JUPITER - Crestor 20mg Versus Placebo in Prevention of Ca... | NCT00239681

NCT00239681

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
Rosuvastatin	Experimental	Rosuvastatin 20 mg once daily	Drug: Rosuvastatin
Placebo	Placebo Comparator	Placebo once daily	Other: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Rosuvastatin	Drug	Oral	Rosuvastatin	Crestor

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to Major Cardiac Event (Cardiovascular Death, Stroke, Myocardial Infarction, Hospitalization Due to Unstable Angina or Arterial Revascularization)	Days from randomization to the first of CV death, stroke, MI, hospitalization for unstable angina or arterial revascularization. If no event, censoring occurs at earliest of termination date or efficacy cut-off date of 30 Mar 2008. Events were adjudicated by an endpoint committee. Kaplan-Meier estimate of the mean	up to 5 years

Secondary Outcomes

Measure	Description	Time Frame
Time to Death Due to Any Cause	Days from randomization to death. If no death then censoring occurs at earliest of termination date or efficacy cutoff date of 30 Mar 2008. Kaplan-Meier estimate of the mean	up to 5 years
Time to Non-cardiovascular Death

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Judith Hsia, MD	AstraZeneca	Study Director
Paul Ridker, MD	Brigham and Women's Hospital	Study Chair

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

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38841856	Derived	Hoshi RA, Alotaibi M, Liu Y, Watrous JD, Ridker PM, Glynn RJ, Serhan CN, Luttmann-Gibson H, Moorthy MV, Jain M, Demler OV, Mora S. One-Year Effects of High-Intensity Statin on Bioactive Lipids: Findings From the JUPITER Trial. Arterioscler Thromb Vasc Biol. 2024 Jul;44(7):e196-e206. doi: 10.1161/ATVBAHA.124.321058. Epub 2024 Jun 6.
38018702

Label	URL
Related Info	View source

Results Section

Participant Flow Module

ID	Title	Description
FG000	Rosuvastatin	Rosuvastatin 20 mg once daily
FG001	Placebo	Placebo once daily

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG0001646.4± 2.76 OG0011578.3± 3.49

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Regression, Cox		<0.0001		Hazard Ratio (HR)	0.56				95	0.46	0.69			The hazard ratio shows (Rosuvastatin hazard/Placebo hazard)	No	Superiority or Other

Secondary

Time to Death Due to Any Cause

Days from randomization to death. If no death then censoring occurs at earliest of termination date or efficacy cutoff date of 30 Mar 2008. Kaplan-Meier estimate of the mean

Intention to treat population

Posted

Mean

Standard Error

days

up to 5 years

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin 20 mg once daily
OG001	Placebo	Placebo once daily

Units	Counts
Participants	OG000

Secondary

Time to Non-cardiovascular Death

Days from randomization to death from a non-cardiovascular cause. If no event, then censoring occurs at earliest of termination date or efficacy cutoff date of 30 Mar 2008. Events were adjudicated by an endpoint committee. Kaplan-Meier estimate of the mean

Intention to treat population

Posted

Mean

Standard Error

Days

up to 5 years

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin 20 mg once daily
OG001	Placebo	Placebo once daily

Units	Counts
Participants	OG000

Secondary

Time to Development of Diabetes Mellitus

Days from randomization until development of diabetes. If no diabetes was developed censoring occurred at termination date. Kaplan-Meier estimate of the mean

Intention to treat population

Posted

Mean

Standard Error

Days

up to 5 years

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin 20 mg once daily
OG001	Placebo	Placebo once daily

Units	Counts
Participants	OG000

Secondary

Time to Venous Thromboembolic Event

Time from randomization to the first venous thromboembolic event. Kaplan-Meier estimate of the mean

Intention to treat population

Posted

Mean

Standard Error

Days

up to 5 years

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin 20 mg once daily
OG001	Placebo	Placebo once daily

Units	Counts
Participants	OG000

Secondary

Time to Bone Fracture

Days from randomization until bone fracture. If no event, then censoring occurs at earliest of termination date or efficacy cutoff date of 30 Mar 2008. Kaplan-Meier estimate of the mean

Intention to treat population

Posted

Mean

Standard Error

Days

Up to 5 years

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin 20 mg once daily
OG001	Placebo	Placebo once daily

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	PLACEBO				1,216	8,864	3,170	8,864
EG001	ROSUVASTATIN 20 MG				1,205	8,869	3,228	8,869

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG00011 events11 affected8,864 at risk EG00115 events15 affected8,869 at risk
Anaemia megaloblastic	Blood and lymphatic system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Anaemia of chronic disease	Blood and lymphatic system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Aplastic anaemia	Blood and lymphatic system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Bone marrow failure	Blood and lymphatic system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Haemolytic anaemia	Blood and lymphatic system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0011 events1 affected8,869 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0012 events2 affected8,869 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0014 events4 affected8,869 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Lymphadenopathy mediastinal	Blood and lymphatic system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Normochromic normocytic anaemia	Blood and lymphatic system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0011 events1 affected8,869 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Pernicious anaemia	Blood and lymphatic system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Splenic haemorrhage	Blood and lymphatic system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Splenic infarction	Blood and lymphatic system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Splenomegaly	Blood and lymphatic system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0011 events1 affected8,869 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0011 events1 affected8,869 at risk
Thrombocytopenic purpura	Blood and lymphatic system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
AV dissociation	Cardiac disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0003 events3 affected8,864 at risk EG0010 events0 affected8,869 at risk
Angina pectoris	Cardiac disorders	MedDRA MedDRA14.0	Systematic Assessment	EG00010 events10 affected8,864 at risk EG00110 events10 affected8,869 at risk
Angina unstable	Cardiac disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0006 events6 affected8,864 at risk EG0013 events3 affected8,869 at risk
Aortic valve incompetence	Cardiac disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0012 events2 affected8,869 at risk
Arrhythmia	Cardiac disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0014 events4 affected8,869 at risk
Atrial fibrillation	Cardiac disorders	MedDRA MedDRA14.0	Systematic Assessment	EG00065 events65 affected8,864 at risk EG00156 events56 affected8,869 at risk
Atrial flutter	Cardiac disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0009 events9 affected8,864 at risk EG0015 events5 affected8,869 at risk
Atrial tachycardia	Cardiac disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0003 events3 affected8,864 at risk EG0010 events0 affected8,869 at risk
Atrioventricular block	Cardiac disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0015 events5 affected8,869 at risk
Atrioventricular block first degree	Cardiac disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Atrioventricular block second degree	Cardiac disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Bradyarrhythmia	Cardiac disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Bradycardia	Cardiac disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0006 events6 affected8,864 at risk EG00110 events10 affected8,869 at risk
Bundle branch block left	Cardiac disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Cardiac arrest	Cardiac disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Cardiac asthma	Cardiac disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Cardiac failure	Cardiac disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0005 events5 affected8,864 at risk EG0016 events6 affected8,869 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA MedDRA14.0	Systematic Assessment	EG00019 events19 affected8,864 at risk EG00116 events16 affected8,869 at risk
Cardiac valve sclerosis	Cardiac disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Cardiomyopathy	Cardiac disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0003 events3 affected8,864 at risk EG0012 events2 affected8,869 at risk
Congestive cardiomyopathy	Cardiac disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0010 events0 affected8,869 at risk
Coronary artery disease	Cardiac disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0003 events3 affected8,864 at risk EG0013 events3 affected8,869 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Extrasystoles	Cardiac disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0011 events1 affected8,869 at risk
Intracardiac thrombus	Cardiac disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Left ventricular failure	Cardiac disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0011 events1 affected8,869 at risk
Mitral valve disease	Cardiac disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0003 events3 affected8,864 at risk EG0013 events3 affected8,869 at risk
Myocardial infarction	Cardiac disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0007 events7 affected8,864 at risk EG0013 events3 affected8,869 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0003 events3 affected8,864 at risk EG0012 events2 affected8,869 at risk
Myocarditis	Cardiac disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Palpitations	Cardiac disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0003 events3 affected8,864 at risk EG0013 events3 affected8,869 at risk
Pericardial effusion	Cardiac disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0011 events1 affected8,869 at risk
Pericarditis	Cardiac disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0012 events2 affected8,869 at risk
Sick sinus syndrome	Cardiac disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0006 events6 affected8,864 at risk EG0015 events5 affected8,869 at risk
Sinus bradycardia	Cardiac disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0010 events0 affected8,869 at risk
Sinus tachycardia	Cardiac disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0013 events3 affected8,869 at risk
Supraventricular extrasystoles	Cardiac disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0003 events3 affected8,864 at risk EG0013 events3 affected8,869 at risk
Tachycardia	Cardiac disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0011 events1 affected8,869 at risk
Tachycardia paroxysmal	Cardiac disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Tricuspid valve incompetence	Cardiac disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Ventricular arrhythmia	Cardiac disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0011 events1 affected8,869 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0012 events2 affected8,869 at risk
Ventricular flutter	Cardiac disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0011 events1 affected8,869 at risk
Wolff-Parkinson-White syndrome	Cardiac disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Congenital intestinal malformation	Congenital, familial and genetic disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Duchenne muscular dystrophy	Congenital, familial and genetic disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Hereditary haemorrhagic telangiectasia	Congenital, familial and genetic disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Hydrocele	Congenital, familial and genetic disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0012 events2 affected8,869 at risk
Lymphangioma	Congenital, familial and genetic disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Phimosis	Congenital, familial and genetic disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Auricular swelling	Ear and labyrinth disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Deafness unilateral	Ear and labyrinth disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0010 events0 affected8,869 at risk
Meniere's disease	Ear and labyrinth disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Tympanic membrane perforation	Ear and labyrinth disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Vertigo	Ear and labyrinth disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0003 events3 affected8,864 at risk EG0014 events4 affected8,869 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0012 events2 affected8,869 at risk
Vestibular neuronitis	Ear and labyrinth disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Addison's disease	Endocrine disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Hyperparathyroidism	Endocrine disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0011 events1 affected8,869 at risk
Hyperthyroidism	Endocrine disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0014 events4 affected8,869 at risk
Inappropriate antidiuretic hormone secretion	Endocrine disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Pituitary cyst	Endocrine disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Thyroid disorder	Endocrine disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0012 events2 affected8,869 at risk
Thyroid mass	Endocrine disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0010 events0 affected8,869 at risk
Amaurosis fugax	Eye disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Blindness	Eye disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Cataract	Eye disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0008 events8 affected8,864 at risk EG0013 events3 affected8,869 at risk
Diplopia	Eye disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Ectropion	Eye disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Endophthalmitis	Eye disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0012 events2 affected8,869 at risk
Eye haemorrhage	Eye disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Eyelid ptosis	Eye disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Lacrimal disorder	Eye disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Lenticular opacities	Eye disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Macular degeneration	Eye disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Retinal detachment	Eye disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0003 events3 affected8,864 at risk EG0013 events3 affected8,869 at risk
Retinal tear	Eye disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0010 events0 affected8,869 at risk
Visual acuity reduced	Eye disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Visual disturbance	Eye disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Vitreous detachment	Eye disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0013 events3 affected8,869 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0007 events7 affected8,864 at risk EG0019 events9 affected8,869 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0005 events5 affected8,864 at risk EG0014 events4 affected8,869 at risk
Abdominal strangulated hernia	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Abdominal wall disorder	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Abdominal wall haematoma	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Anal fistula	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0010 events0 affected8,869 at risk
Appendicitis perforated	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Barrett's oesophagus	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Colitis	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0004 events4 affected8,864 at risk EG0010 events0 affected8,869 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0012 events2 affected8,869 at risk
Colitis ulcerative	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0012 events2 affected8,869 at risk
Colonic polyp	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0003 events3 affected8,864 at risk EG0014 events4 affected8,869 at risk
Colonic stenosis	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0011 events1 affected8,869 at risk
Constipation	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Crohn's disease	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0013 events3 affected8,869 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0008 events8 affected8,864 at risk EG0015 events5 affected8,869 at risk
Diverticulum	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0014 events4 affected8,869 at risk
Diverticulum intestinal	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0012 events2 affected8,869 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0011 events1 affected8,869 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Duodenal ulcer perforation	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Duodenitis	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Dysphagia	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Enterocele	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Enterovesical fistula	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0012 events2 affected8,869 at risk
Erosive oesophagitis	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0012 events2 affected8,869 at risk
Faecaloma	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Food poisoning	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Gastric perforation	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Gastric polyps	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0006 events6 affected8,864 at risk EG0012 events2 affected8,869 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0013 events3 affected8,869 at risk
Gastric ulcer perforation	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Gastritis	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0004 events4 affected8,864 at risk EG0013 events3 affected8,869 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Gastritis haemorrhagic	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0010 events0 affected8,869 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG00013 events13 affected8,864 at risk EG00120 events20 affected8,869 at risk
Gastrointestinal inflammation	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Gastrointestinal pain	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0004 events4 affected8,864 at risk EG0012 events2 affected8,869 at risk
Haematemesis	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0011 events1 affected8,869 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0013 events3 affected8,869 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0014 events4 affected8,869 at risk
Ileus	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0011 events1 affected8,869 at risk
Ileus paralytic	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0012 events2 affected8,869 at risk
Impaired gastric emptying	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG00015 events15 affected8,864 at risk EG00117 events17 affected8,869 at risk
Inguinal hernia, obstructive	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0007 events7 affected8,864 at risk EG00111 events11 affected8,869 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0010 events0 affected8,869 at risk
Intestinal stenosis	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Intra-abdominal haematoma	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Intra-abdominal haemorrhage	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0012 events2 affected8,869 at risk
Irritable bowel syndrome	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0012 events2 affected8,869 at risk
Large intestinal haemorrhage	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Nausea	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0011 events1 affected8,869 at risk
Odynophagia	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Oesophageal achalasia	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Oesophageal haemorrhage	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Oesophageal rupture	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Oesophageal varices haemorrhage	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Oesophagitis haemorrhagic	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0006 events6 affected8,864 at risk EG0013 events3 affected8,869 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0006 events6 affected8,864 at risk EG0019 events9 affected8,869 at risk
Pancreatolithiasis	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Peptic ulcer	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0012 events2 affected8,869 at risk
Peptic ulcer haemorrhage	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0011 events1 affected8,869 at risk
Peritonitis	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0003 events3 affected8,864 at risk EG0014 events4 affected8,869 at risk
Proctalgia	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0004 events4 affected8,864 at risk EG0011 events1 affected8,869 at risk
Rectal polyp	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0012 events2 affected8,869 at risk
Rectal prolapse	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0012 events2 affected8,869 at risk
Retroperitoneal haematoma	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Salivary gland calculus	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Salivary gland cyst	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0012 events2 affected8,869 at risk
Small intestinal haemorrhage	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0011 events1 affected8,869 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0007 events7 affected8,864 at risk EG0015 events5 affected8,869 at risk
Spigelian hernia	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Swollen tongue	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0005 events5 affected8,864 at risk EG0018 events8 affected8,869 at risk
Umbilical hernia, obstructive	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Volvulus	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Vomiting	Gastrointestinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0012 events2 affected8,869 at risk
Adhesion	General disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Adverse drug reaction	General disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Asthenia	General disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0010 events0 affected8,869 at risk
Calcinosis	General disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Chest discomfort	General disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0012 events2 affected8,869 at risk
Chest pain	General disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0007 events7 affected8,864 at risk EG0019 events9 affected8,869 at risk
Death	General disorders	MedDRA MedDRA14.0	Systematic Assessment	EG00034 events34 affected8,864 at risk EG00130 events30 affected8,869 at risk
Deformity	General disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Dysplasia	General disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Fatigue	General disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
General physical health deterioration	General disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Hernia	General disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0012 events2 affected8,869 at risk
Hernia obstructive	General disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Malaise	General disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Mucosal inflammation	General disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Multi-organ failure	General disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0012 events2 affected8,869 at risk
Non-cardiac chest pain	General disorders	MedDRA MedDRA14.0	Systematic Assessment	EG00022 events22 affected8,864 at risk EG00129 events29 affected8,869 at risk
Oedema peripheral	General disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0005 events5 affected8,864 at risk EG0011 events1 affected8,869 at risk
Pyrexia	General disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0014 events4 affected8,869 at risk
Sudden death	General disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Ulcer	General disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Ulcer haemorrhage	General disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0005 events5 affected8,864 at risk EG0014 events4 affected8,869 at risk
Biliary colic	Hepatobiliary disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0012 events2 affected8,869 at risk
Biliary dyskinesia	Hepatobiliary disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0011 events1 affected8,869 at risk
Cholangitis	Hepatobiliary disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Cholangitis sclerosing	Hepatobiliary disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0009 events9 affected8,864 at risk EG00110 events10 affected8,869 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0005 events5 affected8,864 at risk EG0014 events4 affected8,869 at risk
Cholecystitis chronic	Hepatobiliary disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0004 events4 affected8,864 at risk EG0010 events0 affected8,869 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA MedDRA14.0	Systematic Assessment	EG00023 events23 affected8,864 at risk EG00122 events22 affected8,869 at risk
Cirrhosis alcoholic	Hepatobiliary disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Gallbladder polyp	Hepatobiliary disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Hepatic cyst	Hepatobiliary disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0011 events1 affected8,869 at risk
Hepatic cyst ruptured	Hepatobiliary disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0010 events0 affected8,869 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Hepatic mass	Hepatobiliary disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Hepatic pain	Hepatobiliary disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Hepatitis	Hepatobiliary disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0012 events2 affected8,869 at risk
Hepatitis cholestatic	Hepatobiliary disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Hydrocholecystis	Hepatobiliary disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Jaundice	Hepatobiliary disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0011 events1 affected8,869 at risk
Jaundice cholestatic	Hepatobiliary disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0010 events0 affected8,869 at risk
Allergy to arthropod sting	Immune system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Anaphylactic reaction	Immune system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0012 events2 affected8,869 at risk
Drug hypersensitivity	Immune system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0014 events4 affected8,869 at risk
Sarcoidosis	Immune system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0011 events1 affected8,869 at risk
Abdominal sepsis	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Abdominal wall abscess	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Abscess	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Abscess intestinal	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Abscess limb	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0011 events1 affected8,869 at risk
Abscess rupture	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Appendicitis	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0007 events7 affected8,864 at risk EG0015 events5 affected8,869 at risk
Arthritis bacterial	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Arthritis infective	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0003 events3 affected8,864 at risk EG0011 events1 affected8,869 at risk
Aspergillosis	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Atypical mycobacterial infection	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Bacteraemia	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0003 events3 affected8,864 at risk EG0011 events1 affected8,869 at risk
Bacterial infection	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0011 events1 affected8,869 at risk
Bronchiectasis	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0012 events2 affected8,869 at risk
Bronchitis	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0005 events5 affected8,864 at risk EG0017 events7 affected8,869 at risk
Bronchitis bacterial	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Bronchopneumonia	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0003 events3 affected8,864 at risk EG0012 events2 affected8,869 at risk
Campylobacter gastroenteritis	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Cellulitis	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG00020 events20 affected8,864 at risk EG00113 events13 affected8,869 at risk
Cholecystitis infective	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0011 events1 affected8,869 at risk
Chronic sinusitis	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Clostridial infection	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0011 events1 affected8,869 at risk
Corneal abscess	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Cystitis	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Device related infection	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Diarrhoea infectious	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Diverticulitis	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG00016 events16 affected8,864 at risk EG00113 events13 affected8,869 at risk
Empyema	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0011 events1 affected8,869 at risk
Endocarditis	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Enterocolitis infectious	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0012 events2 affected8,869 at risk
Epiglottitis	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Erysipelas	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0011 events1 affected8,869 at risk
Gangrene	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Gastroenteritis	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG00011 events11 affected8,864 at risk EG0018 events8 affected8,869 at risk
Gastroenteritis clostridial	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Gastroenteritis viral	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0011 events1 affected8,869 at risk
HIV infection	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0011 events1 affected8,869 at risk
Haematoma infection	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Hepatitis A	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0011 events1 affected8,869 at risk
Hepatitis C	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Herpes zoster	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Incision site cellulitis	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Infected cyst	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Infected skin ulcer	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Infection	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0010 events0 affected8,869 at risk
Infectious mononucleosis	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Influenza	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0013 events3 affected8,869 at risk
Labyrinthitis	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Laryngitis	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Liver abscess	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0011 events1 affected8,869 at risk
Localised infection	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0011 events1 affected8,869 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0009 events9 affected8,864 at risk EG0014 events4 affected8,869 at risk
Lung abscess	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0010 events0 affected8,869 at risk
Lung infection	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0010 events0 affected8,869 at risk
Lymphangitis	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Meningitis pneumococcal	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Meningococcal sepsis	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Nasopharyngitis	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0013 events3 affected8,869 at risk
Oral herpes	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Orchitis	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Osteomyelitis	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0003 events3 affected8,864 at risk EG0010 events0 affected8,869 at risk
Otitis media	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Parotid abscess	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Pelvic abscess	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Perianal abscess	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Pneumococcal sepsis	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0012 events2 affected8,869 at risk
Pneumonia	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG00057 events57 affected8,864 at risk EG00156 events56 affected8,869 at risk
Pneumonia bacterial	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0012 events2 affected8,869 at risk
Pneumonia chlamydial	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Pneumonia viral	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Postoperative wound infection	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0012 events2 affected8,869 at risk
Prostate infection	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Pseudomonas infection	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Pulmonary tuberculosis	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0003 events3 affected8,864 at risk EG0012 events2 affected8,869 at risk
Pyelonephritis	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0012 events2 affected8,869 at risk
Pyelonephritis acute	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Rash pustular	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Rectal abscess	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Respiratory tract infection	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Scrotal infection	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Sepsis	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0005 events5 affected8,864 at risk EG00111 events11 affected8,869 at risk
Septic shock	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0014 events4 affected8,869 at risk
Sialoadenitis	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Sinusitis	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0011 events1 affected8,869 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Staphylococcal infection	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0011 events1 affected8,869 at risk
Subacute endocarditis	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Subcutaneous abscess	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0013 events3 affected8,869 at risk
Tooth abscess	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Tracheitis	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Urinary tract infection	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0006 events6 affected8,864 at risk EG00115 events15 affected8,869 at risk
Urosepsis	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0004 events4 affected8,864 at risk EG0010 events0 affected8,869 at risk
Viral infection	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0012 events2 affected8,869 at risk
Viral pericarditis	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0010 events0 affected8,869 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Vulvitis	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Wound infection	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0004 events4 affected8,864 at risk EG0011 events1 affected8,869 at risk
Wound sepsis	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Alcohol poisoning	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Anaemia postoperative	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0012 events2 affected8,869 at risk
Animal bite	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0009 events9 affected8,864 at risk EG00114 events14 affected8,869 at risk
Back injury	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0011 events1 affected8,869 at risk
Bone fissure	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Brain contusion	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0011 events1 affected8,869 at risk
Cartilage injury	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Caustic injury	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0003 events3 affected8,864 at risk EG0010 events0 affected8,869 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0003 events3 affected8,864 at risk EG0011 events1 affected8,869 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0003 events3 affected8,864 at risk EG0010 events0 affected8,869 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0013 events3 affected8,869 at risk
Crush injury	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Device dislocation	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Dislocation of joint prosthesis	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0012 events2 affected8,869 at risk
Drug toxicity	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0013 events3 affected8,869 at risk
Eye injury	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0012 events2 affected8,869 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Fall	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0003 events3 affected8,864 at risk EG0013 events3 affected8,869 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0013 events3 affected8,869 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0006 events6 affected8,864 at risk EG0018 events8 affected8,869 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0012 events2 affected8,869 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0003 events3 affected8,864 at risk EG0012 events2 affected8,869 at risk
Forearm fracture	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0003 events3 affected8,864 at risk EG0013 events3 affected8,869 at risk
Foreign body in eye	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Fracture	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0010 events0 affected8,869 at risk
Gun shot wound	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0004 events4 affected8,864 at risk EG0012 events2 affected8,869 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0005 events5 affected8,864 at risk EG0012 events2 affected8,869 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG00014 events14 affected8,864 at risk EG00115 events15 affected8,869 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0003 events3 affected8,864 at risk EG0011 events1 affected8,869 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0003 events3 affected8,864 at risk EG0010 events0 affected8,869 at risk
Injury	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0011 events1 affected8,869 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0005 events5 affected8,864 at risk EG0015 events5 affected8,869 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0003 events3 affected8,864 at risk EG0014 events4 affected8,869 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0003 events3 affected8,864 at risk EG0010 events0 affected8,869 at risk
Ligament injury	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Ligament rupture	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0012 events2 affected8,869 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0012 events2 affected8,869 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0004 events4 affected8,864 at risk EG0015 events5 affected8,869 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0012 events2 affected8,869 at risk
Lung injury	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Medical device complication	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0014 events4 affected8,869 at risk
Meniscus lesion	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0012 events2 affected8,869 at risk
Multiple fractures	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0012 events2 affected8,869 at risk
Multiple injuries	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Muscle injury	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Neck injury	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Nerve injury	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Patella fracture	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Periorbital haematoma	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0011 events1 affected8,869 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0003 events3 affected8,864 at risk EG0011 events1 affected8,869 at risk
Post-traumatic pain	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Postoperative ileus	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0012 events2 affected8,869 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Pubic rami fracture	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0014 events4 affected8,869 at risk
Retinal injury	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0008 events8 affected8,864 at risk EG0014 events4 affected8,869 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0004 events4 affected8,864 at risk EG0013 events3 affected8,869 at risk
Scrotal haematoma	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0013 events3 affected8,869 at risk
Skull fracture	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0011 events1 affected8,869 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0011 events1 affected8,869 at risk
Splenic rupture	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Sternal fracture	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0013 events3 affected8,869 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0014 events4 affected8,869 at risk
Synovial rupture	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Tendon injury	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0011 events1 affected8,869 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0003 events3 affected8,864 at risk EG0012 events2 affected8,869 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0013 events3 affected8,869 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0003 events3 affected8,864 at risk EG0012 events2 affected8,869 at risk
Traumatic brain injury	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0011 events1 affected8,869 at risk
Ulna fracture	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0011 events1 affected8,869 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0005 events5 affected8,864 at risk EG0013 events3 affected8,869 at risk
Urinary retention postoperative	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0012 events2 affected8,869 at risk
Wound	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0012 events2 affected8,869 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA MedDRA14.0	Systematic Assessment	EG0003 events3 affected8,864 at risk EG0014 events4 affected8,869 at risk
Alanine aminotransferase increased	Investigations	MedDRA MedDRA14.0	Systematic Assessment	EG0003 events3 affected8,864 at risk EG0010 events0 affected8,869 at risk
Anticonvulsant drug level increased	Investigations	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Blood creatinine increased	Investigations	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Blood pressure increased	Investigations	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0011 events1 affected8,869 at risk
Electrocardiogram T wave inversion	Investigations	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Heart rate increased	Investigations	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Heart rate irregular	Investigations	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
International normalised ratio increased	Investigations	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Oxygen saturation decreased	Investigations	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Prostatic specific antigen increased	Investigations	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Weight decreased	Investigations	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
White blood cell count increased	Investigations	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0008 events8 affected8,864 at risk EG0015 events5 affected8,869 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA MedDRA14.0	Systematic Assessment	EG00013 events13 affected8,864 at risk EG00114 events14 affected8,869 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0012 events2 affected8,869 at risk
Gout	Metabolism and nutrition disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0011 events1 affected8,869 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0011 events1 affected8,869 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Hypermagnesaemia	Metabolism and nutrition disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Hypernatraemia	Metabolism and nutrition disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Hyperphosphataemia	Metabolism and nutrition disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0013 events3 affected8,869 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0015 events5 affected8,869 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0004 events4 affected8,864 at risk EG0013 events3 affected8,869 at risk
Lipomatosis	Metabolism and nutrition disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0012 events2 affected8,869 at risk
Obesity	Metabolism and nutrition disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Ankylosing spondylitis	Musculoskeletal and connective tissue disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0017 events7 affected8,869 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA MedDRA14.0	Systematic Assessment	EG00053 events53 affected8,864 at risk EG00148 events48 affected8,869 at risk
Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0013 events3 affected8,869 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0006 events6 affected8,864 at risk EG0018 events8 affected8,869 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0003 events3 affected8,864 at risk EG0016 events6 affected8,869 at risk
Bunion	Musculoskeletal and connective tissue disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0011 events1 affected8,869 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0013 events3 affected8,869 at risk
Intervertebral disc disorder	Musculoskeletal and connective tissue disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0011 events1 affected8,869 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA MedDRA14.0	Systematic Assessment	EG00012 events12 affected8,864 at risk EG0019 events9 affected8,869 at risk
Joint contracture	Musculoskeletal and connective tissue disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Joint crepitation	Musculoskeletal and connective tissue disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Joint effusion	Musculoskeletal and connective tissue disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0004 events4 affected8,864 at risk EG0016 events6 affected8,869 at risk
Muscle atrophy	Musculoskeletal and connective tissue disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Muscle disorder	Musculoskeletal and connective tissue disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Muscle haemorrhage	Musculoskeletal and connective tissue disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0011 events1 affected8,869 at risk
Muscle swelling	Musculoskeletal and connective tissue disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0003 events3 affected8,864 at risk EG0016 events6 affected8,869 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0015 events5 affected8,869 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA MedDRA14.0	Systematic Assessment	EG00015 events15 affected8,864 at risk EG00117 events17 affected8,869 at risk
Osteolysis	Musculoskeletal and connective tissue disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0013 events3 affected8,869 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0011 events1 affected8,869 at risk
Polymyalgia rheumatica	Musculoskeletal and connective tissue disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Polymyositis	Musculoskeletal and connective tissue disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Pseudarthrosis	Musculoskeletal and connective tissue disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0006 events6 affected8,864 at risk EG0016 events6 affected8,869 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0004 events4 affected8,864 at risk EG0012 events2 affected8,869 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0014 events4 affected8,869 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0011 events1 affected8,869 at risk
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Acute myelomonocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Adenoma benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Adrenal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Anal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Astrocytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Astrocytoma malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0005 events5 affected8,864 at risk EG00111 events11 affected8,869 at risk
Benign breast neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Benign neoplasm of bladder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Benign neoplasm of thyroid gland	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Benign renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Benign salivary gland neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Bile duct cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Bile duct cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0008 events8 affected8,864 at risk EG0015 events5 affected8,869 at risk
Bladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0007 events7 affected8,864 at risk EG0012 events2 affected8,869 at risk
Bladder papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0011 events1 affected8,869 at risk
Bowen's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0011 events1 affected8,869 at risk
Brain cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Brain neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0012 events2 affected8,869 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG00022 events22 affected8,864 at risk EG00120 events20 affected8,869 at risk
Breast cancer in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0012 events2 affected8,869 at risk
Breast cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0015 events5 affected8,869 at risk
Bronchial neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Carcinoid tumour of the small bowel	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Carcinoid tumour of the stomach	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Carcinoma in situ of bladder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Cervix carcinoma stage III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Cervix neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Cholesteatoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Chronic lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0012 events2 affected8,869 at risk
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0012 events2 affected8,869 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG00020 events20 affected8,864 at risk EG00116 events16 affected8,869 at risk
Colon cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0011 events1 affected8,869 at risk
Colon cancer stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Colon cancer stage III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Colon neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0013 events3 affected8,869 at risk
Endometrial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0015 events5 affected8,869 at risk
Ganglioneuroma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0004 events4 affected8,864 at risk EG0014 events4 affected8,869 at risk
Gastrointestinal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0011 events1 affected8,869 at risk
Gastrointestinal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0005 events5 affected8,864 at risk EG0014 events4 affected8,869 at risk
Gastrointestinal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0010 events0 affected8,869 at risk
Gastrointestinal stromal tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Gastrooesophageal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0011 events1 affected8,869 at risk
Glioblastoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Glioblastoma multiforme	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Glioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Head and neck cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Hepatic cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0011 events1 affected8,869 at risk
Hepatic neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0011 events1 affected8,869 at risk
Hodgkin's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Hypopharyngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Large cell carcinoma of the respiratory tract stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Laryngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Leiomyosarcoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0011 events1 affected8,869 at risk
Lip and/or oral cavity cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0011 events1 affected8,869 at risk
Liposarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0014 events4 affected8,869 at risk
Lung adenocarcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0003 events3 affected8,864 at risk EG0013 events3 affected8,869 at risk
Lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0007 events7 affected8,864 at risk EG0012 events2 affected8,869 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG00013 events13 affected8,864 at risk EG00110 events10 affected8,869 at risk
Lung squamous cell carcinoma stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0012 events2 affected8,869 at risk
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0003 events3 affected8,864 at risk EG0014 events4 affected8,869 at risk
Lymphoplasmacytoid lymphoma/immunocytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0004 events4 affected8,864 at risk EG0014 events4 affected8,869 at risk
Mantle cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Melanocytic naevus	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0012 events2 affected8,869 at risk
Mesothelioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0012 events2 affected8,869 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0012 events2 affected8,869 at risk
Metastases to lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Metastatic malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0012 events2 affected8,869 at risk
Metastatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0012 events2 affected8,869 at risk
Metastatic squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Multiple myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0013 events3 affected8,869 at risk
Mycosis fungoides	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0012 events2 affected8,869 at risk
Myelofibrosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Nasopharyngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0011 events1 affected8,869 at risk
Neoplasm prostate	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Neuroendocrine carcinoma of the skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Neurofibroma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Non-Hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0017 events7 affected8,869 at risk
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0016 events6 affected8,869 at risk
Non-small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Ocular neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Oesophageal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0012 events2 affected8,869 at risk
Oesophageal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Oesophageal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0006 events6 affected8,864 at risk EG0013 events3 affected8,869 at risk
Oesophageal squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Ovarian adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Ovarian cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0004 events4 affected8,864 at risk EG0012 events2 affected8,869 at risk
Ovarian cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Ovarian fibroma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Ovarian neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0011 events1 affected8,869 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0006 events6 affected8,864 at risk EG0014 events4 affected8,869 at risk
Pancreatic carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0010 events0 affected8,869 at risk
Pancreatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Papillary thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0010 events0 affected8,869 at risk
Papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Parathyroid tumour benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Penis carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Phaeochromocytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Pharyngeal cancer stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Pituitary tumour benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0012 events2 affected8,869 at risk
Plasmacytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Polycythaemia vera	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG00038 events38 affected8,864 at risk EG00134 events34 affected8,869 at risk
Prostate cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Prostatic adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Pseudomyxoma peritonei	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0006 events6 affected8,864 at risk EG0011 events1 affected8,869 at risk
Rectal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Rectosigmoid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0012 events2 affected8,869 at risk
Renal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0012 events2 affected8,869 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0005 events5 affected8,864 at risk EG0015 events5 affected8,869 at risk
Renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Renal oncocytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Rhabdomyosarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Salivary gland cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Sarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0010 events0 affected8,869 at risk
Signet-ring cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Skin cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Skin neoplasm bleeding	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Small cell lung cancer stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0011 events1 affected8,869 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0012 events2 affected8,869 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0014 events4 affected8,869 at risk
Squamous cell carcinoma of the cervix	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
T-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Testis cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Throat cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Thyroid adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0011 events1 affected8,869 at risk
Thyroid neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0012 events2 affected8,869 at risk
Tongue neoplasm malignant stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0011 events1 affected8,869 at risk
Tonsil cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0010 events0 affected8,869 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0013 events3 affected8,869 at risk
Ureteric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0012 events2 affected8,869 at risk
Ureteric cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Uterine cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0014 events4 affected8,869 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Waldenstrom's macroglobulinaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0011 events1 affected8,869 at risk
Amyotrophic lateral sclerosis	Nervous system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0011 events1 affected8,869 at risk
Anoxic encephalopathy	Nervous system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Anticholinergic syndrome	Nervous system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Carotid sinus syndrome	Nervous system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0011 events1 affected8,869 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0011 events1 affected8,869 at risk
Cerebellar atrophy	Nervous system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0011 events1 affected8,869 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0005 events5 affected8,864 at risk EG0019 events9 affected8,869 at risk
Cerebrovascular disorder	Nervous system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Cervical myelopathy	Nervous system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Cervicobrachial syndrome	Nervous system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Cognitive disorder	Nervous system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Convulsion	Nervous system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0012 events2 affected8,869 at risk
Dementia Alzheimer's type	Nervous system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0010 events0 affected8,869 at risk
Demyelinating polyneuropathy	Nervous system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Dizziness	Nervous system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0007 events7 affected8,864 at risk EG0013 events3 affected8,869 at risk
Drop attacks	Nervous system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Drug withdrawal convulsions	Nervous system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Dysaesthesia	Nervous system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Encephalitis	Nervous system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Encephalopathy	Nervous system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Epilepsy	Nervous system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0013 events3 affected8,869 at risk
Facial neuralgia	Nervous system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Facial palsy	Nervous system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0012 events2 affected8,869 at risk
Grand mal convulsion	Nervous system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0012 events2 affected8,869 at risk
Headache	Nervous system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0003 events3 affected8,864 at risk EG0013 events3 affected8,869 at risk
Hemicephalalgia	Nervous system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Hemiparesis	Nervous system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Hydrocephalus	Nervous system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Hypertensive encephalopathy	Nervous system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Hypertonia	Nervous system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Hypoaesthesia	Nervous system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Hypoglycaemic coma	Nervous system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Intracranial aneurysm	Nervous system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Intracranial pressure increased	Nervous system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Ischaemic stroke	Nervous system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0011 events1 affected8,869 at risk
Lacunar infarction	Nervous system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0011 events1 affected8,869 at risk
Loss of consciousness	Nervous system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0012 events2 affected8,869 at risk
Lumbar radiculopathy	Nervous system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Migraine	Nervous system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Myasthenia gravis	Nervous system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Myxoedema coma	Nervous system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Nerve compression	Nervous system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0011 events1 affected8,869 at risk
Nerve root compression	Nervous system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Optic neuritis	Nervous system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Paralysis	Nervous system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Paraplegia	Nervous system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Peripheral paralysis	Nervous system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Pneumocephalus	Nervous system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Polyneuropathy	Nervous system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Presyncope	Nervous system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0015 events5 affected8,869 at risk
Radiculitis	Nervous system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Radiculopathy	Nervous system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0010 events0 affected8,869 at risk
Ruptured cerebral aneurysm	Nervous system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Sciatica	Nervous system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0003 events3 affected8,864 at risk EG0012 events2 affected8,869 at risk
Senile dementia	Nervous system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Sensory loss	Nervous system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Spinal cord compression	Nervous system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Syncope	Nervous system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG00015 events15 affected8,864 at risk EG00111 events11 affected8,869 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG00010 events10 affected8,864 at risk EG0019 events9 affected8,869 at risk
Tremor	Nervous system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Vertebral artery stenosis	Nervous system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Vocal cord paralysis	Nervous system disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0012 events2 affected8,869 at risk
Aggression	Psychiatric disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Alcohol abuse	Psychiatric disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Alcoholism	Psychiatric disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Anxiety	Psychiatric disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0012 events2 affected8,869 at risk
Completed suicide	Psychiatric disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0011 events1 affected8,869 at risk
Confusional state	Psychiatric disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0017 events7 affected8,869 at risk
Delirium	Psychiatric disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0012 events2 affected8,869 at risk
Depression	Psychiatric disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0017 events7 affected8,869 at risk
Insomnia	Psychiatric disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0012 events2 affected8,869 at risk
Major depression	Psychiatric disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0012 events2 affected8,869 at risk
Mental status changes	Psychiatric disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0012 events2 affected8,869 at risk
Panic attack	Psychiatric disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Psychotic disorder	Psychiatric disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Suicidal ideation	Psychiatric disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0012 events2 affected8,869 at risk
Suicide attempt	Psychiatric disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Azotaemia	Renal and urinary disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Bladder diverticulum	Renal and urinary disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Bladder obstruction	Renal and urinary disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Bladder prolapse	Renal and urinary disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0005 events5 affected8,864 at risk EG0010 events0 affected8,869 at risk
Bladder stenosis	Renal and urinary disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Calculus bladder	Renal and urinary disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0011 events1 affected8,869 at risk
Calculus urinary	Renal and urinary disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Cystitis interstitial	Renal and urinary disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Dysuria	Renal and urinary disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Glomerulonephritis	Renal and urinary disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Haematuria	Renal and urinary disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0006 events6 affected8,864 at risk EG00111 events11 affected8,869 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA MedDRA14.0	Systematic Assessment	EG00012 events12 affected8,864 at risk EG0017 events7 affected8,869 at risk
Pollakiuria	Renal and urinary disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Renal artery stenosis	Renal and urinary disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Renal colic	Renal and urinary disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0004 events4 affected8,864 at risk EG0011 events1 affected8,869 at risk
Renal cyst	Renal and urinary disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0011 events1 affected8,869 at risk
Renal failure	Renal and urinary disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0007 events7 affected8,864 at risk EG0016 events6 affected8,869 at risk
Renal failure acute	Renal and urinary disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0006 events6 affected8,864 at risk EG0016 events6 affected8,869 at risk
Renal failure chronic	Renal and urinary disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0011 events1 affected8,869 at risk
Renal haemorrhage	Renal and urinary disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Renal mass	Renal and urinary disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Renal pain	Renal and urinary disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Renal tubular necrosis	Renal and urinary disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Stress urinary incontinence	Renal and urinary disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0011 events1 affected8,869 at risk
Urethral obstruction	Renal and urinary disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Urethral polyp	Renal and urinary disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Urethral stenosis	Renal and urinary disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0003 events3 affected8,864 at risk EG0010 events0 affected8,869 at risk
Urinary bladder haemorrhage	Renal and urinary disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0010 events0 affected8,869 at risk
Urinary bladder polyp	Renal and urinary disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Urinary retention	Renal and urinary disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0005 events5 affected8,864 at risk EG0017 events7 affected8,869 at risk
Urinary tract obstruction	Renal and urinary disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0012 events2 affected8,869 at risk
Vesical fistula	Renal and urinary disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA MedDRA14.0	Systematic Assessment	EG00017 events17 affected8,864 at risk EG00112 events12 affected8,869 at risk
Cervical polyp	Reproductive system and breast disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Cystocele	Reproductive system and breast disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0003 events3 affected8,864 at risk EG0010 events0 affected8,869 at risk
Endometrial hypertrophy	Reproductive system and breast disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Epididymitis	Reproductive system and breast disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Erectile dysfunction	Reproductive system and breast disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0012 events2 affected8,869 at risk
Female genital tract fistula	Reproductive system and breast disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Genital cyst	Reproductive system and breast disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0013 events3 affected8,869 at risk
Ovarian mass	Reproductive system and breast disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Pelvic pain	Reproductive system and breast disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Postmenopausal haemorrhage	Reproductive system and breast disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Prostatic disorder	Reproductive system and breast disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0011 events1 affected8,869 at risk
Prostatism	Reproductive system and breast disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0012 events2 affected8,869 at risk
Prostatomegaly	Reproductive system and breast disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0005 events5 affected8,864 at risk EG0013 events3 affected8,869 at risk
Rectocele	Reproductive system and breast disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0011 events1 affected8,869 at risk
Testicular swelling	Reproductive system and breast disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Uterine cervical erosion	Reproductive system and breast disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Uterine polyp	Reproductive system and breast disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Uterine prolapse	Reproductive system and breast disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0004 events4 affected8,864 at risk EG0017 events7 affected8,869 at risk
Uterovaginal prolapse	Reproductive system and breast disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Vaginal fistula	Reproductive system and breast disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Vaginal prolapse	Reproductive system and breast disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0010 events0 affected8,869 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0010 events0 affected8,869 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0010 events0 affected8,869 at risk
Alveolitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0010 events0 affected8,869 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0003 events3 affected8,864 at risk EG0016 events6 affected8,869 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0011 events1 affected8,869 at risk
Bronchitis chronic	Respiratory, thoracic and mediastinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0011 events1 affected8,869 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0013 events3 affected8,869 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG00033 events33 affected8,864 at risk EG00125 events25 affected8,869 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0010 events0 affected8,869 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0006 events6 affected8,864 at risk EG0018 events8 affected8,869 at risk
Emphysema	Respiratory, thoracic and mediastinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0005 events5 affected8,864 at risk EG0010 events0 affected8,869 at risk
Eosinophilic pneumonia chronic	Respiratory, thoracic and mediastinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0014 events4 affected8,869 at risk
Foreign body aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0011 events1 affected8,869 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Hydrothorax	Respiratory, thoracic and mediastinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Hypoventilation	Respiratory, thoracic and mediastinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0012 events2 affected8,869 at risk
Idiopathic pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0013 events3 affected8,869 at risk
Laryngeal leukoplakia	Respiratory, thoracic and mediastinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Nasal polyps	Respiratory, thoracic and mediastinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0013 events3 affected8,869 at risk
Obstructive airways disorder	Respiratory, thoracic and mediastinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Pharyngolaryngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0007 events7 affected8,864 at risk EG0014 events4 affected8,869 at risk
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0011 events1 affected8,869 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0007 events7 affected8,864 at risk EG0014 events4 affected8,869 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG00014 events14 affected8,864 at risk EG00111 events11 affected8,869 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0003 events3 affected8,864 at risk EG0010 events0 affected8,869 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0004 events4 affected8,864 at risk EG0010 events0 affected8,869 at risk
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0011 events1 affected8,869 at risk
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0011 events1 affected8,869 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0011 events1 affected8,869 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG00012 events12 affected8,864 at risk EG00112 events12 affected8,869 at risk
Sinus disorder	Respiratory, thoracic and mediastinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0011 events1 affected8,869 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0012 events2 affected8,869 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0012 events2 affected8,869 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Dermatitis exfoliative	Skin and subcutaneous tissue disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Facial hemiatrophy	Skin and subcutaneous tissue disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Skin disorder	Skin and subcutaneous tissue disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Skin nodule	Skin and subcutaneous tissue disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0012 events2 affected8,869 at risk
Stevens-Johnson syndrome	Skin and subcutaneous tissue disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Telangiectasia	Skin and subcutaneous tissue disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Cholecystectomy	Surgical and medical procedures	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Hip arthroplasty	Surgical and medical procedures	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Pancreatectomy	Surgical and medical procedures	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Aortic aneurysm	Vascular disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0005 events5 affected8,864 at risk EG0013 events3 affected8,869 at risk
Aortic aneurysm rupture	Vascular disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Aortic dissection	Vascular disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Aortic stenosis	Vascular disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0014 events4 affected8,869 at risk
Arterial occlusive disease	Vascular disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Arterial thrombosis limb	Vascular disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Arteriosclerosis	Vascular disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0011 events1 affected8,869 at risk
Circulatory collapse	Vascular disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0012 events2 affected8,869 at risk
Deep vein thrombosis	Vascular disorders	MedDRA MedDRA14.0	Systematic Assessment	EG00013 events13 affected8,864 at risk EG0017 events7 affected8,869 at risk
Embolism	Vascular disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0011 events1 affected8,869 at risk
Haematoma	Vascular disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0003 events3 affected8,864 at risk EG0012 events2 affected8,869 at risk
Hypertension	Vascular disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0007 events7 affected8,864 at risk EG0019 events9 affected8,869 at risk
Hypertensive crisis	Vascular disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0012 events2 affected8,869 at risk
Hypertensive emergency	Vascular disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Hypotension	Vascular disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0010 events0 affected8,869 at risk
Hypovolaemic shock	Vascular disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0011 events1 affected8,869 at risk
Intermittent claudication	Vascular disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0010 events0 affected8,869 at risk
Lymphoedema	Vascular disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Orthostatic hypotension	Vascular disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0010 events0 affected8,869 at risk
Peripheral artery aneurysm	Vascular disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0012 events2 affected8,869 at risk
Peripheral embolism	Vascular disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Peripheral ischaemia	Vascular disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Phlebitis	Vascular disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0011 events1 affected8,869 at risk
Thrombophlebitis	Vascular disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0012 events2 affected8,869 at risk
Thrombosis	Vascular disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk
Varicose vein	Vascular disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0002 events2 affected8,864 at risk EG0012 events2 affected8,869 at risk
Vascular pseudoaneurysm	Vascular disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0000 events0 affected8,864 at risk EG0012 events2 affected8,869 at risk
Venous thrombosis	Vascular disorders	MedDRA MedDRA14.0	Systematic Assessment	EG0001 events1 affected8,864 at risk EG0010 events0 affected8,869 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Bronchitis	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG000571 events571 affected8,864 at risk EG001596 events596 affected8,869 at risk
Nasopharyngitis	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG000607 events607 affected8,864 at risk EG001632 events632 affected8,869 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG000637 events637 affected8,864 at risk EG001580 events580 affected8,869 at risk
Urinary tract infection	Infections and infestations	MedDRA MedDRA14.0	Systematic Assessment	EG000686 events686 affected8,864 at risk EG001699 events699 affected8,869 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA MedDRA14.0	Systematic Assessment	EG000576 events576 affected8,864 at risk EG001631 events631 affected8,869 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA MedDRA14.0	Systematic Assessment	EG000559 events559 affected8,864 at risk EG001653 events653 affected8,869 at risk
Hypertension	Vascular disorders	MedDRA MedDRA14.0	Systematic Assessment	EG000628 events628 affected8,864 at risk EG001557 events557 affected8,869 at risk

Ancestor Terms

ID	Term
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals
D005464	Fluorobenzenes
D006845	Hydrocarbons, Fluorinated
D006846	Hydrocarbons, Halogenated
D006838	Hydrocarbons
D013450	Sulfones
D013457	Sulfur Compounds
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

ID	Title	Description
BG000	Rosuvastatin	Rosuvastatin 20 mg once daily
BG001	Placebo	Placebo once daily
BG002	Total	Total of all reporting groups

ID	Type	Description	Link
Jupiter
4522US/0011