50-mg losartan tablet coadministered with 100-mg losartan	Drug: Losartan 150 mg

Name	Type	Description	Arm Group Labels	Other Names
Losartan 50 mg	Drug	50-mg losartan oral tablet	Losartan 50 mg	Losartan potassium

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants That Experienced One Component of the Composite Clinical Endpoint of All Cause Death or Hospitalization for Heart Failure		Entire follow-up (median = 4.7 years)

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants That Experienced One Components of the Composite Clinical Endpoint of All Cause Death or Cardiovascular Hospitalization	Cardiovascular hospitalization is defined as any hospitalization that may be attributed to a cardiovascular cause, including heart failure.	Entire follow-up (median = 4.7 years)

Eligibility Module

Name	Affiliation	Role
Medical Monitor	Merck Sharp & Dohme LLC	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27514751	Derived	Upshaw JN, Konstam MA, Klaveren Dv, Noubary F, Huggins GS, Kent DM. Multistate Model to Predict Heart Failure Hospitalizations and All-Cause Mortality in Outpatients With Heart Failure With Reduced Ejection Fraction: Model Derivation and External Validation. Circ Heart Fail. 2016 Aug;9(8):e003146. doi: 10.1161/CIRCHEARTFAILURE.116.003146.
25828348

Results Section

Participant Flow Module

ID	Title	Description
FG000	Losartan 50 mg
FG001	Losartan 150 mg

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

ID	Title	Description
BG000	Losartan 50 mg
BG001	Losartan 150 mg
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG0001913 BG0011921 BG0023834

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Full Range

years

Title

Denominators

Categories

Title	Measurements
	BG00064.1(19 to 95) BG00164.4(18 to 98) BG00264.2(18 to 98)

Age, Customized

Number

participants

Title

Denominators

Categories

< 65 years of Age

Title	Measurements
	BG000889 BG001879 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000560 BG001583 BG002

Angiotensin II antagonists

Number

Participants

Title

Denominators

Categories

Title	Measurements
	BG000456 BG001438 BG002

New York Heart Association (NYHA) functional status

NYHA Class Symptoms

I No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc.

II Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity.

III Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m). Comfortable only at rest.

IV Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.

Number

Participants

Title

Denominators

Categories

I No symptoms

Title	Measurements
	BG0002 BG001

Region

Number

participants

Title

Denominators

Categories

Asia and Pacific Region

Title	Measurements
	BG000391 BG001390 BG002

β - Blocker therapy

Number

Participants

Title

Denominators

Categories

Title	Measurements
	BG000543 BG001533 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants That Experienced One Component of the Composite Clinical Endpoint of All Cause Death or Hospitalization for Heart Failure

Intention-to-Treat

Posted

Number

Participants

Entire follow-up (median = 4.7 years)

ID	Title	Description
OG000	Losartan 50 mg
OG001	Losartan 150 mg

Units	Counts
Participants	OG0001913 OG0011921

Title

Denominators

Categories

Title	Measurements
	OG000889 OG001828

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Regression, Cox	Model terms: treatment, region and β-blocker use at randomization	0.027		Hazard Ratio (HR)	0.899			2-Sided	95	0.818	0.988			Direction of the Comparison: Hazard Ratio of experiencing the endpoint on Losartan 150 mg compared to Losartan 50 mg		Superiority or Other (legacy)

Secondary

Number of Participants That Experienced One Components of the Composite Clinical Endpoint of All Cause Death or Cardiovascular Hospitalization

Cardiovascular hospitalization is defined as any hospitalization that may be attributed to a cardiovascular cause, including heart failure.

Intention-to-Treat

Posted

Number

Participants

Entire follow-up (median = 4.7 years)

ID	Title	Description
OG000	Losartan 50 mg
OG001	Losartan 150 mg

Units	Counts
Participants	OG000

Secondary

Number of Participants That Died (Any Cause)

Intention-to-Treat

Posted

Number

Participants

Entire follow-up (median = 4.7 years)

ID	Title	Description
OG000	Losartan 50 mg
OG001	Losartan 150 mg

Units	Counts
Participants	OG0001913 OG001

Secondary

Number of Participants That Were Hospitalized for Heart Failure

Intention-to-Treat

Posted

Number

Participants

Entire follow-up (median = 4.7 years)

ID	Title	Description
OG000	Losartan 50 mg
OG001	Losartan 150 mg

Units	Counts
Participants	OG0001913 OG001

Secondary

Number of Participants That Experienced Cardiovascular Hospitalization

Intention-to-Treat

Posted

Number

Participants

Entire follow-up (median = 4.7 years)

ID	Title	Description
OG000	Losartan 50 mg
OG001	Losartan 150 mg

Units	Counts
Participants	OG0001913 OG001

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acquired haemophilia with anti FVIII, XI, or XIII	Blood and lymphatic system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (12.0)	Systematic Assessment	EG00019 affected1,913 at risk EG00124 affected1,921 at risk
Anaemia macrocytic	Blood and lymphatic system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0012 affected1,921 at risk
Anaemia megaloblastic	Blood and lymphatic system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Anaemia vitamin B12 deficiency	Blood and lymphatic system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Bone marrow failure	Blood and lymphatic system disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0010 affected1,921 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Haemolysis	Blood and lymphatic system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Haemolytic anaemia	Blood and lymphatic system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0011 affected1,921 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0011 affected1,921 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Lymphadenopathy mediastinal	Blood and lymphatic system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Microcytic anaemia	Blood and lymphatic system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Nephrogenic anaemia	Blood and lymphatic system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0012 affected1,921 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0012 affected1,921 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Angina pectoris	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0011 affected1,921 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0016 affected1,921 at risk
Atrial flutter	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0013 affected1,921 at risk
Atrial tachycardia	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Cardiac arrest	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Cardiac failure	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0008 affected1,913 at risk EG0015 affected1,921 at risk
Cardiogenic shock	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Cyanosis	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Intracardiac thrombus	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Myocardial infarction	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Silent myocardial infarction	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0010 affected1,921 at risk
Tachyarrhythmia	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Ventricular arrhythmia	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0011 affected1,921 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0013 affected1,921 at risk
Hydrocele	Congenital, familial and genetic disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0012 affected1,921 at risk
Muscular dystrophy	Congenital, familial and genetic disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Meniere's disease	Ear and labyrinth disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0011 affected1,921 at risk
Sudden hearing loss	Ear and labyrinth disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Vertigo	Ear and labyrinth disorders	MedDRA (12.0)	Systematic Assessment	EG0003 affected1,913 at risk EG0012 affected1,921 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Vestibular disorder	Ear and labyrinth disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0011 affected1,921 at risk
Adrenal mass	Endocrine disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Goitre	Endocrine disorders	MedDRA (12.0)	Systematic Assessment	EG0003 affected1,913 at risk EG0011 affected1,921 at risk
Hyperthyroidism	Endocrine disorders	MedDRA (12.0)	Systematic Assessment	EG0005 affected1,913 at risk EG0010 affected1,921 at risk
Hypothyroidism	Endocrine disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0014 affected1,921 at risk
Cataract	Eye disorders	MedDRA (12.0)	Systematic Assessment	EG00013 affected1,913 at risk EG0017 affected1,921 at risk
Diabetic retinopathy	Eye disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0012 affected1,921 at risk
Eye haemorrhage	Eye disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Glaucoma	Eye disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Ocular hypertension	Eye disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Ophthalmoplegia	Eye disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Parophthalmia	Eye disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Retinal detachment	Eye disorders	MedDRA (12.0)	Systematic Assessment	EG0003 affected1,913 at risk EG0010 affected1,921 at risk
Retinopathy	Eye disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0010 affected1,921 at risk
Visual acuity reduced	Eye disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Visual impairment	Eye disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0009 affected1,913 at risk EG0012 affected1,921 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0011 affected1,921 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0004 affected1,913 at risk EG0017 affected1,921 at risk
Abdominal strangulated hernia	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0012 affected1,921 at risk
Acute abdomen	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0010 affected1,921 at risk
Anal fissure	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0012 affected1,921 at risk
Anal fistula	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0011 affected1,921 at risk
Anal ulcer	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Aphagia	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Ascites	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0010 affected1,921 at risk
Barrett's oesophagus	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Colitis	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0012 affected1,921 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Colitis ulcerative	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Colonic polyp	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0003 affected1,913 at risk EG0014 affected1,921 at risk
Constipation	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0004 affected1,913 at risk EG0013 affected1,921 at risk
Dental caries	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0012 affected1,921 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0006 affected1,913 at risk EG0015 affected1,921 at risk
Diverticulum	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0011 affected1,921 at risk
Diverticulum intestinal	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Diverticulum intestinal haemorrhagic	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0011 affected1,921 at risk
Dry mouth	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Duodenal perforation	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Duodenal stenosis	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0004 affected1,913 at risk EG0012 affected1,921 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0003 affected1,913 at risk EG0013 affected1,921 at risk
Duodenal ulcer perforation	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Duodenitis haemorrhagic	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Dysphagia	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0014 affected1,921 at risk
Enteritis	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0011 affected1,921 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Faecaloma	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0012 affected1,921 at risk
Femoral hernia	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Femoral hernia, obstructive	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Gastric antral vascular ectasia	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Gastric disorder	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0012 affected1,921 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0005 affected1,913 at risk EG0017 affected1,921 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0012 affected1,921 at risk
Gastric ulcer perforation	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Gastritis	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0007 affected1,913 at risk EG00112 affected1,921 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0003 affected1,913 at risk EG0012 affected1,921 at risk
Gastritis haemorrhagic	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0014 affected1,921 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG00013 affected1,913 at risk EG00113 affected1,921 at risk
Gastrointestinal hypomotility	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Gastrointestinal necrosis	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Gastrointestinal ulcer haemorrhage	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0013 affected1,921 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0011 affected1,921 at risk
Giant cell epulis	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Haematemesis	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0003 affected1,913 at risk EG0011 affected1,921 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0011 affected1,921 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0011 affected1,921 at risk
Ileus	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0013 affected1,921 at risk
Ileus paralytic	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0010 affected1,921 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG00018 affected1,913 at risk EG00111 affected1,921 at risk
Inguinal hernia strangulated	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Intestinal haemorrhage	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0006 affected1,913 at risk EG0013 affected1,921 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Intestinal polyp	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Intra-abdominal haematoma	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0011 affected1,921 at risk
Jejunal perforation	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Large intestinal haemorrhage	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0012 affected1,921 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0003 affected1,913 at risk EG0014 affected1,921 at risk
Mallory-Weiss syndrome	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0012 affected1,921 at risk
Melaena	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0010 affected1,921 at risk
Nausea	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0011 affected1,921 at risk
Oesophageal disorder	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Oesophageal stenosis	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Oesophageal ulcer	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0012 affected1,921 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0007 affected1,913 at risk EG0016 affected1,921 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0005 affected1,913 at risk EG0016 affected1,921 at risk
Pancreatitis chronic	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Pancreatitis necrotising	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Peptic ulcer	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0003 affected1,913 at risk EG0012 affected1,921 at risk
Periodontitis	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Peritoneal effusion	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Peritonitis	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0003 affected1,913 at risk EG0013 affected1,921 at risk
Pharyngoesophageal diverticulum	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Polyp colorectal	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0011 affected1,921 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0016 affected1,921 at risk
Rectal polyp	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Rectal prolapse	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0012 affected1,921 at risk
Reflux oesophagitis	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0003 affected1,913 at risk EG0010 affected1,921 at risk
Retroperitoneal haematoma	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Retroperitoneal haemorrhage	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Small intestinal haemorrhage	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Subileus	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Toothache	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG00012 affected1,913 at risk EG00113 affected1,921 at risk
Volvulus	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Vomiting	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0011 affected1,921 at risk
Blood creatinine increased	General disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0015 affected1,921 at risk
Blood glucose abnormal	General disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Blood glucose increased	General disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0013 affected1,921 at risk
Blood potassium decreased	General disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Blood potassium increased	General disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0013 affected1,921 at risk
Blood pressure increased	General disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Blood sodium decreased	General disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Blood urea increased	General disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0012 affected1,921 at risk
Blood urine present	General disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Cardioactive drug level above therapeutic	General disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Cardioactive drug level increased	General disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Coagulation time abnormal	General disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Coagulation time prolonged	General disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
International normalised ratio increased	General disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0012 affected1,921 at risk
Prothrombin time prolonged	General disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Red blood cell count decreased	General disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Urine cytology abnormal	General disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Weight decreased	General disorders	MedDRA (12.0)	Systematic Assessment	EG0003 affected1,913 at risk EG0013 affected1,921 at risk
Weight increased	General disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
White blood cell count increased	General disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Asthenia	General disorders	MedDRA (12.0)	Systematic Assessment	EG0003 affected1,913 at risk EG0011 affected1,921 at risk
Catheter site haemorrhage	General disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Chest pain	General disorders	MedDRA (12.0)	Systematic Assessment	EG0005 affected1,913 at risk EG0019 affected1,921 at risk
Chills	General disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Drug interaction	General disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0012 affected1,921 at risk
Fatigue	General disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0011 affected1,921 at risk
General physical health deterioration	General disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0012 affected1,921 at risk
Generalised oedema	General disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Granuloma	General disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Hernia	General disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0012 affected1,921 at risk
Hernia obstructive	General disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0014 affected1,921 at risk
Hypothermia	General disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Impaired healing	General disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Implant site haematoma	General disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Implant site inflammation	General disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Malaise	General disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Multi-organ failure	General disorders	MedDRA (12.0)	Systematic Assessment	EG0009 affected1,913 at risk EG0011 affected1,921 at risk
Necrosis	General disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0010 affected1,921 at risk
Non-cardiac chest pain	General disorders	MedDRA (12.0)	Systematic Assessment	EG00011 affected1,913 at risk EG00110 affected1,921 at risk
Oedema	General disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Oedema peripheral	General disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Perforated ulcer	General disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Puncture site haemorrhage	General disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Pyrexia	General disorders	MedDRA (12.0)	Systematic Assessment	EG0004 affected1,913 at risk EG0013 affected1,921 at risk
Sudden death	General disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0011 affected1,921 at risk
Ulcer haemorrhage	General disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Acute hepatic failure	Hepatobiliary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0011 affected1,921 at risk
Bile duct obstruction	Hepatobiliary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0011 affected1,921 at risk
Bile duct stenosis	Hepatobiliary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA (12.0)	Systematic Assessment	EG0003 affected1,913 at risk EG0012 affected1,921 at risk
Biliary colic	Hepatobiliary disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Biliary tract disorder	Hepatobiliary disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Cholangitis	Hepatobiliary disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0013 affected1,921 at risk
Cholangitis acute	Hepatobiliary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0011 affected1,921 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA (12.0)	Systematic Assessment	EG00012 affected1,913 at risk EG00111 affected1,921 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA (12.0)	Systematic Assessment	EG0006 affected1,913 at risk EG0013 affected1,921 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA (12.0)	Systematic Assessment	EG00011 affected1,913 at risk EG00115 affected1,921 at risk
Cirrhosis alcoholic	Hepatobiliary disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Gallbladder disorder	Hepatobiliary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Gallbladder perforation	Hepatobiliary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA (12.0)	Systematic Assessment	EG0004 affected1,913 at risk EG0011 affected1,921 at risk
Hepatitis	Hepatobiliary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Hepatitis acute	Hepatobiliary disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Hepatitis alcoholic	Hepatobiliary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Ischaemic hepatitis	Hepatobiliary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Jaundice	Hepatobiliary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0013 affected1,921 at risk
Jaundice cholestatic	Hepatobiliary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Liver disorder	Hepatobiliary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0012 affected1,921 at risk
Anaphylactic shock	Immune system disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0011 affected1,921 at risk
Behcet's syndrome	Immune system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Contrast media allergy	Immune system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Hypersensitivity	Immune system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Abdominal abscess	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Abdominal infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Abdominal sepsis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Abdominal wall abscess	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0010 affected1,921 at risk
Abscess	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0013 affected1,921 at risk
Abscess limb	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0012 affected1,921 at risk
Anal abscess	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0013 affected1,921 at risk
Appendicitis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0005 affected1,913 at risk EG0014 affected1,921 at risk
Arthritis bacterial	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Arthritis infective	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0011 affected1,921 at risk
Bacterial pyelonephritis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Bone tuberculosis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Borrelia infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Brain abscess	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Breast abscess	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Bronchiectasis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Bronchitis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG00018 affected1,913 at risk EG00112 affected1,921 at risk
Bronchitis bacterial	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Bronchitis viral	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Bronchopneumonia	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0004 affected1,913 at risk EG0013 affected1,921 at risk
Carbuncle	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0011 affected1,921 at risk
Catheter related infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Cellulitis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG00011 affected1,913 at risk EG0019 affected1,921 at risk
Clostridial infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0011 affected1,921 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Colon gangrene	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Cystitis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0014 affected1,921 at risk
Device related infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0012 affected1,921 at risk
Diabetic foot infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0013 affected1,921 at risk
Diarrhoea infectious	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0011 affected1,921 at risk
Diverticulitis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0003 affected1,913 at risk EG0013 affected1,921 at risk
Empyema	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Erysipelas	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0008 affected1,913 at risk EG0015 affected1,921 at risk
Escherichia sepsis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Febrile infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Gallbladder empyema	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Gangrene	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0012 affected1,921 at risk
Gastroenteritis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG00017 affected1,913 at risk EG00119 affected1,921 at risk
Gastroenteritis bacterial	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Gastroenteritis viral	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Gastrointestinal infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Granuloma inguinale	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Groin abscess	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
HIV infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Hepatitis B	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Herpes zoster	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Herpes zoster ophthalmic	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0011 affected1,921 at risk
Impetigo	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Implant site infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0012 affected1,921 at risk
Infected skin ulcer	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0011 affected1,921 at risk
Infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0004 affected1,913 at risk EG0012 affected1,921 at risk
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Klebsiella infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Laryngitis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0011 affected1,921 at risk
Lobar pneumonia	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0012 affected1,921 at risk
Localised infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0012 affected1,921 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0005 affected1,913 at risk EG0018 affected1,921 at risk
Lung infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0003 affected1,913 at risk EG0018 affected1,921 at risk
Necrotising fasciitis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Osteomyelitis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0012 affected1,921 at risk
Otitis media chronic	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Parotitis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Penile abscess	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Peritonitis bacterial	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Pharyngeal abscess	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Pilonidal cyst	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Pneumonia	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG00088 affected1,913 at risk EG00172 affected1,921 at risk
Pneumonia bacterial	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Pneumonia chlamydial	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0011 affected1,921 at risk
Pneumonia legionella	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Pneumonia necrotising	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Pneumonia pneumococcal	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Pneumonia staphylococcal	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Pneumonia streptococcal	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Post procedural infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Postoperative wound infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0004 affected1,913 at risk EG0011 affected1,921 at risk
Pseudomembranous colitis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Pulmonary sepsis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0011 affected1,921 at risk
Pulmonary tuberculosis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0003 affected1,913 at risk EG0010 affected1,921 at risk
Pyelonephritis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0012 affected1,921 at risk
Pyelonephritis acute	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0010 affected1,921 at risk
Pyoderma	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Pyothorax	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Respiratory tract infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG00010 affected1,913 at risk EG00112 affected1,921 at risk
Retroperitoneal abscess	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Salmonellosis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Sepsis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG00018 affected1,913 at risk EG00120 affected1,921 at risk
Septic shock	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0007 affected1,913 at risk EG0019 affected1,921 at risk
Sinusitis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Sinusitis fungal	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Skin infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0012 affected1,921 at risk
Staphylococcal infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0012 affected1,921 at risk
Sweat gland infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Tooth abscess	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Tuberculosis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Tuberculosis bladder	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Tuberculous pleurisy	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0006 affected1,913 at risk EG0012 affected1,921 at risk
Urinary tract infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG00018 affected1,913 at risk EG00116 affected1,921 at risk
Urosepsis	Immune system disorders	MedDRA (12.0)	Systematic Assessment	EG0003 affected1,913 at risk EG0016 affected1,921 at risk
Vaginal abscess	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Vestibular neuronitis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0010 affected1,921 at risk
Viral infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0013 affected1,921 at risk
Wound abscess	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Wound infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0016 affected1,921 at risk
Wound infection bacterial	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Accident	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Accidental overdose	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0016 affected1,921 at risk
Alcohol poisoning	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0012 affected1,921 at risk
Anastomotic haemorrhage	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0003 affected1,913 at risk EG0014 affected1,921 at risk
Cataract operation complication	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0011 affected1,921 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0014 affected1,921 at risk
Coronary bypass thrombosis	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Dislocation of joint prosthesis	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0012 affected1,921 at risk
Drug dispensing error	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Drug exposure during pregnancy	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0010 affected1,921 at risk
Electric shock	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Excoriation	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Extradural haematoma	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG00011 affected1,913 at risk EG00112 affected1,921 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0005 affected1,913 at risk EG0016 affected1,921 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0006 affected1,913 at risk EG0014 affected1,921 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Foreign body trauma	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0010 affected1,921 at risk
Fracture	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Gas poisoning	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0012 affected1,921 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0004 affected1,913 at risk EG0011 affected1,921 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0012 affected1,921 at risk
Implantable defibrillator malfunction	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Injury	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0011 affected1,921 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Ligament injury	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Ligament rupture	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Limb crushing injury	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0014 affected1,921 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0003 affected1,913 at risk EG0012 affected1,921 at risk
Medical device complication	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0011 affected1,921 at risk
Meniscus lesion	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0013 affected1,921 at risk
Multiple injuries	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Muscle injury	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG00015 affected1,913 at risk EG00116 affected1,921 at risk
Pacemaker complication	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0013 affected1,921 at risk
Patella fracture	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0011 affected1,921 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0010 affected1,921 at risk
Poisoning	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0011 affected1,921 at risk
Post procedural haematuria	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0012 affected1,921 at risk
Postoperative renal failure	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0010 affected1,921 at risk
Postoperative thoracic procedure complication	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Postoperative wound complication	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Procedural complication	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0005 affected1,913 at risk EG0011 affected1,921 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0008 affected1,913 at risk EG0014 affected1,921 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0011 affected1,921 at risk
Seroma	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Skull fracture	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0003 affected1,913 at risk EG0010 affected1,921 at risk
Sternal fracture	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0012 affected1,921 at risk
Subdural haemorrhage	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Suture related complication	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Suture rupture	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0012 affected1,921 at risk
Therapeutic agent toxicity	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0012 affected1,921 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0003 affected1,913 at risk EG0012 affected1,921 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Traumatic intracranial haemorrhage	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0004 affected1,913 at risk EG0010 affected1,921 at risk
Urinary retention postoperative	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Wound	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0010 affected1,921 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Cachexia	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0006 affected1,913 at risk EG0019 affected1,921 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG00016 affected1,913 at risk EG00115 affected1,921 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0006 affected1,913 at risk EG0012 affected1,921 at risk
Diabetic foot	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0006 affected1,913 at risk EG0013 affected1,921 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0012 affected1,921 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0012 affected1,921 at risk
Folate deficiency	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Gout	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0004 affected1,913 at risk EG0014 affected1,921 at risk
Hypercreatininaemia	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0016 affected1,921 at risk
Hyperglycaemic hyperosmolar nonketotic syndrome	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG00113 affected1,921 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG00013 affected1,913 at risk EG0018 affected1,921 at risk
Hypoglycaemic seizure	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0010 affected1,921 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Hypophagia	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Hypoproteinaemia	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Lipomatosis	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0011 affected1,921 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Metabolic disorder	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Shock hypoglycaemic	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0010 affected1,921 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0013 affected1,921 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0011 affected1,921 at risk
Articular disc disorder	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Back disorder	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0006 affected1,913 at risk EG0014 affected1,921 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Chondrocalcinosis pyrophosphate	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Chondromalacia	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0010 affected1,921 at risk
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0010 affected1,921 at risk
Diabetic amyotrophy	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Fibrosis tendinous	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0012 affected1,921 at risk
Gouty arthritis	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0010 affected1,921 at risk
Gouty tophus	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0004 affected1,913 at risk EG0014 affected1,921 at risk
Joint lock	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Monarthritis	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0011 affected1,921 at risk
Muscle haemorrhage	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Muscle twitching	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0010 affected1,921 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0014 affected1,921 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0003 affected1,913 at risk EG0010 affected1,921 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0011 affected1,921 at risk
Myositis	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Neck mass	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG00015 affected1,913 at risk EG00121 affected1,921 at risk
Osteochondrosis	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Osteolysis	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0003 affected1,913 at risk EG0011 affected1,921 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Periarthritis	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Polyarthritis	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Polymyalgia rheumatica	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0011 affected1,921 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0012 affected1,921 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0011 affected1,921 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0003 affected1,913 at risk EG0010 affected1,921 at risk
Soft tissue haemorrhage	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0014 affected1,921 at risk
Spinal disorder	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0012 affected1,921 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0010 affected1,921 at risk
Abdominal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Acute leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0010 affected1,921 at risk
Adrenal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Anal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0019 affected1,921 at risk
Benign breast neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Benign pancreatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Bile duct cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0012 affected1,921 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0004 affected1,913 at risk EG0011 affected1,921 at risk
Bladder cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Bladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Bone cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Bone sarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Brain neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Brain stem glioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0003 affected1,913 at risk EG0013 affected1,921 at risk
Breast cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Breast cancer stage III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Breast cancer stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0005 affected1,913 at risk EG0013 affected1,921 at risk
Carcinoid tumour of the caecum	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Chronic myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0009 affected1,913 at risk EG0014 affected1,921 at risk
Colon cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Colon cancer stage II	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Colon neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0012 affected1,921 at risk
Desmoid tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Epiglottic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Gallbladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0008 affected1,913 at risk EG0015 affected1,921 at risk
Glioblastoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0011 affected1,921 at risk
Haemangioblastoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Hepatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Hepatic neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0012 affected1,921 at risk
Hepatic neoplasm malignant recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Hodgkin's disease recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Large cell carcinoma of the respiratory tract stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Laryngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0011 affected1,921 at risk
Leiomyosarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Lip and/or oral cavity cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Lipoma of breast	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0013 affected1,921 at risk
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG00010 affected1,913 at risk EG0013 affected1,921 at risk
Lung squamous cell carcinoma stage II	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Lung squamous cell carcinoma stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0012 affected1,921 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0011 affected1,921 at risk
Malignant neoplasm of renal pelvis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0010 affected1,921 at risk
Malignant peritoneal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0010 affected1,921 at risk
Malignant soft tissue neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Mesothelioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0011 affected1,921 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0003 affected1,913 at risk EG0012 affected1,921 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0003 affected1,913 at risk EG0012 affected1,921 at risk
Metastases to lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0003 affected1,913 at risk EG0010 affected1,921 at risk
Metastases to lymph nodes	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0012 affected1,921 at risk
Metastasis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Metastatic bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Metastatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0012 affected1,921 at risk
Metastatic squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Multiple myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0011 affected1,921 at risk
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0011 affected1,921 at risk
Nasopharyngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0005 affected1,913 at risk EG0010 affected1,921 at risk
Neoplasm prostate	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0011 affected1,921 at risk
Neoplasm skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Neuroendocrine carcinoma of the skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0012 affected1,921 at risk
Non-Hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0013 affected1,921 at risk
Non-small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0011 affected1,921 at risk
Oesophageal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Oesophageal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0014 affected1,921 at risk
Ovarian cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Ovarian germ cell teratoma benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Ovarian neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0003 affected1,913 at risk EG0011 affected1,921 at risk
Pancreatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Pituitary tumour benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Polycythaemia vera	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0012 affected1,921 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG00014 affected1,913 at risk EG00116 affected1,921 at risk
Prostate cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Prostatic adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0013 affected1,921 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0012 affected1,921 at risk
Recurrent cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Refractory anaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0011 affected1,921 at risk
Renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Small cell lung cancer stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0012 affected1,921 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0012 affected1,921 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0012 affected1,921 at risk
Superficial spreading melanoma stage III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Thymoma malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Tonsil cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Transitional cell cancer of the renal pelvis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0003 affected1,913 at risk EG0011 affected1,921 at risk
Urinary tract neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Uterine cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Waldenstrom's macroglobulinaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Altered state of consciousness	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Amyotrophic lateral sclerosis	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Aphasia	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Brain injury	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Brain oedema	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Brain stem syndrome	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0013 affected1,921 at risk
Cauda equina syndrome	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Cerebellar syndrome	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Cerebral artery embolism	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Cerebral infarction	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0003 affected1,913 at risk EG0014 affected1,921 at risk
Convulsion	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0015 affected1,921 at risk
Dementia	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0012 affected1,921 at risk
Dementia Alzheimer's type	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Diabetic hyperosmolar coma	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Dizziness	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0004 affected1,913 at risk EG0017 affected1,921 at risk
Dizziness postural	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Dysarthria	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Encephalopathy	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Epilepsy	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0012 affected1,921 at risk
Facial palsy	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Headache	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Hepatic encephalopathy	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0012 affected1,921 at risk
Hydrocephalus	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Hypercapnic encephalopathy	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Hypoglycaemic coma	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Intercostal neuralgia	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Loss of consciousness	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Metabolic encephalopathy	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Myasthenia gravis	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Nerve compression	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Orthostatic intolerance	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Paraplegia	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Parkinson's disease	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0013 affected1,921 at risk
Parkinsonism	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Phantom pain	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Polyneuropathy	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0012 affected1,921 at risk
Presyncope	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0012 affected1,921 at risk
Radicular syndrome	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Radiculopathy	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Sciatica	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0012 affected1,921 at risk
Somnolence	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0003 affected1,913 at risk EG0010 affected1,921 at risk
Spinal cord herniation	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Syncope	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG00012 affected1,913 at risk EG0015 affected1,921 at risk
Toxic encephalopathy	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0004 affected1,913 at risk EG0012 affected1,921 at risk
Trigeminal neuralgia	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Acute stress disorder	Psychiatric disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Alcohol abuse	Psychiatric disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0012 affected1,921 at risk
Alcoholism	Psychiatric disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0011 affected1,921 at risk
Anxiety	Psychiatric disorders	MedDRA (12.0)	Systematic Assessment	EG0003 affected1,913 at risk EG0012 affected1,921 at risk
Bipolar I disorder	Psychiatric disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Confusional state	Psychiatric disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0011 affected1,921 at risk
Delusion	Psychiatric disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Depression	Psychiatric disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0013 affected1,921 at risk
Disorientation	Psychiatric disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Hallucination	Psychiatric disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0011 affected1,921 at risk
Mental disorder	Psychiatric disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0012 affected1,921 at risk
Personality disorder	Psychiatric disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Psychotic disorder	Psychiatric disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0012 affected1,921 at risk
Reactive psychosis	Psychiatric disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0010 affected1,921 at risk
Schizophrenia	Psychiatric disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Sleep disorder	Psychiatric disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Suicide attempt	Psychiatric disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Acute prerenal failure	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0012 affected1,921 at risk
Anuria	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0011 affected1,921 at risk
Azotaemia	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0011 affected1,921 at risk
Calculus bladder	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Calculus ureteric	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0005 affected1,913 at risk EG0013 affected1,921 at risk
Diabetic nephropathy	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Glomerulonephritis chronic	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Haematuria	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0005 affected1,913 at risk EG0015 affected1,921 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0013 affected1,921 at risk
Hypertensive nephropathy	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Nephritis allergic	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0012 affected1,921 at risk
Nephrotic syndrome	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Obstructive uropathy	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0012 affected1,921 at risk
Renal artery stenosis	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Renal failure	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG00033 affected1,913 at risk EG00143 affected1,921 at risk
Renal failure acute	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG00021 affected1,913 at risk EG00121 affected1,921 at risk
Renal failure chronic	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0007 affected1,913 at risk EG0016 affected1,921 at risk
Renal impairment	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0004 affected1,913 at risk EG0019 affected1,921 at risk
Renal mass	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Stress urinary incontinence	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Urethral haemorrhage	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Urethral meatus stenosis	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Urethral stenosis	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0011 affected1,921 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Urinary retention	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0006 affected1,913 at risk EG0017 affected1,921 at risk
Urinary tract disorder	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Urinary tract inflammation	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Adnexa uteri cyst	Reproductive system and breast disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA (12.0)	Systematic Assessment	EG0008 affected1,913 at risk EG00111 affected1,921 at risk
Breast mass	Reproductive system and breast disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0011 affected1,921 at risk
Endometrial hyperplasia	Reproductive system and breast disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Female genital tract fistula	Reproductive system and breast disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Genital ulceration	Reproductive system and breast disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Hydrometra	Reproductive system and breast disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Menorrhagia	Reproductive system and breast disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Ovarian cyst torsion	Reproductive system and breast disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Perineal fistula	Reproductive system and breast disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Prostatic haemorrhage	Reproductive system and breast disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0010 affected1,921 at risk
Prostatism	Reproductive system and breast disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0012 affected1,921 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0012 affected1,921 at risk
Testicular haemorrhage	Reproductive system and breast disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Uterine disorder	Reproductive system and breast disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Uterine polyp	Reproductive system and breast disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Vaginal prolapse	Reproductive system and breast disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0006 affected1,913 at risk EG0010 affected1,921 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0011 affected1,921 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0011 affected1,921 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0006 affected1,913 at risk EG0017 affected1,921 at risk
Asthmatic crisis	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Bronchitis chronic	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0003 affected1,913 at risk EG0013 affected1,921 at risk
Bullous lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG00026 affected1,913 at risk EG00128 affected1,921 at risk
Chronic respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0007 affected1,913 at risk EG0012 affected1,921 at risk
Emphysema	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0010 affected1,921 at risk
Epiglottic cyst	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0005 affected1,913 at risk EG0013 affected1,921 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0011 affected1,921 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Hypercapnia	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Idiopathic pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Middle lobe syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0013 affected1,921 at risk
Pneumomediastinum	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0013 affected1,921 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0013 affected1,921 at risk
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0012 affected1,921 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Respiratory acidosis	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0011 affected1,921 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0007 affected1,913 at risk EG0015 affected1,921 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0014 affected1,921 at risk
Status asthmaticus	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Tracheal stenosis	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Vocal cord polyp	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Wegener's granulomatosis	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Actinic keratosis	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Cutaneous vasculitis	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0011 affected1,921 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0010 affected1,921 at risk
Dermatitis exfoliative	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Diabetic bullosis	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Diabetic ulcer	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Erythema multiforme	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Erythema nodosum	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0011 affected1,921 at risk
Ingrowing nail	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Leukocytoclastic vasculitis	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0011 affected1,921 at risk
Nodular vasculitis	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Skin exfoliation	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Skin fissures	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Skin necrosis	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0012 affected1,921 at risk
Stevens-Johnson syndrome	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Toxic skin eruption	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Aortic aneurysm	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Arteriosclerosis obliterans	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Bleeding varicose vein	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0003 affected1,913 at risk EG0012 affected1,921 at risk
Diabetic macroangiopathy	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0012 affected1,921 at risk
Extremity necrosis	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0011 affected1,921 at risk
Haematoma	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0006 affected1,913 at risk EG0014 affected1,921 at risk
Haemorrhage	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0012 affected1,921 at risk
Hot flush	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Hypertension	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected1,913 at risk EG0011 affected1,921 at risk
Hypotension	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0004 affected1,913 at risk EG0014 affected1,921 at risk
Hypovolaemic shock	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0005 affected1,913 at risk EG0012 affected1,921 at risk
Intermittent claudication	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0011 affected1,921 at risk
Ischaemic limb pain	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Orthostatic hypotension	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk
Peripheral embolism	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Peripheral ischaemia	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0011 affected1,921 at risk
Phlebitis superficial	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Shock	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0013 affected1,921 at risk
Shock haemorrhagic	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0005 affected1,913 at risk EG0010 affected1,921 at risk
Temporal arteritis	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0011 affected1,921 at risk
Thrombophlebitis	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected1,913 at risk EG0012 affected1,921 at risk
Varicose ulceration	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0012 affected1,921 at risk
Vasculitis	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected1,913 at risk EG0010 affected1,921 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (12.0)	Systematic Assessment	EG00078 affected1,913 at risk EG001108 affected1,921 at risk
Angina pectoris	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG000100 affected1,913 at risk EG001100 affected1,921 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG000123 affected1,913 at risk EG001130 affected1,921 at risk
Cardiac failure	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG000231 affected1,913 at risk EG001200 affected1,921 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG000106 affected1,913 at risk EG00192 affected1,921 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG000136 affected1,913 at risk EG001159 affected1,921 at risk
Gastritis	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG00098 affected1,913 at risk EG00182 affected1,921 at risk
Blood creatinine increased	General disorders	MedDRA (12.0)	Systematic Assessment	EG000163 affected1,913 at risk EG001285 affected1,921 at risk
Blood glucose increased	General disorders	MedDRA (12.0)	Systematic Assessment	EG000153 affected1,913 at risk EG001154 affected1,921 at risk
Blood potassium increased	General disorders	MedDRA (12.0)	Systematic Assessment	EG000111 affected1,913 at risk EG001161 affected1,921 at risk
Blood urea increased	General disorders	MedDRA (12.0)	Systematic Assessment	EG000159 affected1,913 at risk EG001222 affected1,921 at risk
Blood uric acid increased	General disorders	MedDRA (12.0)	Systematic Assessment	EG000150 affected1,913 at risk EG001167 affected1,921 at risk
Chest pain	General disorders	MedDRA (12.0)	Systematic Assessment	EG000119 affected1,913 at risk EG001109 affected1,921 at risk
Bronchitis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG000231 affected1,913 at risk EG001222 affected1,921 at risk
Influenza	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG000111 affected1,913 at risk EG001116 affected1,921 at risk
Nasopharyngitis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG000170 affected1,913 at risk EG001195 affected1,921 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG00090 affected1,913 at risk EG001107 affected1,921 at risk
Urinary tract infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG000119 affected1,913 at risk EG001119 affected1,921 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG000160 affected1,913 at risk EG001160 affected1,921 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG000135 affected1,913 at risk EG001121 affected1,921 at risk
Dizziness	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG000254 affected1,913 at risk EG001245 affected1,921 at risk
Headache	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG000116 affected1,913 at risk EG001100 affected1,921 at risk
Renal failure	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG00095 affected1,913 at risk EG001132 affected1,921 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG000179 affected1,913 at risk EG001170 affected1,921 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG000166 affected1,913 at risk EG001152 affected1,921 at risk
Hypertension	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG000147 affected1,913 at risk EG001123 affected1,921 at risk
Hypotension	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG000127 affected1,913 at risk EG001178 affected1,921 at risk

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

ID	Term
D001713	Biphenyl Compounds
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D013777	Tetrazoles

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Losartan 50 mg				691	1,913	1,358	1,913
EG001	Losartan 150 mg				710	1,921	1,394	1,921