Irbesartan in Heart Failure With Preserved Systolic Funct... | NCT00095238

Name	Class
Sanofi	INDUSTRY

Label	Type	Description	Intervention Names
1	Active Comparator		Drug: Irbesartan
2	Placebo Comparator		Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Irbesartan	Drug	Tablets, Oral, titration from 75 to 300 mg, once daily up to 6 years	1

Measure	Description	Time Frame
Percentage of Participants With First Occurrence of the Composite Outcome of Death (All Cause) or Protocol-Specified Cardiovascular (CV) Hospitalization at Given Timepoints	Treatment comparisons for time to first occurrence of composite outcome of all-cause death (composite outcome of death) or protocol-specified CV hospitalization. Protocol-specified CV hospitalizations include those ≥24 hrs or involving a calendar date change for a primary cause of worsening heart failure, unstable angina, myocardial infarction, ventricular or atrial dysrhythmia, or stroke, that also require intravenous or intramuscular therapy or a related procedure or significant augmentation of oral therapy. In addition, MI or stroke during any hospitalization are included.	Year 1, Year 2, Year 3, Year 4, Year 5

Measure	Description	Time Frame
Percentage of Participants Experiencing Heart Failure Mortality or Heart Failure Hospitalization at Given Time Points	Treatment comparisons for time to heart failure mortality or heart failure hospitalization	Year 1, Year 2, Year 3, Year 4, Year 5
Minnesota Living With Heart Failure (MLwHF) Total Score (Sum of Questions 1-21) at Month 6 and Month 14

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution		Birmingham	Alabama		United States
Local Institution

PubMed Identifier	Type	Citation	Retractions
19001508	Result	Massie BM, Carson PE, McMurray JJ, Komajda M, McKelvie R, Zile MR, Anderson S, Donovan M, Iverson E, Staiger C, Ptaszynska A; I-PRESERVE Investigators. Irbesartan in patients with heart failure and preserved ejection fraction. N Engl J Med. 2008 Dec 4;359(23):2456-67. doi: 10.1056/NEJMoa0805450. Epub 2008 Nov 11.
20231531	Result

ID	Title	Description
FG000	Irbesartan	titration from 75 to 300 mg, once daily (QD), up to 6 years
FG001	Placebo	titration from 75 to 300 mg, once daily (QD), up to 6 years

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
CATARACT	Eye disorders	MedDRA 11.0	Systematic Assessment	EG00016 affected2,064 at risk EG00110 affected2,062 at risk
DIPLOPIA	Eye disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
GLAUCOMA	Eye disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0013 affected2,062 at risk
MACULOPATHY	Eye disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0012 affected2,062 at risk
RETINOPATHY	Eye disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
IRIDOCYCLITIS	Eye disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
VISION BLURRED	Eye disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0012 affected2,062 at risk
MACULAR RUPTURE	Eye disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
ATROPHY OF GLOBE	Eye disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
RETINAL DETACHMENT	Eye disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0011 affected2,062 at risk
BLINDNESS UNILATERAL	Eye disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
CORNEAL DEGENERATION	Eye disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
DIABETIC RETINOPATHY	Eye disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0011 affected2,062 at risk
MACULAR DEGENERATION	Eye disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
ULCERATIVE KERATITIS	Eye disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
VITREOUS HAEMORRHAGE	Eye disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
VISUAL ACUITY REDUCED	Eye disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
RETINAL VEIN OCCLUSION	Eye disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
RETINAL ARTERY EMBOLISM	Eye disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
CONJUNCTIVAL HAEMORRHAGE	Eye disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
ANGIOGRAM	Investigations	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
WEIGHT DECREASED	Investigations	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0014 affected2,062 at risk
TROPONIN INCREASED	Investigations	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
BLOOD URINE PRESENT	Investigations	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
BLOOD UREA INCREASED	Investigations	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
CHEST X-RAY ABNORMAL	Investigations	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
HAEMOGLOBIN ABNORMAL	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
HEART RATE INCREASED	Investigations	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0012 affected2,062 at risk
BLOOD GLUCOSE ABNORMAL	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
BLOOD ALCOHOL INCREASED	Investigations	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
BLOOD GLUCOSE INCREASED	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0013 affected2,062 at risk
BLOOD PRESSURE INCREASED	Investigations	MedDRA 11.0	Systematic Assessment	EG0004 affected2,064 at risk EG0015 affected2,062 at risk
ELECTROCARDIOGRAM CHANGE	Investigations	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0012 affected2,062 at risk
BLOOD POTASSIUM DECREASED	Investigations	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
BLOOD POTASSIUM INCREASED	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0011 affected2,062 at risk
BLOOD CREATININE INCREASED	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0012 affected2,062 at risk
COAGULATION TIME PROLONGED	Investigations	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
ELECTROCARDIOGRAM ABNORMAL	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
PROTHROMBIN TIME PROLONGED	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
RESPIRATORY RATE DECREASED	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
CARCINOEMBRYONIC ANTIGEN INCREASED	Investigations	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
SCAN MYOCARDIAL PERFUSION ABNORMAL	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
BLOOD PRESSURE ORTHOSTATIC ABNORMAL	Investigations	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
PULMONARY ARTERIAL PRESSURE INCREASED	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
INTERNATIONAL NORMALISED RATIO INCREASED	Investigations	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0014 affected2,062 at risk
ARRHYTHMIA	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG00015 affected2,064 at risk EG00111 affected2,062 at risk
BRADYCARDIA	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG00014 affected2,064 at risk EG00113 affected2,062 at risk
TACHYCARDIA	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG00010 affected2,064 at risk EG0014 affected2,062 at risk
PALPITATIONS	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0015 affected2,062 at risk
PERICARDITIS	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0013 affected2,062 at risk
SINUS ARREST	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
ATRIAL FLUTTER	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG00015 affected2,064 at risk EG00111 affected2,062 at risk
CARDIAC ARREST	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0009 affected2,064 at risk EG0019 affected2,062 at risk
CARDIAC ASTHMA	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0017 affected2,062 at risk
ANGINA PECTORIS	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG00059 affected2,064 at risk EG00161 affected2,062 at risk
ANGINA UNSTABLE	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG00086 affected2,064 at risk EG00178 affected2,062 at risk
BRADYARRHYTHMIA	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0012 affected2,062 at risk
CARDIAC FAILURE	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG000274 affected2,064 at risk EG001275 affected2,062 at risk
TACHYARRHYTHMIA	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0012 affected2,062 at risk
CARDIAC DISORDER	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected2,064 at risk EG0011 affected2,062 at risk
NODAL ARRHYTHMIA	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0012 affected2,062 at risk
SINOATRIAL BLOCK	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0012 affected2,062 at risk
SINUS ARRHYTHMIA	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
CARDIAC TAMPONADE	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
CARDIOGENIC SHOCK	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0005 affected2,064 at risk EG0016 affected2,062 at risk
SINUS BRADYCARDIA	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0005 affected2,064 at risk EG0011 affected2,062 at risk
SINUS TACHYCARDIA	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
ATRIAL TACHYCARDIA	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0010 affected2,062 at risk
BIFASCICULAR BLOCK	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
ATRIAL FIBRILLATION	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG000105 affected2,064 at risk EG001104 affected2,062 at risk
BUNDLE BRANCH BLOCK	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
CARDIAC HYPERTROPHY	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
CONDUCTION DISORDER	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
DRESSLER'S SYNDROME	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
SICK SINUS SYNDROME	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0005 affected2,064 at risk EG00115 affected2,062 at risk
AORTIC VALVE DISEASE	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0012 affected2,062 at risk
MYOCARDIAL ISCHAEMIA	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG00012 affected2,064 at risk EG00110 affected2,062 at risk
PERICARDIAL EFFUSION	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
ADAMS-STOKES SYNDROME	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
AORTIC VALVE STENOSIS	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0006 affected2,064 at risk EG0012 affected2,062 at risk
ARTERIOSPASM CORONARY	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
CARDIAC FAILURE ACUTE	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0005 affected2,064 at risk EG0012 affected2,062 at risk
CARDIAC VALVE DISEASE	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
INTRACARDIAC THROMBUS	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
MITRAL VALVE PROLAPSE	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
MITRAL VALVE STENOSIS	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG00042 affected2,064 at risk EG00147 affected2,062 at risk
PAROXYSMAL ARRHYTHMIA	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
ATRIOVENTRICULAR BLOCK	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0017 affected2,062 at risk
VENTRICULAR ARRHYTHMIA	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0011 affected2,062 at risk
ACUTE CORONARY SYNDROME	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG00015 affected2,064 at risk EG00114 affected2,062 at risk
CARDIAC FAILURE CHRONIC	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0011 affected2,062 at risk
CARDIOPULMONARY FAILURE	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0011 affected2,062 at risk
CARDIOVASCULAR DISORDER	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0012 affected2,062 at risk
CORONARY ARTERY DISEASE	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG00016 affected2,064 at risk EG00115 affected2,062 at risk
PERICARDIAL HAEMORRHAGE	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
VENTRICULAR DYSFUNCTION	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
VENTRICULAR TACHYCARDIA	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0008 affected2,064 at risk EG00110 affected2,062 at risk
BUNDLE BRANCH BLOCK LEFT	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0012 affected2,062 at risk
CHORDAE TENDINAE RUPTURE	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
CORONARY ARTERY STENOSIS	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0005 affected2,064 at risk EG0012 affected2,062 at risk
CORONARY OSTIAL STENOSIS	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
ISCHAEMIC CARDIOMYOPATHY	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
LEFT VENTRICULAR FAILURE	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected2,064 at risk EG0016 affected2,062 at risk
VENTRICULAR FIBRILLATION	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0016 affected2,062 at risk
AORTIC VALVE INCOMPETENCE	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0011 affected2,062 at risk
BUNDLE BRANCH BLOCK RIGHT	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0011 affected2,062 at risk
CARDIO-RESPIRATORY ARREST	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0005 affected2,064 at risk EG0017 affected2,062 at risk
CORONARY ARTERY OCCLUSION	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0012 affected2,062 at risk
MITRAL VALVE INCOMPETENCE	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected2,064 at risk EG0011 affected2,062 at risk
RIGHT VENTRICULAR FAILURE	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected2,064 at risk EG0012 affected2,062 at risk
VENTRICULAR EXTRASYSTOLES	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0012 affected2,062 at risk
CARDIAC FAILURE CONGESTIVE	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG00055 affected2,064 at risk EG00161 affected2,062 at risk
CORONARY ARTERY DISSECTION	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
HYPERTENSIVE HEART DISEASE	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
ACUTE MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG00039 affected2,064 at risk EG00133 affected2,062 at risk
LEFT VENTRICULAR DYSFUNCTION	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
LEFT VENTRICULAR HYPERTROPHY	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
SILENT MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0010 affected2,062 at risk
SUPRAVENTRICULAR TACHYCARDIA	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0005 affected2,064 at risk EG00110 affected2,062 at risk
CARDIOVASCULAR DECONDITIONING	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
CORONARY ARTERY INSUFFICIENCY	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected2,064 at risk EG0010 affected2,062 at risk
ATRIOVENTRICULAR BLOCK COMPLETE	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG00011 affected2,064 at risk EG0018 affected2,062 at risk
ARTERIOSCLEROSIS CORONARY ARTERY	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected2,064 at risk EG0010 affected2,062 at risk
SUPRAVENTRICULAR TACHYARRHYTHMIA	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
ATRIOVENTRICULAR BLOCK FIRST DEGREE	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0011 affected2,062 at risk
ATRIOVENTRICULAR BLOCK SECOND DEGREE	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0014 affected2,062 at risk
SHOCK	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0012 affected2,062 at risk
EMBOLISM	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0012 affected2,062 at risk
ARTERITIS	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
HAEMATOMA	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0006 affected2,064 at risk EG0013 affected2,062 at risk
ISCHAEMIA	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0016 affected2,062 at risk
PHLEBITIS	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0012 affected2,062 at risk
INFARCTION	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
THROMBOSIS	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0012 affected2,062 at risk
HAEMORRHAGE	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0011 affected2,062 at risk
HYPOTENSION	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG00025 affected2,064 at risk EG00120 affected2,062 at risk
HYPERTENSION	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG00033 affected2,064 at risk EG00135 affected2,062 at risk
VARICOSE VEIN	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0014 affected2,062 at risk
ANGIOSCLEROSIS	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
AORTIC ANEURYSM	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected2,064 at risk EG0013 affected2,062 at risk
AORTIC STENOSIS	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0005 affected2,064 at risk EG0015 affected2,062 at risk
ARTERIAL RUPTURE	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
ARTERIOSCLEROSIS	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected2,064 at risk EG0011 affected2,062 at risk
THROMBOPHLEBITIS	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0011 affected2,062 at risk
ANEURYSM RUPTURED	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0012 affected2,062 at risk
VENOUS THROMBOSIS	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0012 affected2,062 at risk
EXTREMITY NECROSIS	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
HYPOVOLAEMIC SHOCK	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0013 affected2,062 at risk
SHOCK HAEMORRHAGIC	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
TEMPORAL ARTERITIS	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
HYPERTENSIVE CRISIS	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG00010 affected2,064 at risk EG0018 affected2,062 at risk
PERIPHERAL EMBOLISM	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0005 affected2,064 at risk EG0012 affected2,062 at risk
VARICOSE ULCERATION	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
ARTERIAL HAEMORRHAGE	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
CIRCULATORY COLLAPSE	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0007 affected2,064 at risk EG0014 affected2,062 at risk
DEEP VEIN THROMBOSIS	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected2,064 at risk EG0013 affected2,062 at risk
PERIPHERAL ISCHAEMIA	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0007 affected2,064 at risk EG0014 affected2,062 at risk
ILIAC ARTERY STENOSIS	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0011 affected2,062 at risk
ARTERIAL INSUFFICIENCY	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
ARTERIAL STENOSIS LIMB	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0013 affected2,062 at risk
ESSENTIAL HYPERTENSION	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
HYPERTENSIVE EMERGENCY	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
VASCULAR INSUFFICIENCY	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0010 affected2,062 at risk
VENOUS THROMBOSIS LIMB	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
AORTIC ANEURYSM RUPTURE	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
ORTHOSTATIC HYPOTENSION	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected2,064 at risk EG0014 affected2,062 at risk
VASCULAR PSEUDOANEURYSM	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
ARTERIAL THROMBOSIS LIMB	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0011 affected2,062 at risk
FEMORAL ARTERY OCCLUSION	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected2,064 at risk EG0011 affected2,062 at risk
FEMORAL ARTERIAL STENOSIS	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
INTERMITTENT CLAUDICATION	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0005 affected2,064 at risk EG0014 affected2,062 at risk
ARTERIAL OCCLUSIVE DISEASE	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0011 affected2,062 at risk
DIABETIC VASCULAR DISORDER	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
ARTERIOSCLEROSIS OBLITERANS	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0013 affected2,062 at risk
VISCERAL ARTERIAL ISCHAEMIA	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
CARDIOVASCULAR INSUFFICIENCY	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
PERIPHERAL VASCULAR DISORDER	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0005 affected2,064 at risk EG0013 affected2,062 at risk
THROMBOPHLEBITIS SUPERFICIAL	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0012 affected2,062 at risk
GOITRE	Endocrine disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected2,064 at risk EG0015 affected2,062 at risk
THYROIDITIS	Endocrine disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
HYPOTHYROIDISM	Endocrine disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected2,064 at risk EG0011 affected2,062 at risk
HYPERTHYROIDISM	Endocrine disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0011 affected2,062 at risk
THYROID DISORDER	Endocrine disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
BASEDOW'S DISEASE	Endocrine disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
HYPERPARATHYROIDISM	Endocrine disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
SOPOR	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
STRESS	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
ANXIETY	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected2,064 at risk EG0012 affected2,062 at risk
DELIRIUM	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0011 affected2,062 at risk
AGITATION	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
ALCOHOLISM	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
DEPRESSION	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0009 affected2,064 at risk EG0016 affected2,062 at risk
NERVOUSNESS	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
PANIC ATTACK	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
ALCOHOL ABUSE	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0011 affected2,062 at risk
HALLUCINATION	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
DISORIENTATION	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0011 affected2,062 at risk
SLEEP DISORDER	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
DRUG DEPENDENCE	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0011 affected2,062 at risk
SUICIDE ATTEMPT	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected2,064 at risk EG0010 affected2,062 at risk
COMPLETED SUICIDE	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0011 affected2,062 at risk
CONFUSIONAL STATE	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0007 affected2,064 at risk EG0013 affected2,062 at risk
ABNORMAL BEHAVIOUR	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
DYSTHYMIC DISORDER	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
ADJUSTMENT DISORDER	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
PERSONALITY DISORDER	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
MENTAL STATUS CHANGES	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
SOCIAL AVOIDANT BEHAVIOUR	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
ALCOHOL WITHDRAWAL SYNDROME	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
OBSESSIVE-COMPULSIVE DISORDER	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
JAUNDICE	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0013 affected2,062 at risk
HEPATITIS	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0012 affected2,062 at risk
CHOLANGITIS	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0012 affected2,062 at risk
CHOLESTASIS	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0011 affected2,062 at risk
BILIARY COLIC	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0011 affected2,062 at risk
CHOLECYSTITIS	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG00012 affected2,064 at risk EG0018 affected2,062 at risk
CHOLELITHIASIS	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG00021 affected2,064 at risk EG00125 affected2,062 at risk
LIVER DISORDER	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0011 affected2,062 at risk
BILE DUCT STONE	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0014 affected2,062 at risk
BILIARY FISTULA	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
HEPATIC FAILURE	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0012 affected2,062 at risk
HEPATITIS ACUTE	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
HEPATITIS TOXIC	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
HYDROCHOLECYSTIS	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
CARDIAC CIRRHOSIS	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
HEPATIC CIRRHOSIS	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected2,064 at risk EG0013 affected2,062 at risk
BILIARY DYSKINESIA	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
CHOLECYSTITIS ACUTE	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG0005 affected2,064 at risk EG0013 affected2,062 at risk
GALLBLADDER DISORDER	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
HEPATORENAL SYNDROME	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
JAUNDICE CHOLESTATIC	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
ACUTE HEPATIC FAILURE	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
CHOLECYSTITIS CHRONIC	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected2,064 at risk EG0012 affected2,062 at risk
HEPATITIS CHOLESTATIC	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
AMPULLA OF VATER STENOSIS	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
HEPATIC FUNCTION ABNORMAL	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
AMYLOIDOSIS	Immune system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
SARCOIDOSIS	Immune system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
IODINE ALLERGY	Immune system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
HYPERSENSITIVITY	Immune system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0012 affected2,062 at risk
ANAPHYLACTIC REACTION	Immune system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
DRUG HYPERSENSITIVITY	Immune system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
COMA	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
TREMOR	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
SYNCOPE	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG00036 affected2,064 at risk EG00141 affected2,062 at risk
DEMENTIA	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0013 affected2,062 at risk
EPILEPSY	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0011 affected2,062 at risk
HEADACHE	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0015 affected2,062 at risk
SCIATICA	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected2,064 at risk EG0012 affected2,062 at risk
DIZZINESS	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0009 affected2,064 at risk EG00112 affected2,062 at risk
HYPOTONIA	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
NEURALGIA	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
CONVULSION	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0014 affected2,062 at risk
DYSARTHRIA	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
HEMIPLEGIA	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0012 affected2,062 at risk
HYPERTONIA	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected2,064 at risk EG0011 affected2,062 at risk
MONOPLEGIA	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
PRESYNCOPE	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0005 affected2,064 at risk EG0014 affected2,062 at risk
SOMNOLENCE	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
HEMIPARESIS	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0012 affected2,062 at risk
MONOPARESIS	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
BRAIN INJURY	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0010 affected2,062 at risk
DROP ATTACKS	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
DYSAESTHESIA	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
PARAESTHESIA	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0012 affected2,062 at risk
SENSORY LOSS	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
HYPOAESTHESIA	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
EMBOLIC STROKE	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
ENCEPHALOPATHY	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected2,064 at risk EG0013 affected2,062 at risk
FACIAL PARESIS	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0011 affected2,062 at risk
GLOBAL AMNESIA	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
POLYNEUROPATHY	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
BALANCE DISORDER	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0010 affected2,062 at risk
CEREBROSCLEROSIS	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
ISCHAEMIC STROKE	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG00014 affected2,064 at risk EG00125 affected2,062 at risk
PARTIAL SEIZURES	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
SPINAL HAEMATOMA	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
MENTAL IMPAIRMENT	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0011 affected2,062 at risk
MOTOR DYSFUNCTION	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
MYASTHENIA GRAVIS	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
SYNCOPE VASOVAGAL	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0010 affected2,062 at risk
VASCULAR DEMENTIA	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
CEREBRAL ISCHAEMIA	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0005 affected2,064 at risk EG0012 affected2,062 at risk
COGNITIVE DISORDER	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
MULTIPLE SCLEROSIS	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
RADICULAR SYNDROME	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
CEREBRAL INFARCTION	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected2,064 at risk EG0012 affected2,062 at risk
DIABETIC NEUROPATHY	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0013 affected2,062 at risk
HAEMORRHAGIC STROKE	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0005 affected2,064 at risk EG0014 affected2,062 at risk
PARKINSON'S DISEASE	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0011 affected2,062 at risk
SPINAL CLAUDICATION	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
WALLENBERG SYNDROME	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
CEREBELLAR HAEMATOMA	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
CEREBRAL HAEMORRHAGE	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0012 affected2,062 at risk
GRAND MAL CONVULSION	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
TOXIC ENCEPHALOPATHY	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
COORDINATION ABNORMAL	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
INTRACRANIAL ANEURYSM	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
LOSS OF CONSCIOUSNESS	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected2,064 at risk EG0012 affected2,062 at risk
CARPAL TUNNEL SYNDROME	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0012 affected2,062 at risk
HEPATIC ENCEPHALOPATHY	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
INTRACRANIAL HAEMATOMA	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
CAROTID ARTERY STENOSIS	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0007 affected2,064 at risk EG0015 affected2,062 at risk
SPINAL CORD COMPRESSION	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected2,064 at risk EG0012 affected2,062 at risk
VASCULAR ENCEPHALOPATHY	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected2,064 at risk EG0012 affected2,062 at risk
CAROTID ARTERY OCCLUSION	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
CEREBROVASCULAR ACCIDENT	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG00056 affected2,064 at risk EG00170 affected2,062 at risk
CEREBROVASCULAR DISORDER	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0012 affected2,062 at risk
HAEMORRHAGE INTRACRANIAL	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0010 affected2,062 at risk
SUBARACHNOID HAEMORRHAGE	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0012 affected2,062 at risk
CEREBRAL ARTERIOSCLEROSIS	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected2,064 at risk EG0010 affected2,062 at risk
TRANSIENT ISCHAEMIC ATTACK	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG00022 affected2,064 at risk EG00125 affected2,062 at risk
HYPERTENSIVE ENCEPHALOPATHY	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
INTRAVENTRICULAR HAEMORRHAGE	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
CEREBROVASCULAR INSUFFICIENCY	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
ISCHAEMIC CEREBRAL INFARCTION	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
VERTEBROBASILAR INSUFFICIENCY	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected2,064 at risk EG0010 affected2,062 at risk
ALTERED STATE OF CONSCIOUSNESS	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
DEPRESSED LEVEL OF CONSCIOUSNESS	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0010 affected2,062 at risk
HAEMORRHAGIC CEREBRAL INFARCTION	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
ILEUS	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected2,064 at risk EG0012 affected2,062 at risk
NAUSEA	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected2,064 at risk EG00110 affected2,062 at risk
APHAGIA	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
ASCITES	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected2,064 at risk EG0012 affected2,062 at risk
COLITIS	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected2,064 at risk EG0015 affected2,062 at risk
MELAENA	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected2,064 at risk EG0013 affected2,062 at risk
SUBILEUS	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0011 affected2,062 at risk
VOLVULUS	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
VOMITING	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0007 affected2,064 at risk EG0018 affected2,062 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0008 affected2,064 at risk EG0016 affected2,062 at risk
DYSPEPSIA	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected2,064 at risk EG0010 affected2,062 at risk
ENTERITIS	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected2,064 at risk EG0010 affected2,062 at risk
FAECALOMA	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0010 affected2,062 at risk
GASTRITIS	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0007 affected2,064 at risk EG0016 affected2,062 at risk
DUODENITIS	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
PERITONITIS	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0010 affected2,062 at risk
SIGMOIDITIS	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
ANAL FISSURE	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
ANAL FISTULA	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
CONSTIPATION	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0014 affected2,062 at risk
DIVERTICULUM	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0012 affected2,062 at risk
HAEMATEMESIS	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected2,064 at risk EG0011 affected2,062 at risk
HAEMORRHOIDS	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0011 affected2,062 at risk
OESOPHAGITIS	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0011 affected2,062 at risk
PANCREATITIS	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0016 affected2,062 at risk
PEPTIC ULCER	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0012 affected2,062 at risk
RECTAL POLYP	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
ACUTE ABDOMEN	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0010 affected2,062 at risk
COLONIC POLYP	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0013 affected2,062 at risk
DENTAL CARIES	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
GASTRIC ULCER	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0005 affected2,064 at risk EG0014 affected2,062 at risk
HAEMATOCHEZIA	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
HIATUS HERNIA	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0012 affected2,062 at risk
ABDOMINAL MASS	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0011 affected2,062 at risk
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG00019 affected2,064 at risk EG00117 affected2,062 at risk
DUODENAL ULCER	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected2,064 at risk EG0015 affected2,062 at risk
FEMORAL HERNIA	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
GASTRIC POLYPS	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0011 affected2,062 at risk
CROHN'S DISEASE	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
ILEUS PARALYTIC	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
INGUINAL HERNIA	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0007 affected2,064 at risk EG0019 affected2,062 at risk
INTESTINAL MASS	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
ABDOMINAL HERNIA	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0013 affected2,062 at risk
DUODENAL FISTULA	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
INTESTINAL POLYP	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0010 affected2,062 at risk
MECHANICAL ILEUS	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
SPIGELIAN HERNIA	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
UMBILICAL HERNIA	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0005 affected2,064 at risk EG0010 affected2,062 at risk
COLITIS ISCHAEMIC	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0010 affected2,062 at risk
GASTRITIS EROSIVE	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0005 affected2,064 at risk EG0013 affected2,062 at risk
COLITIS ULCERATIVE	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0012 affected2,062 at risk
EROSIVE DUODENITIS	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
PANCREATITIS ACUTE	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected2,064 at risk EG0012 affected2,062 at risk
RECTAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0007 affected2,064 at risk EG0016 affected2,062 at risk
COLONIC OBSTRUCTION	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0010 affected2,062 at risk
GASTRIC HAEMORRHAGE	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0012 affected2,062 at risk
PANCREATIC NECROSIS	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0010 affected2,062 at risk
ABDOMINAL DISCOMFORT	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0012 affected2,062 at risk
ABDOMINAL PAIN LOWER	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0005 affected2,064 at risk EG0012 affected2,062 at risk
MESENTERIC OCCLUSION	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
PANCREATITIS CHRONIC	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected2,064 at risk EG0011 affected2,062 at risk
INTESTINAL INFARCTION	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0010 affected2,062 at risk
GASTRITIS HAEMORRHAGIC	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected2,064 at risk EG0011 affected2,062 at risk
INTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0011 affected2,062 at risk
INTESTINAL OBSTRUCTION	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected2,064 at risk EG0016 affected2,062 at risk
LARGE INTESTINAL ULCER	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
MALLORY-WEISS SYNDROME	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
DIVERTICULUM INTESTINAL	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0016 affected2,062 at risk
IRRITABLE BOWEL SYNDROME	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
PEPTIC ULCER HAEMORRHAGE	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
GASTRIC ULCER HAEMORRHAGE	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
GASTRIC ULCER PERFORATION	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0010 affected2,062 at risk
GASTROINTESTINAL DISORDER	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected2,064 at risk EG0011 affected2,062 at risk
HAEMORRHOIDAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
INTRA-ABDOMINAL HAEMATOMA	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
PANCREATITIS HAEMORRHAGIC	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
PAPILLA OF VATER STENOSIS	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0012 affected2,062 at risk
DUODENAL ULCER HAEMORRHAGE	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
GASTROINTESTINAL ISCHAEMIA	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
HIATUS HERNIA, OBSTRUCTIVE	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
BOWEL MOVEMENT IRREGULARITY	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
FEMORAL HERNIA, OBSTRUCTIVE	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
INTRA-ABDOMINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
LARGE INTESTINE PERFORATION	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0012 affected2,062 at risk
RETROPERITONEAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
ABDOMINAL HERNIA OBSTRUCTIVE	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG00021 affected2,064 at risk EG00115 affected2,062 at risk
INGUINAL HERNIA, OBSTRUCTIVE	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0012 affected2,062 at risk
LARGE INTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
SMALL INTESTINAL OBSTRUCTION	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0011 affected2,062 at risk
THROMBOSIS MESENTERIC VESSEL	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0013 affected2,062 at risk
ABDOMINAL STRANGULATED HERNIA	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0011 affected2,062 at risk
UMBILICAL HERNIA, OBSTRUCTIVE	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
OESOPHAGEAL VARICES HAEMORRHAGE	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0012 affected2,062 at risk
GASTROOESOPHAGEAL REFLUX DISEASE	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
LOWER GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0011 affected2,062 at risk
UPPER GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0006 affected2,064 at risk EG0016 affected2,062 at risk
DIVERTICULUM INTESTINAL HAEMORRHAGIC	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0011 affected2,062 at risk
VERTIGO	Ear and labyrinth disorders	MedDRA 11.0	Systematic Assessment	EG0009 affected2,064 at risk EG0018 affected2,062 at risk
DEAFNESS	Ear and labyrinth disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
TINNITUS	Ear and labyrinth disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
HYPOACUSIS	Ear and labyrinth disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
PRESBYACUSIS	Ear and labyrinth disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
MOTION SICKNESS	Ear and labyrinth disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0010 affected2,062 at risk
VERTIGO POSITIONAL	Ear and labyrinth disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0012 affected2,062 at risk
VESTIBULAR DISORDER	Ear and labyrinth disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
DEAFNESS NEUROSENSORY	Ear and labyrinth disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
SEPSIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0009 affected2,064 at risk EG00115 affected2,062 at risk
ABSCESS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0011 affected2,062 at risk
CYSTITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0013 affected2,062 at risk
FURUNCLE	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
GANGRENE	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0003 affected2,064 at risk EG0012 affected2,062 at risk
MASTITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
RHINITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
CARBUNCLE	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
INFLUENZA	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0010 affected2,062 at risk
PAROTITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
PNEUMONIA	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG00087 affected2,064 at risk EG00183 affected2,062 at risk
PYOTHORAX	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
SINUSITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
UROSEPSIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0009 affected2,064 at risk EG0017 affected2,062 at risk
BRONCHITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG00031 affected2,064 at risk EG00130 affected2,062 at risk
CELLULITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG00011 affected2,064 at risk EG00122 affected2,062 at risk
ERYSIPELAS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0008 affected2,064 at risk EG0019 affected2,062 at risk
LARYNGITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0012 affected2,062 at risk
PARONYCHIA	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0010 affected2,062 at risk
URETHRITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
ABSCESS JAW	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
BACTERAEMIA	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0011 affected2,062 at risk
PHARYNGITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0011 affected2,062 at risk
TONSILLITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
ABSCESS LIMB	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0013 affected2,062 at risk
APPENDICITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0014 affected2,062 at risk
ENDOCARDITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0014 affected2,062 at risk
OTITIS MEDIA	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
SEPTIC SHOCK	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0007 affected2,064 at risk EG0016 affected2,062 at risk
TUBERCULOSIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0013 affected2,062 at risk
BRONCHIOLITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
HERPES ZOSTER	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
OSTEOMYELITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0004 affected2,064 at risk EG0013 affected2,062 at risk
SALMONELLOSIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
DIVERTICULITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0004 affected2,064 at risk EG0018 affected2,062 at risk
LUNG INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0009 affected2,064 at risk EG00113 affected2,062 at risk
OTITIS EXTERNA	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0012 affected2,062 at risk
PYELONEPHRITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0003 affected2,064 at risk EG0011 affected2,062 at risk
SINOBRONCHITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
SUPERINFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
ACUTE SINUSITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
ECHINOCOCCIASIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
GASTROENTERITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG00013 affected2,064 at risk EG0018 affected2,062 at risk
LOBAR PNEUMONIA	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0004 affected2,064 at risk EG0012 affected2,062 at risk
PNEUMONIA VIRAL	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
TOOTH INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
VIRAL INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0010 affected2,062 at risk
WOUND INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0012 affected2,062 at risk
BRONCHITIS VIRAL	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
BRONCHOPNEUMONIA	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG00010 affected2,064 at risk EG0016 affected2,062 at risk
PERIANAL ABSCESS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
DIABETIC GANGRENE	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
TRACHEOBRONCHITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0011 affected2,062 at risk
CELLULITIS ORBITAL	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
ESCHERICHIA SEPSIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0011 affected2,062 at risk
ABSCESS SOFT TISSUE	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
ARTHRITIS BACTERIAL	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0010 affected2,062 at risk
FUNGAL OESOPHAGITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
INFECTED SKIN ULCER	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
LOCALISED INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0003 affected2,064 at risk EG0015 affected2,062 at risk
HERPES ZOSTER OTICUS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
NOSOCOMIAL INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
PERITONEAL INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
PYELONEPHRITIS ACUTE	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0011 affected2,062 at risk
SKIN GRAFT INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
STREPTOCOCCAL SEPSIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
SUBCUTANEOUS ABSCESS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0010 affected2,062 at risk
HAEMOPHILUS INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
PERITONSILLAR ABSCESS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
PSEUDOMONAS INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
SOFT TISSUE INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
SPINAL CORD INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
ABDOMINAL WALL ABSCESS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
ENDOCARDITIS BACTERIAL	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
INFECTED VARICOSE VEIN	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
PNEUMONIA PNEUMOCOCCAL	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
PULMONARY TUBERCULOSIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0012 affected2,062 at risk
PYELONEPHRITIS CHRONIC	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0013 affected2,062 at risk
OESOPHAGEAL CANDIDIASIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
PNEUMONIA STREPTOCOCCAL	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0011 affected2,062 at risk
RETROPERITONEAL ABSCESS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
STREPTOCOCCAL INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
URINARY TRACT INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG00024 affected2,064 at risk EG00132 affected2,062 at risk
HERPES ZOSTER OPHTHALMIC	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
STAPHYLOCOCCAL INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0003 affected2,064 at risk EG0010 affected2,062 at risk
PHARYNGITIS STREPTOCOCCAL	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
POST PROCEDURAL INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
GASTROINTESTINAL INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0008 affected2,064 at risk EG00112 affected2,062 at risk
CLOSTRIDIUM DIFFICILE COLITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
POSTOPERATIVE WOUND INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0012 affected2,062 at risk
LOWER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0004 affected2,064 at risk EG0014 affected2,062 at risk
RESPIRATORY TRACT INFECTION VIRAL	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0004 affected2,064 at risk EG0011 affected2,062 at risk
ESCHERICHIA URINARY TRACT INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
VIRAL UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
AZOTAEMIA	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0011 affected2,062 at risk
NEPHRITIS	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
HAEMATURIA	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0007 affected2,064 at risk EG0019 affected2,062 at risk
RENAL CYST	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0011 affected2,062 at risk
RENAL MASS	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
NEPHROPATHY	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
RENAL COLIC	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0012 affected2,062 at risk
BLADDER MASS	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
RENAL FAILURE	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG00032 affected2,064 at risk EG00130 affected2,062 at risk
HYDRONEPHROSIS	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0012 affected2,062 at risk
RENAL ANEURYSM	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
NEPHROLITHIASIS	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0015 affected2,062 at risk
NEPHROSCLEROSIS	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0010 affected2,062 at risk
BLADDER PROLAPSE	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
CALCULUS BLADDER	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
CALCULUS URINARY	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
RENAL IMPAIRMENT	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0006 affected2,064 at risk EG0015 affected2,062 at risk
CALCULUS URETERIC	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0013 affected2,062 at risk
NEPHROPATHY TOXIC	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
URINARY RETENTION	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected2,064 at risk EG0015 affected2,062 at risk
NEPHROTIC SYNDROME	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0010 affected2,062 at risk
RENAL FAILURE ACUTE	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG00021 affected2,064 at risk EG00110 affected2,062 at risk
URETERIC OBSTRUCTION	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
URINARY INCONTINENCE	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0010 affected2,062 at risk
CYSTITIS HAEMORRHAGIC	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0012 affected2,062 at risk
RENAL ARTERY STENOSIS	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected2,064 at risk EG0014 affected2,062 at risk
RENAL FAILURE CHRONIC	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected2,064 at risk EG0012 affected2,062 at risk
URINARY BLADDER POLYP	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
ACUTE PRERENAL FAILURE	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
RENAL TUBULAR NECROSIS	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
RENAL ARTERY THROMBOSIS	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
BLADDER NECK OBSTRUCTION	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
URINARY TRACT OBSTRUCTION	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
GLOMERULONEPHRITIS CHRONIC	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
HOSPITALISATION	Surgical and medical procedures	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0011 affected2,062 at risk
CORONARY ARTERY BYPASS	Surgical and medical procedures	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
ARTERIOVENOUS SHUNT OPERATION	Surgical and medical procedures	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
CARDIAC PACEMAKER REPLACEMENT	Surgical and medical procedures	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
GOUT	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0015 affected2,062 at risk
OBESITY	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0012 affected2,062 at risk
ANOREXIA	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected2,064 at risk EG0010 affected2,062 at risk
CACHEXIA	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0010 affected2,062 at risk
DEHYDRATION	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG00021 affected2,064 at risk EG00118 affected2,062 at risk
HYPOKALAEMIA	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG00110 affected2,062 at risk
HYPOVOLAEMIA	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0011 affected2,062 at risk
MALNUTRITION	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
DIABETIC FOOT	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0006 affected2,064 at risk EG0010 affected2,062 at risk
HYPERKALAEMIA	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG00011 affected2,064 at risk EG0018 affected2,062 at risk
HYPOCALCAEMIA	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
HYPOGLYCAEMIA	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG00016 affected2,064 at risk EG0018 affected2,062 at risk
HYPONATRAEMIA	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected2,064 at risk EG0013 affected2,062 at risk
HYPERCALCAEMIA	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
HYPERGLYCAEMIA	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected2,064 at risk EG0012 affected2,062 at risk
FLUID RETENTION	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
DIABETES MELLITUS	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG00011 affected2,064 at risk EG00119 affected2,062 at risk
FAILURE TO THRIVE	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0012 affected2,062 at risk
FOLATE DEFICIENCY	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
DECREASED APPETITE	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
HYPEROSMOLAR STATE	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
METABOLIC ACIDOSIS	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
METABOLIC DISORDER	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0010 affected2,062 at risk
TYPE 1 DIABETES MELLITUS	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
TYPE 2 DIABETES MELLITUS	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0011 affected2,062 at risk
DIABETES MELLITUS INADEQUATE CONTROL	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected2,064 at risk EG0015 affected2,062 at risk
ANAEMIA	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG00031 affected2,064 at risk EG00127 affected2,062 at risk
LEUKOPENIA	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
NEUTROPENIA	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
COAGULOPATHY	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0011 affected2,062 at risk
LEUKOCYTOSIS	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0010 affected2,062 at risk
LYMPHADENOPATHY	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0010 affected2,062 at risk
MICROCYTIC ANAEMIA	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0011 affected2,062 at risk
HYPOCHROMIC ANAEMIA	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
SPONTANEOUS HAEMATOMA	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
IRON DEFICIENCY ANAEMIA	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0011 affected2,062 at risk
LYMPHADENOPATHY MEDIASTINAL	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
ANAEMIA VITAMIN B12 DEFICIENCY	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
NORMOCHROMIC NORMOCYTIC ANAEMIA	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
RASH	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0011 affected2,062 at risk
ECZEMA	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
DRY SKIN	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
PSORIASIS	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
ANGIOEDEMA	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
INTERTRIGO	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
SKIN ULCER	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected2,064 at risk EG0015 affected2,062 at risk
SKIN LESION	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
DRY GANGRENE	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
HYPERHIDROSIS	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0011 affected2,062 at risk
PARAPSORIASIS	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
SKIN NECROSIS	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0013 affected2,062 at risk
DIABETIC ULCER	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
ERYTHEMA NODOSUM	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
HYPOAESTHESIA FACIAL	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
LIPODYSTROPHY ACQUIRED	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
HAEMORRHAGE SUBCUTANEOUS	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
LEUKOCYTOCLASTIC VASCULITIS	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0011 affected2,062 at risk
COLPOCELE	Reproductive system and breast disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
CYSTOCELE	Reproductive system and breast disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
RECTOCELE	Reproductive system and breast disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0012 affected2,062 at risk
PROSTATISM	Reproductive system and breast disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
BREAST MASS	Reproductive system and breast disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0010 affected2,062 at risk
PROSTATITIS	Reproductive system and breast disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0011 affected2,062 at risk
METRORRHAGIA	Reproductive system and breast disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0013 affected2,062 at risk
OVARIAN CYST	Reproductive system and breast disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
UTERINE POLYP	Reproductive system and breast disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0012 affected2,062 at risk
CERVIX DISORDER	Reproductive system and breast disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
GENITAL PROLAPSE	Reproductive system and breast disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
UTERINE DISORDER	Reproductive system and breast disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
UTERINE PROLAPSE	Reproductive system and breast disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0011 affected2,062 at risk
VAGINAL PROLAPSE	Reproductive system and breast disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0011 affected2,062 at risk
PROSTATIC DISORDER	Reproductive system and breast disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
ERECTILE DYSFUNCTION	Reproductive system and breast disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
ENDOMETRIAL HYPERPLASIA	Reproductive system and breast disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0011 affected2,062 at risk
UTERINE CERVIX STENOSIS	Reproductive system and breast disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
BENIGN PROSTATIC HYPERPLASIA	Reproductive system and breast disorders	MedDRA 11.0	Systematic Assessment	EG0005 affected2,064 at risk EG0014 affected2,062 at risk
HIP DYSPLASIA	Congenital, familial and genetic disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
FALL	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG00022 affected2,064 at risk EG00123 affected2,062 at risk
WOUND	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0011 affected2,062 at risk
INJURY	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
OVERDOSE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0003 affected2,064 at risk EG0011 affected2,062 at risk
CONTUSION	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0003 affected2,064 at risk EG0013 affected2,062 at risk
CONCUSSION	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0005 affected2,064 at risk EG0012 affected2,062 at risk
EYE INJURY	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
ANIMAL BITE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
EXCORIATION	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
HEAD INJURY	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0008 affected2,064 at risk EG0012 affected2,062 at risk
HEAT STROKE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
LIMB INJURY	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
HIP FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG00012 affected2,064 at risk EG0019 affected2,062 at risk
JOINT INJURY	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0010 affected2,062 at risk
RIB FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0003 affected2,064 at risk EG0015 affected2,062 at risk
THERMAL BURN	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0011 affected2,062 at risk
DRUG TOXICITY	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0011 affected2,062 at risk
HAND FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
ULNA FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0010 affected2,062 at risk
ANIMAL SCRATCH	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
ANKLE FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0015 affected2,062 at risk
DEVICE FAILURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0012 affected2,062 at risk
FEMUR FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG00010 affected2,064 at risk EG0017 affected2,062 at risk
GUN SHOT WOUND	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
ILIUM FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
RETINAL INJURY	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
SKULL FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
SUTURE RUPTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
TIBIA FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0011 affected2,062 at risk
WRIST FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0012 affected2,062 at risk
BRAIN CONTUSION	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
EYEBALL RUPTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
FIBULA FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
PELVIC FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0003 affected2,064 at risk EG0013 affected2,062 at risk
RADIUS FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0004 affected2,064 at risk EG0011 affected2,062 at risk
SKELETAL INJURY	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
SKIN LACERATION	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
SPINAL FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0011 affected2,062 at risk
FOREARM FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
FRACTURED SACRUM	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
HUMERUS FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0011 affected2,062 at risk
LIGAMENT RUPTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
PATELLA FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
STERNAL FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
WOUND DEHISCENCE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
ALCOHOL POISONING	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0011 affected2,062 at risk
CLAVICLE FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0011 affected2,062 at risk
JOINT DISLOCATION	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0003 affected2,064 at risk EG0012 affected2,062 at risk
MULTIPLE INJURIES	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0011 affected2,062 at risk
BURNS THIRD DEGREE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
DEVICE DISLOCATION	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
SUBDURAL HAEMATOMA	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0003 affected2,064 at risk EG0012 affected2,062 at risk
TRAUMATIC FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
LOWER LIMB FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0004 affected2,064 at risk EG0011 affected2,062 at risk
PUBIC RAMI FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0012 affected2,062 at risk
UPPER LIMB FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0004 affected2,064 at risk EG0012 affected2,062 at risk
COMPRESSION FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0011 affected2,062 at risk
EXTRADURAL HAEMATOMA	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
HAEMATURIA TRAUMATIC	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
POSTOPERATIVE HERNIA	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
SUBDURAL HAEMORRHAGE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0010 affected2,062 at risk
ANAEMIA POSTOPERATIVE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
CARDIAC VALVE RUPTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
CHEMICAL BURN OF SKIN	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
FACIAL BONES FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
FEMORAL NECK FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0012 affected2,062 at risk
ROAD TRAFFIC ACCIDENT	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0013 affected2,062 at risk
SUBCUTANEOUS HAEMATOMA	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
EXPOSURE TO TOXIC AGENT	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
TRACHEOSTOMY MALFUNCTION	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
VASCULAR GRAFT OCCLUSION	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
DEVICE ELECTRICAL FINDING	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0013 affected2,062 at risk
POST PROCEDURAL HAEMATURIA	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
THERAPEUTIC AGENT TOXICITY	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0012 affected2,062 at risk
CERVICAL VERTEBRAL FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
MEDICAL DEVICE COMPLICATION	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0011 affected2,062 at risk
SPINAL COMPRESSION FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0012 affected2,062 at risk
THORACIC VERTEBRAL FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
VASCULAR GRAFT COMPLICATION	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
CARDIAC PACEMAKER MALFUNCTION	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG00011 affected2,064 at risk EG0013 affected2,062 at risk
ARTERIOVENOUS GRAFT THROMBOSIS	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0012 affected2,062 at risk
DISLOCATION OF JOINT PROSTHESIS	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
MYALGIA	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0012 affected2,062 at risk
BURSITIS	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected2,064 at risk EG0011 affected2,062 at risk
MYOPATHY	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
OSTEITIS	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0010 affected2,062 at risk
ARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0008 affected2,064 at risk EG0013 affected2,062 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG00013 affected2,064 at risk EG00111 affected2,062 at risk
BONE PAIN	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0014 affected2,062 at risk
EXOSTOSIS	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected2,064 at risk EG0011 affected2,062 at risk
NECK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
SCOLIOSIS	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0008 affected2,064 at risk EG0017 affected2,062 at risk
GROIN PAIN	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
OSTEOLYSIS	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
PAIN IN JAW	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
SPONDYLITIS	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
GOUTY TOPHUS	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
OSTEOPOROSIS	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected2,064 at risk EG0011 affected2,062 at risk
SACROILIITIS	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
HAEMARTHROSIS	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
METATARSALGIA	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
OSTEONECROSIS	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
FOOT DEFORMITY	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0013 affected2,062 at risk
JOINT EFFUSION	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
OSTEOARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG00037 affected2,064 at risk EG00124 affected2,062 at risk
COSTOCHONDRITIS	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
GOUTY ARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
MUSCLE DISORDER	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
OSTEOCHONDROSIS	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0005 affected2,064 at risk EG0012 affected2,062 at risk
FLOATING PATELLA	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
ACQUIRED CLAW TOE	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
MUSCULAR WEAKNESS	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0015 affected2,062 at risk
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected2,064 at risk EG0016 affected2,062 at risk
SPONDYLOLISTHESIS	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
MUSCLE HAEMORRHAGE	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
COMPARTMENT SYNDROME	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
LOWER LIMB DEFORMITY	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
MUSCULOSKELETAL PAIN	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0012 affected2,062 at risk
RHEUMATOID ARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected2,064 at risk EG0011 affected2,062 at risk
PATHOLOGICAL FRACTURE	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0011 affected2,062 at risk
ROTATOR CUFF SYNDROME	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0012 affected2,062 at risk
SPINAL OSTEOARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0011 affected2,062 at risk
LUMBAR SPINAL STENOSIS	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0012 affected2,062 at risk
POLYMYALGIA RHEUMATICA	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0011 affected2,062 at risk
SPINAL COLUMN STENOSIS	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0014 affected2,062 at risk
NEUROPATHIC ARTHROPATHY	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
MUSCULOSKELETAL STIFFNESS	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
MUSCULOSKELETAL CHEST PAIN	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0013 affected2,062 at risk
INTERVERTEBRAL DISC DISORDER	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
SYSTEMIC LUPUS ERYTHEMATOSUS	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
INTERVERTEBRAL DISC PROTRUSION	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected2,064 at risk EG0016 affected2,062 at risk
COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0012 affected2,062 at risk
APNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
ASTHMA	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected2,064 at risk EG0014 affected2,062 at risk
HYPOXIA	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0013 affected2,062 at risk
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG00065 affected2,064 at risk EG00172 affected2,062 at risk
PLEURISY	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
EMPHYSEMA	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
EPISTAXIS	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected2,064 at risk EG0014 affected2,062 at risk
ASPIRATION	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0010 affected2,062 at risk
ORTHOPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
ATELECTASIS	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
HAEMOPTYSIS	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0005 affected2,064 at risk EG0010 affected2,062 at risk
HAEMOTHORAX	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0011 affected2,062 at risk
HYDROTHORAX	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0010 affected2,062 at risk
HYPERCAPNIA	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0011 affected2,062 at risk
PNEUMONITIS	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
BRONCHOSPASM	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0011 affected2,062 at risk
PNEUMOTHORAX	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0012 affected2,062 at risk
LUNG DISORDER	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected2,064 at risk EG0013 affected2,062 at risk
HYPOVENTILATION	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0011 affected2,062 at risk
ASTHMATIC CRISIS	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
DYSPNOEA AT REST	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected2,064 at risk EG0010 affected2,062 at risk
PLEURAL EFFUSION	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0008 affected2,064 at risk EG0015 affected2,062 at risk
PULMONARY OEDEMA	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG00015 affected2,064 at risk EG00125 affected2,062 at risk
LUNG INFILTRATION	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0010 affected2,062 at risk
BRONCHITIS CHRONIC	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected2,064 at risk EG0012 affected2,062 at risk
BRONCHOPNEUMOPATHY	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
NOCTURNAL DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
PULMONARY EMBOLISM	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG00020 affected2,064 at risk EG00127 affected2,062 at risk
PULMONARY FIBROSIS	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0012 affected2,062 at risk
RESPIRATORY ARREST	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0012 affected2,062 at risk
DYSPNOEA EXERTIONAL	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0005 affected2,064 at risk EG0012 affected2,062 at risk
PLEURAL HAEMORRHAGE	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0009 affected2,064 at risk EG00115 affected2,062 at risk
PNEUMONIA ASPIRATION	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0012 affected2,062 at risk
PULMONARY CONGESTION	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
PULMONARY HILUM MASS	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
RESPIRATORY ACIDOSIS	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
RESPIRATORY DISORDER	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
RESPIRATORY DISTRESS	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0012 affected2,062 at risk
BRONCHIAL OBSTRUCTION	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
PULMONARY AMYLOIDOSIS	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
PULMONARY HAEMORRHAGE	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0010 affected2,062 at risk
SLEEP APNOEA SYNDROME	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0011 affected2,062 at risk
ACUTE PULMONARY OEDEMA	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0009 affected2,064 at risk EG00112 affected2,062 at risk
NASAL SEPTUM DEVIATION	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
PULMONARY HYPERTENSION	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0015 affected2,062 at risk
ACUTE RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0012 affected2,062 at risk
CHEYNE-STOKES RESPIRATION	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
INTERSTITIAL LUNG DISEASE	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0011 affected2,062 at risk
PULMONARY ARTERY THROMBOSIS	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
OBSTRUCTIVE AIRWAYS DISORDER	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected2,064 at risk EG0010 affected2,062 at risk
PULMONARY ARTERIAL HYPERTENSION	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
ACUTE RESPIRATORY DISTRESS SYNDROME	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0011 affected2,062 at risk
CHRONIC OBSTRUCTIVE PULMONARY DISEASE	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG00021 affected2,064 at risk EG00123 affected2,062 at risk
PAIN	General disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
DEATH	General disorders	MedDRA 11.0	Systematic Assessment	EG0005 affected2,064 at risk EG0019 affected2,062 at risk
POLYP	General disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
CHILLS	General disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0012 affected2,062 at risk
HERNIA	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0012 affected2,062 at risk
NODULE	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
OEDEMA	General disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0011 affected2,062 at risk
FATIGUE	General disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected2,064 at risk EG0013 affected2,062 at risk
MALAISE	General disorders	MedDRA 11.0	Systematic Assessment	EG0008 affected2,064 at risk EG0015 affected2,062 at risk
PYREXIA	General disorders	MedDRA 11.0	Systematic Assessment	EG0006 affected2,064 at risk EG0018 affected2,062 at risk
ASTHENIA	General disorders	MedDRA 11.0	Systematic Assessment	EG0008 affected2,064 at risk EG0017 affected2,062 at risk
EFFUSION	General disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
NECROSIS	General disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0015 affected2,062 at risk
DYSPLASIA	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
ENANTHEMA	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
CHEST PAIN	General disorders	MedDRA 11.0	Systematic Assessment	EG00075 affected2,064 at risk EG00181 affected2,062 at risk
SUDDEN DEATH	General disorders	MedDRA 11.0	Systematic Assessment	EG00070 affected2,064 at risk EG00176 affected2,062 at risk
ADVERSE EVENT	General disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
CARDIAC DEATH	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
ACCIDENTAL DEATH	General disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
CHEST DISCOMFORT	General disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected2,064 at risk EG0015 affected2,062 at risk
GAIT DISTURBANCE	General disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
IMPAIRED HEALING	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0011 affected2,062 at risk
LOCALISED OEDEMA	General disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
PERFORATED ULCER	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
OEDEMA PERIPHERAL	General disorders	MedDRA 11.0	Systematic Assessment	EG0008 affected2,064 at risk EG00111 affected2,062 at risk
ULCER HAEMORRHAGE	General disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
GENERALISED OEDEMA	General disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
MULTI-ORGAN FAILURE	General disorders	MedDRA 11.0	Systematic Assessment	EG0005 affected2,064 at risk EG0012 affected2,062 at risk
PERIPHERAL COLDNESS	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
SUDDEN CARDIAC DEATH	General disorders	MedDRA 11.0	Systematic Assessment	EG0006 affected2,064 at risk EG00111 affected2,062 at risk
ADVERSE DRUG REACTION	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
IMPLANT SITE HAEMATOMA	General disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
NON-CARDIAC CHEST PAIN	General disorders	MedDRA 11.0	Systematic Assessment	EG0006 affected2,064 at risk EG0015 affected2,062 at risk
TEMPERATURE INTOLERANCE	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
CATHETER RELATED COMPLICATION	General disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
DRUG CHEMICAL INCOMPATIBILITY	General disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
MECHANICAL COMPLICATION OF IMPLANT	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0011 affected2,062 at risk
GENERAL PHYSICAL HEALTH DETERIORATION	General disorders	MedDRA 11.0	Systematic Assessment	EG0008 affected2,064 at risk EG0017 affected2,062 at risk
LIPOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0012 affected2,062 at risk
LYMPHOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
MENINGIOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0003 affected2,064 at risk EG0011 affected2,062 at risk
METASTASIS	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0012 affected2,062 at risk
SKIN CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0013 affected2,062 at risk
COLON CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG00010 affected2,064 at risk EG0015 affected2,062 at risk
LIP NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
RENAL CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0012 affected2,062 at risk
BONE NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
BREAST CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG00010 affected2,064 at risk EG00110 affected2,062 at risk
COLON ADENOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0010 affected2,062 at risk
LUNG NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0011 affected2,062 at risk
NEOPLASM SKIN	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
RECTAL CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0012 affected2,062 at risk
TONSIL CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
ADENOCARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0014 affected2,062 at risk
ADENOMA BENIGN	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
BLADDER CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0004 affected2,064 at risk EG0014 affected2,062 at risk
BRAIN NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0011 affected2,062 at risk
COLON NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
GASTRIC CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0006 affected2,064 at risk EG0015 affected2,062 at risk
OVARIAN CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0014 affected2,062 at risk
THYROID CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0012 affected2,062 at risk
UTERINE CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
BREAST NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
PROSTATE CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG00012 affected2,064 at risk EG0017 affected2,062 at risk
RECTAL NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
THYROID ADENOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
TRACHEAL CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
URETHRAL CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
ADRENAL NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
BILE DUCT CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0011 affected2,062 at risk
BLADDER NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0012 affected2,062 at risk
CARCINOID TUMOUR	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
CERVIX CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
LARYNGEAL CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
MULTIPLE MYELOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0011 affected2,062 at risk
OVARIAN NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0003 affected2,064 at risk EG0010 affected2,062 at risk
PLEURAL NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
THYROID NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
BLADDER PAPILLOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
NEOPLASM PROSTATE	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
PROSTATIC ADENOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0013 affected2,062 at risk
UTERINE LEIOMYOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0011 affected2,062 at risk
ABDOMINAL NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
ENDOMETRIAL CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0011 affected2,062 at risk
GALLBLADDER CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0011 affected2,062 at risk
MALIGNANT MELANOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0011 affected2,062 at risk
METASTASES TO BONE	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0011 affected2,062 at risk
NEOPLASM MALIGNANT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0008 affected2,064 at risk EG0013 affected2,062 at risk
BRONCHIAL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
LUNG ADENOCARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0012 affected2,062 at risk
METASTASES TO LIVER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0011 affected2,062 at risk
METASTASES TO SPINE	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0012 affected2,062 at risk
METASTATIC NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0011 affected2,062 at risk
PANCREATIC NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
BASAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0009 affected2,064 at risk EG00112 affected2,062 at risk
COLON CANCER STAGE 0	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
METASTASES TO PLEURA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
PANCREATIC CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0014 affected2,062 at risk
RENAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
OESOPHAGEAL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0011 affected2,062 at risk
RECTAL CANCER STAGE 0	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
SALIVARY GLAND CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0011 affected2,062 at risk
BENIGN BREAST NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
COLON CANCER RECURRENT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
LUNG CANCER METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0012 affected2,062 at risk
NON-HODGKIN'S LYMPHOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
COLON CANCER METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0011 affected2,062 at risk
LUNG NEOPLASM MALIGNANT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0007 affected2,064 at risk EG0018 affected2,062 at risk
SALIVARY GLAND NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
SQUAMOUS CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0012 affected2,062 at risk
BREAST CANCER METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
CERVIX CARCINOMA STAGE 0	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
METASTASES TO PERITONEUM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
PROSTATE CANCER STAGE IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
RETROPERITONEAL NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
HEPATIC CANCER METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
MALIGNANT MUSCLE NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
METASTATIC GASTRIC CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0012 affected2,062 at risk
HEPATIC NEOPLASM MALIGNANT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0012 affected2,062 at risk
MALIGNANT PLEURAL EFFUSION	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
PROSTATE CANCER METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
BENIGN MEDIASTINAL NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
MYELOPROLIFERATIVE DISORDER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
CHRONIC LYMPHOCYTIC LEUKAEMIA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0011 affected2,062 at risk
MALIGNANT FIBROUS HISTIOCYTOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
SQUAMOUS CELL CARCINOMA OF SKIN	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0010 affected2,062 at risk
MALIGNANT URINARY TRACT NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
WALDENSTROM'S MACROGLOBULINAEMIA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
LENTIGO MALIGNA STAGE UNSPECIFIED	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
METASTATIC SQUAMOUS CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
CHRONIC LYMPHOCYTIC LEUKAEMIA STAGE 0	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected2,064 at risk EG0010 affected2,062 at risk
CHRONIC MYELOID LEUKAEMIA TRANSFORMATION	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected2,064 at risk EG0011 affected2,062 at risk
LUNG SQUAMOUS CELL CARCINOMA STAGE UNSPECIFIED	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0002 affected2,064 at risk EG0012 affected2,062 at risk

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	IRBESARTAN	titration from 75 to 300 mg, once daily (QD), up to 6 years			1,146	2,064	1,255	2,064
EG001	PLACEBO	titration from 75 to 300 mg, once daily (QD), up to 6 years			1,155	2,062	1,191	2,062

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

ID	Term
D001713	Biphenyl Compounds
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D013141	Spiro Compounds
D013777	Tetrazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D011083	Polycyclic Compounds

ID	Title	Description
BG000	Irbesartan	titration from 75 to 300 mg, once daily (QD), up to 6 years
BG001	Placebo	titration from 75 to 300 mg, once daily (QD), up to 6 years
BG002	Total	Total of all reporting groups