Comparison Trial of Letrozole to Anastrozole in the Adjuv... | NCT00248170

ID	Type	Description	Link
2005-004263-35	EudraCT Number
EUDRACT number 2005-004263-35	Registry Identifier	EUDRACT

Label	Type	Description	Intervention Names
Letrozole	Experimental	2.5 mg by mouth (p.o.) once daily	Drug: Letrozole
Anastrozole	Active Comparator	1 mg p.o. once daily	Drug: Anastrozole

Name	Type	Description	Arm Group Labels	Other Names
Letrozole	Drug	2.5 mg tablets	Letrozole
Anastrozole

Measure	Description	Time Frame
Disease Free Survival	Disease-free survival was defined as the time from the date of randomization to the date of the first documentation of re-occurrence of invasive breast cancer in local, regional or distant sites, new invasive breast cancer in the contra-lateral breast, or death from any cause.	84 months

Measure	Description	Time Frame
Overall Survival	Overall survival was defined as the time from the date of randomization to the date of death from any cause.	84 months
Time to Development of Distant Metastases	Time to development of distant metastases was defined as the time from date of randomization to the date of the first development of any recurrent or metastatic disease in sites other than the local mastectomy scar, the ipsilateral breast in case of breast conservation or the contra lateral breast.

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Birmingham Hematology and Oncology Associates		Birmingham	Alabama	35205	United States
Comprehensive Cancer Institute

ID	Title	Description
FG000	Letrozole	2.5 mg by mouth (p.o.) once daily
FG001	Anastrozole	1 mg p.o. once daily

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

Disease Free Survival

Disease-free survival was defined as the time from the date of randomization to the date of the first documentation of re-occurrence of invasive breast cancer in local, regional or distant sites, new invasive breast cancer in the contra-lateral breast, or death from any cause.

Intent-to-treat (ITT) - the ITT contained randomized participants who had no protocol deviations.

Posted

Median

95% Confidence Interval

Months

84 months

ID	Title	Description
OG000	Letrozole	2.5 mg by mouth (p.o.) once daily
OG001	Anastrozole	1 mg p.o. once daily

Units	Counts
Participants	OG0002061 OG0012075

Title

Denominators

Categories

Title	Measurements
	OG000NA(84.14 to NA)The median was not reached and therefore, could not be calculated. OG001NA(NA to NA)The median was not reached and therefore, could not be calculated.

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		Log Rank		0.3150													No	Superiority or Other

Secondary

Overall Survival

Overall survival was defined as the time from the date of randomization to the date of death from any cause.

Intent-to-treat (ITT) - the ITT contained randomized participants who had no protocol deviations.

Posted

Median

95% Confidence Interval

Months

84 months

ID	Title	Description
OG000	Letrozole	2.5 mg by mouth (p.o.) once daily
OG001	Anastrozole	1 mg p.o. once daily

Units	Counts
Participants	OG000

Secondary

Time to Development of Distant Metastases

Time to development of distant metastases was defined as the time from date of randomization to the date of the first development of any recurrent or metastatic disease in sites other than the local mastectomy scar, the ipsilateral breast in case of breast conservation or the contra lateral breast.

Intent-to-treat (ITT) - the ITT contained randomized participants who had no protocol deviations.

Posted

Median

95% Confidence Interval

Months

84 months

ID	Title	Description
OG000	Letrozole	2.5 mg by mouth (p.o.) once daily
OG001	Anastrozole	1 mg p.o. once daily

Units	Counts
Participants	OG000

Secondary

Time to Development of Contra Lateral Breast Cancer

Time to development of contra lateral breast cancer was defined as the time from the date of randomization to the date of the first development of any disease in the contra lateral breast.

Intent-to-treat (ITT) - the ITT contained randomized participants who had no protocol deviations.

Posted

Median

95% Confidence Interval

Months

84 months

ID	Title	Description
OG000	Letrozole	2.5 mg by mouth (p.o.) once daily
OG001	Anastrozole	1 mg p.o. once daily

Units	Counts
Participants	OG000

Secondary

Distant Disease-free Survival

Distant disease-free survival was defined as the time from date of randomization to the date of the first development of any relapse at a distant site or death from any cause.

Intent-to-treat (ITT) - the ITT contained randomized participants who had no protocol deviations.

Posted

Median

95% Confidence Interval

Months

84 months

ID	Title	Description
OG000	Letrozole	2.5 mg by mouth (p.o.) once daily
OG001	Anastrozole	1 mg p.o. once daily

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Serum Lipid Profiles

Total cholesterol was analyzed to assess the impact on serum lipids profiles. The adjusted means was calculated.

Safety Set: The safety set included randomized participants who received at least one of study medication and had at least one post baseline assessment.

Posted

Mean

95% Confidence Interval

mg/dL

baseline, 6, 12, 24, 36, 48 and 60 months

ID	Title	Description
OG000	Letrozole	2.5 mg by mouth (p.o.) once daily
OG001	Anastrozole	1 mg p.o. once daily

Units	Counts
Participants	OG000

Secondary

Percentage of Participants Who Experienced Clinical Fracture Events

The incidence of clinical fractures was analyzed.

Safety Set: The safety set included randomized participants who received at least one of study medication and had at least one post baseline assessment.

Posted

Number

Percentage of participants

84 months

ID	Title	Description
OG000	Letrozole	2.5 mg by mouth (p.o.) once daily
OG001	Anastrozole	1 mg p.o. once daily

Units	Counts
Participants	OG000

Secondary

Percentage of Participants Who Experienced Cardiovascular Events

The incidence of ischemic heart disease, cardiac failures, cerebrovascular accidents and thromboembolic events was analyzed.

Safety Set: The safety set included randomized participants who received at least one of study medication and had at least one post baseline assessment.

Posted

Number

Percentage of participants

84 months

ID	Title	Description
OG000	Letrozole	2.5 mg by mouth (p.o.) once daily
OG001	Anastrozole	1 mg p.o. once daily

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0004 affected2,049 at risk EG0013 affected2,062 at risk
Autoimmune haemolytic anaemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0012 affected2,062 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0011 affected2,062 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA	Systematic Assessment	EG0003 affected2,049 at risk EG0014 affected2,062 at risk
Adams-Stokes syndrome	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Angina pectoris	Cardiac disorders	MedDRA	Systematic Assessment	EG0008 affected2,049 at risk EG0018 affected2,062 at risk
Angina unstable	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0012 affected2,062 at risk
Arrhythmia	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0012 affected2,062 at risk
Atrial fibrillation	Cardiac disorders	MedDRA	Systematic Assessment	EG00019 affected2,049 at risk EG00115 affected2,062 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Bradycardia	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0011 affected2,062 at risk
Bundle branch block	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Cardiac arrest	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0014 affected2,062 at risk
Cardiac disorder	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0011 affected2,062 at risk
Cardiac failure	Cardiac disorders	MedDRA	Systematic Assessment	EG0009 affected2,049 at risk EG0013 affected2,062 at risk
Cardiac failure acute	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA	Systematic Assessment	EG0003 affected2,049 at risk EG0010 affected2,062 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA	Systematic Assessment	EG0009 affected2,049 at risk EG0014 affected2,062 at risk
Cardiac fibrillation	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0012 affected2,062 at risk
Cardiac tamponade	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Cardiac valve disease	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0012 affected2,062 at risk
Cardiomyopathy	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0011 affected2,062 at risk
Cardiovascular insufficiency	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Conduction disorder	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Congestive cardiomyopathy	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Cor pulmonale	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Coronary artery disease	Cardiac disorders	MedDRA	Systematic Assessment	EG0007 affected2,049 at risk EG0012 affected2,062 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0010 affected2,062 at risk
Gastrocardiac syndrome	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Left ventricular dysfunction	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0011 affected2,062 at risk
Left ventricular failure	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Mitral valve disease	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Myocardial infarction	Cardiac disorders	MedDRA	Systematic Assessment	EG0005 affected2,049 at risk EG0014 affected2,062 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0012 affected2,062 at risk
Palpitations	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0011 affected2,062 at risk
Restrictive cardiomyopathy	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Sick sinus syndrome	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Stress cardiomyopathy	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0010 affected2,062 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0010 affected2,062 at risk
Tachyarrhythmia	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Tachycardia	Cardiac disorders	MedDRA	Systematic Assessment	EG0003 affected2,049 at risk EG0010 affected2,062 at risk
Tricuspid valve incompetence	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0011 affected2,062 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0012 affected2,062 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Atrial septal defect	Congenital, familial and genetic disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Syndactyly	Congenital, familial and genetic disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Vitello-intestinal duct remnant	Congenital, familial and genetic disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Hearing impaired	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Inner ear disorder	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Tympanic membrane perforation	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Vertigo	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0008 affected2,049 at risk EG0011 affected2,062 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0012 affected2,062 at risk
Autoimmune thyroiditis	Endocrine disorders	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0010 affected2,062 at risk
Goitre	Endocrine disorders	MedDRA	Systematic Assessment	EG0004 affected2,049 at risk EG0012 affected2,062 at risk
Hyperparathyroidism	Endocrine disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0013 affected2,062 at risk
Hypothyroidism	Endocrine disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Toxic nodular goitre	Endocrine disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0011 affected2,062 at risk
Cataract	Eye disorders	MedDRA	Systematic Assessment	EG0009 affected2,049 at risk EG0012 affected2,062 at risk
Dacryostenosis acquired	Eye disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Diplopia	Eye disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Glaucoma	Eye disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0011 affected2,062 at risk
Lens dislocation	Eye disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Macular hole	Eye disorders	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0011 affected2,062 at risk
Open angle glaucoma	Eye disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Retinal detachment	Eye disorders	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0010 affected2,062 at risk
Retinal vein thrombosis	Eye disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Vision blurred	Eye disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Abdominal adhesions	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0012 affected2,062 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0011 affected2,062 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0011 affected2,062 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0009 affected2,049 at risk EG0015 affected2,062 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0013 affected2,062 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0006 affected2,049 at risk EG0017 affected2,062 at risk
Abdominal wall haematoma	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Anal sphincter atony	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Ascites	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Colitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0011 affected2,062 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0012 affected2,062 at risk
Colitis microscopic	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Colitis ulcerative	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Constipation	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0013 affected2,062 at risk
Crohn's disease	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0008 affected2,049 at risk EG0015 affected2,062 at risk
Diverticulum	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Diverticulum intestinal	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0011 affected2,062 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0011 affected2,062 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Dysphagia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Enterocutaneous fistula	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Enterovesical fistula	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0012 affected2,062 at risk
Faecal incontinence	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Faeces discoloured	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Femoral hernia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Gastric polyps	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0012 affected2,062 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Gastric ulcer perforation	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Gastritis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0003 affected2,049 at risk EG0015 affected2,062 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0010 affected2,062 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0011 affected2,062 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0013 affected2,062 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Haematemesis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0013 affected2,062 at risk
Haematochezia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0011 affected2,062 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0011 affected2,062 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0010 affected2,062 at risk
Ileus	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0003 affected2,049 at risk EG0013 affected2,062 at risk
Ileus paralytic	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Inflammatory bowel disease	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0011 affected2,062 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0012 affected2,062 at risk
Intestinal dilatation	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0003 affected2,049 at risk EG0012 affected2,062 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Intestinal polyp	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0007 affected2,049 at risk EG0012 affected2,062 at risk
Melaena	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Mouth cyst	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Nausea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00011 affected2,049 at risk EG0016 affected2,062 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0011 affected2,062 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0012 affected2,062 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0015 affected2,062 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0013 affected2,062 at risk
Spigelian hernia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Stomatitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0010 affected2,062 at risk
Subileus	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0012 affected2,062 at risk
Tooth loss	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0011 affected2,062 at risk
Volvulus	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Vomiting	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00011 affected2,049 at risk EG0016 affected2,062 at risk
Asthenia	General disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0016 affected2,062 at risk
Cardiac death	General disorders	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0010 affected2,062 at risk
Chest discomfort	General disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Chest pain	General disorders	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0011 affected2,062 at risk
Death	General disorders	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0012 affected2,062 at risk
Device damage	General disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Device dislocation	General disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0012 affected2,062 at risk
Device malfunction	General disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Disease progression	General disorders	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0012 affected2,062 at risk
Disease recurrence	General disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Drowning	General disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Fat necrosis	General disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0012 affected2,062 at risk
Fatigue	General disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0012 affected2,062 at risk
Gait disturbance	General disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0012 affected2,062 at risk
General physical health deterioration	General disorders	MedDRA	Systematic Assessment	EG0004 affected2,049 at risk EG0013 affected2,062 at risk
Impaired healing	General disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0011 affected2,062 at risk
Implant site extravasation	General disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Injection site phlebitis	General disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Malaise	General disorders	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0013 affected2,062 at risk
Multi-organ failure	General disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0011 affected2,062 at risk
Non-cardiac chest pain	General disorders	MedDRA	Systematic Assessment	EG0003 affected2,049 at risk EG0012 affected2,062 at risk
Oedema peripheral	General disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Pain	General disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0012 affected2,062 at risk
Patient-device incompatibility	General disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Pyrexia	General disorders	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0018 affected2,062 at risk
Sudden death	General disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Thrombosis in device	General disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Biliary colic	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0007 affected2,049 at risk EG0015 affected2,062 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0010 affected2,062 at risk
Cholecystitis chronic	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0008 affected2,049 at risk EG00111 affected2,062 at risk
Cholestasis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Gallbladder perforation	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Gallbladder polyp	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0011 affected2,062 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Hepatic steatosis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0010 affected2,062 at risk
Liver disorder	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Anaphylactic shock	Immune system disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Drug hypersensitivity	Immune system disorders	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0011 affected2,062 at risk
Hypersensitivity	Immune system disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Sarcoidosis	Immune system disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Abdominal abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Abscess limb	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Abscess neck	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Abscess soft tissue	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Anal abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Appendicitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0015 affected2,062 at risk
Appendicitis perforated	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Arthritis bacterial	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0010 affected2,062 at risk
Arthritis infective	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0012 affected2,062 at risk
Breast abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0011 affected2,062 at risk
Breast cellulitis	Infections and infestations	MedDRA	Systematic Assessment	EG0006 affected2,049 at risk EG0014 affected2,062 at risk
Bronchitis	Infections and infestations	MedDRA	Systematic Assessment	EG0003 affected2,049 at risk EG0014 affected2,062 at risk
Bronchopneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0012 affected2,062 at risk
Cellulitis	Infections and infestations	MedDRA	Systematic Assessment	EG0008 affected2,049 at risk EG0019 affected2,062 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA	Systematic Assessment	EG0003 affected2,049 at risk EG0013 affected2,062 at risk
Cystitis	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0013 affected2,062 at risk
Device related infection	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0011 affected2,062 at risk
Diverticulitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0017 affected2,062 at risk
Encephalitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Endocarditis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Erysipelas	Infections and infestations	MedDRA	Systematic Assessment	EG0005 affected2,049 at risk EG0018 affected2,062 at risk
Escherichia sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Gallbladder empyema	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Gangrene	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Gastroenteritis	Infections and infestations	MedDRA	Systematic Assessment	EG0007 affected2,049 at risk EG0012 affected2,062 at risk
Gastroenteritis Escherichia coli	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Gastroenteritis norovirus	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0011 affected2,062 at risk
Helicobacter infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Herpes zoster	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0012 affected2,062 at risk
Incision site abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Infected skin ulcer	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0013 affected2,062 at risk
Influenza	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0010 affected2,062 at risk
Laryngitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Lobar pneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Localised infection	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0011 affected2,062 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0014 affected2,062 at risk
Lymphangitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Mastitis	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0015 affected2,062 at risk
Meningitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Nosocomial infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Oral candidiasis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Osteomyelitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Otitis media	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Periorbital cellulitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Peritonitis	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0012 affected2,062 at risk
Pharyngeal abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Pilonidal cyst	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Pneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG00016 affected2,049 at risk EG00129 affected2,062 at risk
Pneumonia klebsiella	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Pneumonia legionella	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Post procedural cellulitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Post procedural pneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Postoperative wound infection	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0012 affected2,062 at risk
Pseudomembranous colitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0011 affected2,062 at risk
Pseudomonas bronchitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Pyelonephritis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0012 affected2,062 at risk
Pyelonephritis acute	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Pyometra	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0003 affected2,049 at risk EG0013 affected2,062 at risk
Sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0003 affected2,049 at risk EG0018 affected2,062 at risk
Septic shock	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Skin infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0013 affected2,062 at risk
Soft tissue infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Staphylococcal infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Urinary tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0007 affected2,049 at risk EG0018 affected2,062 at risk
Urosepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0003 affected2,049 at risk EG0013 affected2,062 at risk
Vaginal infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Vestibular neuronitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Viral diarrhoea	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Viral infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Vulvitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Wound infection	Infections and infestations	MedDRA	Systematic Assessment	EG0003 affected2,049 at risk EG0011 affected2,062 at risk
Acetabulum fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Alcohol poisoning	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG00014 affected2,049 at risk EG00110 affected2,062 at risk
Arthropod bite	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Brain contusion	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0012 affected2,062 at risk
Compression fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0011 affected2,062 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Dislocation of vertebra	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Excoriation	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Face injury	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0012 affected2,062 at risk
Fall	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG00017 affected2,049 at risk EG00113 affected2,062 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0003 affected2,049 at risk EG0013 affected2,062 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0008 affected2,049 at risk EG0012 affected2,062 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0003 affected2,049 at risk EG0012 affected2,062 at risk
Forearm fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0011 affected2,062 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0005 affected2,049 at risk EG0014 affected2,062 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0009 affected2,049 at risk EG0016 affected2,062 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0012 affected2,062 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0011 affected2,062 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0011 affected2,062 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0012 affected2,062 at risk
Ligament rupture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0003 affected2,049 at risk EG0012 affected2,062 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0004 affected2,049 at risk EG0014 affected2,062 at risk
Meniscus injury	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0014 affected2,062 at risk
Multiple fractures	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0003 affected2,049 at risk EG0013 affected2,062 at risk
Muscle rupture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0013 affected2,062 at risk
Patella fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0011 affected2,062 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0003 affected2,049 at risk EG0010 affected2,062 at risk
Pneumothorax traumatic	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Post procedural complication	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0012 affected2,062 at risk
Post procedural hypothyroidism	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Postoperative hernia	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Postoperative wound complication	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0010 affected2,062 at risk
Pubis fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0012 affected2,062 at risk
Pulmonary contusion	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Radiation pericarditis	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Radiation pneumonitis	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0012 affected2,062 at risk
Radiation skin injury	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0012 affected2,062 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0017 affected2,062 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0003 affected2,049 at risk EG0011 affected2,062 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Seroma	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0014 affected2,062 at risk
Skull fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0011 affected2,062 at risk
Soft tissue injury	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0006 affected2,049 at risk EG0012 affected2,062 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0011 affected2,062 at risk
Splenic rupture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Sternal fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0003 affected2,049 at risk EG0012 affected2,062 at risk
Subdural haemorrhage	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0011 affected2,062 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0003 affected2,049 at risk EG0010 affected2,062 at risk
Tracheal injury	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Ulna fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0011 affected2,062 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0003 affected2,049 at risk EG0015 affected2,062 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0012 affected2,062 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0006 affected2,049 at risk EG0013 affected2,062 at risk
Amylase increased	Investigations	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Aspiration pleural cavity	Investigations	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Biopsy breast	Investigations	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0012 affected2,062 at risk
Biopsy lymph gland	Investigations	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Bone density decreased	Investigations	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Carbohydrate antigen 15-3 increased	Investigations	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Clostridium test positive	Investigations	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Fibrin D dimer increased	Investigations	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Haemoglobin decreased	Investigations	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
International normalised ratio increased	Investigations	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0011 affected2,062 at risk
Lipase increased	Investigations	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Mammogram abnormal	Investigations	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Mediastinal biopsy	Investigations	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Weight decreased	Investigations	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0010 affected2,062 at risk
Weight increased	Investigations	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0007 affected2,049 at risk EG0011 affected2,062 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0010 affected2,062 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0004 affected2,049 at risk EG0012 affected2,062 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0010 affected2,062 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0004 affected2,049 at risk EG0010 affected2,062 at risk
Hypophagia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0011 affected2,062 at risk
Obesity	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0009 affected2,049 at risk EG0016 affected2,062 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0019 affected2,062 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0006 affected2,049 at risk EG00110 affected2,062 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0012 affected2,062 at risk
Compartment syndrome	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0011 affected2,062 at risk
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0012 affected2,062 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0016 affected2,062 at risk
Joint instability	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Joint stiffness	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Kyphosis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Loose body in joint	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0011 affected2,062 at risk
Muscle atrophy	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0011 affected2,062 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0003 affected2,049 at risk EG0014 affected2,062 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0013 affected2,062 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0011 affected2,062 at risk
Myopathy	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00021 affected2,049 at risk EG00115 affected2,062 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Osteopenia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0011 affected2,062 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0003 affected2,049 at risk EG0011 affected2,062 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0010 affected2,062 at risk
Polyarthritis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Pseudarthrosis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0012 affected2,062 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0004 affected2,049 at risk EG0011 affected2,062 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0012 affected2,062 at risk
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0010 affected2,062 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0010 affected2,062 at risk
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Synovitis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Tenosynovitis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Trigger finger	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0011 affected2,062 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0011 affected2,062 at risk
Adenocarcinoma of the cervix	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Angiomyolipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Benign laryngeal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Benign lymph node neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Benign neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Benign neoplasm of thyroid gland	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0013 affected2,062 at risk
Benign salivary gland neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Bone cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Brain neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0011 affected2,062 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0011 affected2,062 at risk
Colon neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Diffuse large B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Fibroma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0011 affected2,062 at risk
Fibromatosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Gallbladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0010 affected2,062 at risk
Gastrointestinal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Gastrointestinal tract adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Glioblastoma multiforme	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Haemangioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Hepatic cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Lip and/or oral cavity cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Lip neoplasm benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0011 affected2,062 at risk
Lymphangiosis carcinomatosa	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Malignant melanoma in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0011 affected2,062 at risk
Malignant peritoneal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Malignant pleural effusion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0011 affected2,062 at risk
Metastases to abdominal cavity	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0011 affected2,062 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Metastases to peritoneum	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Metastatic pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Neurilemmoma benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Ovarian cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Ovarian cancer stage III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0010 affected2,062 at risk
Ovarian fibroma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Ovarian neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0012 affected2,062 at risk
Pituitary tumour benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0012 affected2,062 at risk
Pleomorphic adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Rectal adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Rectosigmoid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Retro-orbital neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Salivary gland neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Schwannoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Seborrhoeic keratosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Signet-ring cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0014 affected2,062 at risk
Superficial spreading melanoma stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Thyroid adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0010 affected2,062 at risk
Thyroid neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0003 affected2,049 at risk EG0011 affected2,062 at risk
Waldenstrom's macroglobulinaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Amnesia	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0011 affected2,062 at risk
Ataxia	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Balance disorder	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0016 affected2,062 at risk
Cerebral amyloid angiopathy	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Cerebral infarction	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0016 affected2,062 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0010 affected2,062 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA	Systematic Assessment	EG0008 affected2,049 at risk EG0015 affected2,062 at risk
Cervicobrachial syndrome	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Convulsion	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0013 affected2,062 at risk
Dementia	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0011 affected2,062 at risk
Dementia Alzheimer's type	Nervous system disorders	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0010 affected2,062 at risk
Dizziness	Nervous system disorders	MedDRA	Systematic Assessment	EG0003 affected2,049 at risk EG0016 affected2,062 at risk
Dysarthria	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0012 affected2,062 at risk
Encephalopathy	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0011 affected2,062 at risk
Epilepsy	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Facial paresis	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0010 affected2,062 at risk
Headache	Nervous system disorders	MedDRA	Systematic Assessment	EG0003 affected2,049 at risk EG0014 affected2,062 at risk
Hepatic encephalopathy	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Horner's syndrome	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Hypoaesthesia	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0011 affected2,062 at risk
Hypogeusia	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Intracranial aneurysm	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0012 affected2,062 at risk
Ischaemic stroke	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Lumbar radiculopathy	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Monoplegia	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Multiple sclerosis	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Multiple sclerosis relapse	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Myasthenia gravis	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Optic neuritis	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Parkinsonism	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Partial seizures	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Petit mal epilepsy	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Presyncope	Nervous system disorders	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0010 affected2,062 at risk
Sciatica	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0012 affected2,062 at risk
Sensory loss	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Speech disorder	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Spinal claudication	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Spinal epidural haemorrhage	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA	Systematic Assessment	EG0003 affected2,049 at risk EG0014 affected2,062 at risk
Syncope	Nervous system disorders	MedDRA	Systematic Assessment	EG00013 affected2,049 at risk EG0014 affected2,062 at risk
Tardive dyskinesia	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Transient global amnesia	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0011 affected2,062 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA	Systematic Assessment	EG0008 affected2,049 at risk EG0015 affected2,062 at risk
Tremor	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Trigeminal neuralgia	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
VIIth nerve paralysis	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0012 affected2,062 at risk
Vertebrobasilar insufficiency	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Abnormal behaviour	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Agitation	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Anxiety	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Completed suicide	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Confusional state	Psychiatric disorders	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0018 affected2,062 at risk
Delirium	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Depressed mood	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0013 affected2,062 at risk
Depression	Psychiatric disorders	MedDRA	Systematic Assessment	EG0009 affected2,049 at risk EG00111 affected2,062 at risk
Drug dependence	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Intentional self-injury	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Major depression	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0011 affected2,062 at risk
Mental disorder	Psychiatric disorders	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0010 affected2,062 at risk
Mental status changes	Psychiatric disorders	MedDRA	Systematic Assessment	EG0003 affected2,049 at risk EG0012 affected2,062 at risk
Mood disorder due to a general medical condition	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Mood swings	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Somatisation disorder	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Suicide attempt	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0011 affected2,062 at risk
Calculus bladder	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Calculus ureteric	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Calculus urinary	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0011 affected2,062 at risk
Haematuria	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0013 affected2,062 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0011 affected2,062 at risk
Hypertonic bladder	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0012 affected2,062 at risk
Nephrotic syndrome	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Polyuria	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Renal colic	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0011 affected2,062 at risk
Renal failure	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0017 affected2,062 at risk
Renal failure acute	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0006 affected2,049 at risk EG0012 affected2,062 at risk
Renal failure chronic	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Renal impairment	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Stress urinary incontinence	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Urethral caruncle	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Urethral obstruction	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0014 affected2,062 at risk
Urinary tract obstruction	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Adnexa uteri mass	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Anisomastia	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Breast calcifications	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Breast fibrosis	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0012 affected2,062 at risk
Breast haematoma	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0011 affected2,062 at risk
Breast inflammation	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0012 affected2,062 at risk
Breast mass	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0012 affected2,062 at risk
Breast oedema	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Colpocele	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Cystocele	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0011 affected2,062 at risk
Endometrial hyperplasia	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Female genital tract fistula	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0011 affected2,062 at risk
Genital prolapse	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Metrorrhagia	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Nipple disorder	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Nipple exudate bloody	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0005 affected2,049 at risk EG0013 affected2,062 at risk
Pelvic prolapse	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Perineal pain	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Rectocele	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0012 affected2,062 at risk
Uterine fistula	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Uterine polyp	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0011 affected2,062 at risk
Uterine prolapse	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0011 affected2,062 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0012 affected2,062 at risk
Vaginal inflammation	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Vaginal prolapse	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0012 affected2,062 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0013 affected2,062 at risk
Bronchial hyperreactivity	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Choking	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0006 affected2,049 at risk EG0019 affected2,062 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG00010 affected2,049 at risk EG0017 affected2,062 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Emphysema	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0011 affected2,062 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0012 affected2,062 at risk
Hypercapnia	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0011 affected2,062 at risk
Idiopathic pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0012 affected2,062 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0005 affected2,049 at risk EG0013 affected2,062 at risk
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0010 affected2,062 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0003 affected2,049 at risk EG0013 affected2,062 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0006 affected2,049 at risk EG00112 affected2,062 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0011 affected2,062 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0010 affected2,062 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0010 affected2,062 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0003 affected2,049 at risk EG0013 affected2,062 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Dermal cyst	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Erythema multiforme	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0010 affected2,062 at risk
Erythrodermic psoriasis	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Hypertrophic scar	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Keloid scar	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Skin necrosis	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Urticaria chronic	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Breast lump removal	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Breast operation	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Breast prosthesis implantation	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0005 affected2,049 at risk EG00110 affected2,062 at risk
Breast prosthesis removal	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0011 affected2,062 at risk
Breast reconstruction	Surgical and medical procedures	MedDRA	Systematic Assessment	EG00024 affected2,049 at risk EG00116 affected2,062 at risk
Central venous catheter removal	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Knee arthroplasty	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Mammoplasty	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0006 affected2,049 at risk EG0013 affected2,062 at risk
Mastectomy	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0005 affected2,049 at risk EG0016 affected2,062 at risk
Mechanical ventilation	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Medical device removal	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Meniscus removal	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Modified radical mastectomy	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Removal of internal fixation	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Scar excision	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0012 affected2,062 at risk
Spinal laminectomy	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Wound treatment	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Aortic aneurysm	Vascular disorders	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0011 affected2,062 at risk
Aortic aneurysm rupture	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Aortic dissection	Vascular disorders	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0011 affected2,062 at risk
Aortic stenosis	Vascular disorders	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0011 affected2,062 at risk
Aortic thrombosis	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Arterial disorder	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Arterial occlusive disease	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Arteriosclerosis	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Capillary fragility	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Circulatory collapse	Vascular disorders	MedDRA	Systematic Assessment	EG0003 affected2,049 at risk EG0014 affected2,062 at risk
Deep vein thrombosis	Vascular disorders	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0018 affected2,062 at risk
Embolism	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Extremity necrosis	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Femoral artery occlusion	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Haematoma	Vascular disorders	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0012 affected2,062 at risk
Haemorrhage	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Hypertension	Vascular disorders	MedDRA	Systematic Assessment	EG0007 affected2,049 at risk EG0014 affected2,062 at risk
Hypertensive crisis	Vascular disorders	MedDRA	Systematic Assessment	EG0004 affected2,049 at risk EG0010 affected2,062 at risk
Hypotension	Vascular disorders	MedDRA	Systematic Assessment	EG0003 affected2,049 at risk EG0011 affected2,062 at risk
Hypovolaemic shock	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Iliac artery occlusion	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0011 affected2,062 at risk
Intra-abdominal haematoma	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Lymphocele	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Lymphoedema	Vascular disorders	MedDRA	Systematic Assessment	EG0002 affected2,049 at risk EG0013 affected2,062 at risk
Orthostatic hypotension	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0012 affected2,062 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Peripheral artery stenosis	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Peripheral ischaemia	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0011 affected2,062 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Peripheral venous disease	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Temporal arteritis	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0011 affected2,062 at risk
Thromboangiitis obliterans	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Thrombosis	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Varicose vein	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected2,049 at risk EG0012 affected2,062 at risk
Vena cava thrombosis	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk
Venous thrombosis limb	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected2,049 at risk EG0010 affected2,062 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nausea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG000127 affected2,049 at risk EG001148 affected2,062 at risk
Fatigue	General disorders	MedDRA	Systematic Assessment	EG000345 affected2,049 at risk EG001341 affected2,062 at risk
Oedema peripheral	General disorders	MedDRA	Systematic Assessment	EG000100 affected2,049 at risk EG001104 affected2,062 at risk
Radiation skin injury	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG000120 affected2,049 at risk EG00188 affected2,062 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG000155 affected2,049 at risk EG001151 affected2,062 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG000983 affected2,049 at risk EG001983 affected2,062 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG000207 affected2,049 at risk EG001187 affected2,062 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG000138 affected2,049 at risk EG001120 affected2,062 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG000122 affected2,049 at risk EG001144 affected2,062 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG000232 affected2,049 at risk EG001211 affected2,062 at risk
Osteopenia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG000202 affected2,049 at risk EG001172 affected2,062 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG000221 affected2,049 at risk EG001224 affected2,062 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG000167 affected2,049 at risk EG001174 affected2,062 at risk
Dizziness	Nervous system disorders	MedDRA	Systematic Assessment	EG00092 affected2,049 at risk EG001107 affected2,062 at risk
Headache	Nervous system disorders	MedDRA	Systematic Assessment	EG000127 affected2,049 at risk EG001164 affected2,062 at risk
Depression	Psychiatric disorders	MedDRA	Systematic Assessment	EG000141 affected2,049 at risk EG001129 affected2,062 at risk
Insomnia	Psychiatric disorders	MedDRA	Systematic Assessment	EG000160 affected2,049 at risk EG001149 affected2,062 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG000106 affected2,049 at risk EG001120 affected2,062 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG000111 affected2,049 at risk EG00192 affected2,062 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG000126 affected2,049 at risk EG001134 affected2,062 at risk
Hot flush	Vascular disorders	MedDRA	Systematic Assessment	EG000666 affected2,049 at risk EG001666 affected2,062 at risk
Hypertension	Vascular disorders	MedDRA	Systematic Assessment	EG000152 affected2,049 at risk EG001145 affected2,062 at risk
Lymphoedema	Vascular disorders	MedDRA	Systematic Assessment	EG000158 affected2,049 at risk EG001177 affected2,062 at risk

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Term
D009570	Nitriles
D009930	Organic Chemicals
D014230	Triazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

ID	Title	Description
BG000	Letrozole	2.5 mg by mouth (p.o.) once daily
BG001	Anastrozole	1 mg p.o. once daily
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Letrozole	Letrozole			486	2,049	1,747	2,049
EG001	Anastrozole	Anastrozole			520	2,062	1,762	2,062