Prospective ARNI vs ACE Inhibitor Trial to DetermIne Supe... | NCT02924727

ID	Type	Description	Link
2016-002154-20	EudraCT Number

Label	Type	Description	Intervention Names
LCZ696 (sacubitril/valsartan)	Experimental	Following randomization, patients will receive LCZ696 in titrated doses from level 1 up to level 3 (50, 100 and 200 mg twice daily). Patients will be required to take a total of two pills, (one tablet from the LCZ696 pack and one capsule from ramipril matching placebo pack) twice a day for the duration of the study. Patients randomized to LCZ who were previously treated with ACE inhibitors receiving the last dose of that agent during the last 36 hours prior to randomization will receive a valsartan bridge for one day. These patients will receive two doses of valsartan for 1 day in a blinded manner prior to beginning double-blind LCZ696 treatment.	Drug: LCZ696 (sacubitril/valsartan) Drug: Placebo of ramipril Drug: Valsartan
Ramipril	Active Comparator	Following randomization, patients will receive the Ramipril in titrated doses from level 1 up to level 3 (1.25, 2.5 and 5 mg twice daily). Patients will be required to take a total of two pills, (one capsule from the ramipril pack and one tablet from LCZ696 matching placebo pack) twice a day for the duration of the study. Patients randomized to ramipril who were previously treated with ACE inhibitors receiving the last dose of that agent during the last 36 hours prior to randomization will immediately start on double-blind ramipril; however, to maintain double blind/double dummy of the valsartan bridge, these patients will receive two doses of matching valsartan placebo for 1 day in a blinded manner prior to beginning double-blind LCZ696 placebo.	Drug: Ramipril Drug: Placebo of LCZ696 Drug: Placebo of valsartan

Name	Type	Description	Arm Group Labels	Other Names
LCZ696 (sacubitril/valsartan)	Drug	LCZ696 (sacubitril/valsartan) tablet will be available in 24/26 mg, 49/51 mg and 97/103 mg, respectively	LCZ696 (sacubitril/valsartan)

Measure	Description	Time Frame
Number of Participants With First CEC (Clinical Endpoint Committee) Confirmed Primary Composite Endpoint	A confirmed composite endpoint includes cardiovascular (CV) death, heart failure (HF) hospitalization, or outpatient heart failure	From randomization to first occurrence (up to approximately 43 months)

Measure	Description	Time Frame
Number of Participants With a Confirmed Composite of CV Death or HF Hospitalization	A confirmed composite endpoint for this outcome measure includes cardiovascular death or heart failure hospitalization.	Time from randomization to first occurrence (up to approximately 43 months)
Number of Participants With a Confirmed Composite of HF Hospitalization or Outpatient HF

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Birmingham	Alabama	35243	United States
Novartis Investigative Site

PubMed Identifier	Type	Citation	Retractions
39110471	Derived	Curtain JP, Pfeffer MA, Braunwald E, Claggett BL, Granger CB, Kober L, Lewis EF, Maggioni AP, Mann DL, Rouleau JL, Solomon SD, Steg PG, Finn PV, Fernandez A, Jering KS, McMurray JJV. Rates of Sudden Death After Myocardial Infarction-Insights From the VALIANT and PARADISE-MI Trials. JAMA Cardiol. 2024 Oct 1;9(10):928-933. doi: 10.1001/jamacardio.2024.2356.
38418004

ID	Title	Description
FG000	LCZ696 (Sacubitril/Valsartan)	Following randomization, patients received LCZ696 in titrated doses from level 1 up to level 3 (50, 100 and 200 mg twice daily). Patients were required to take a total of two pills, (one tablet from the LCZ696 pack and one capsule from Ramipril matching placebo pack) twice a day for the duration of the study. Patients randomized to LCZ who were previously treated with ACE inhibitors, receiving the last dose of that agent during the last 36 hours prior to randomization, received a valsartan bridge for one day. These patients received two doses of valsartan for 1 day in a blinded manner prior to beginning double-blind LCZ696 treatment.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	May 18, 2016	Jan 20, 2022

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG00230 affected2,820 at risk EG00323 affected2,816 at risk
Anaemia macrocytic	Blood and lymphatic system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Anaemia vitamin B12 deficiency	Blood and lymphatic system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Blood loss anaemia	Blood and lymphatic system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0023 affected2,820 at risk EG003
Eosinophilia	Blood and lymphatic system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Hypochromic anaemia	Blood and lymphatic system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0022 affected2,820 at risk EG003
Hypocoagulable state	Blood and lymphatic system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Immune thrombocytopenia	Blood and lymphatic system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0027 affected2,820 at risk EG003
Leukocytosis	Blood and lymphatic system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Microcytic anaemia	Blood and lymphatic system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Normocytic anaemia	Blood and lymphatic system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Pancytopenia	Blood and lymphatic system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Splenic haemorrhage	Blood and lymphatic system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Acute coronary syndrome	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG00211 affected2,820 at risk EG003
Acute left ventricular failure	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0029 affected2,820 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG00292 affected2,820 at risk EG003
Adams-Stokes syndrome	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG00259 affected2,820 at risk EG003
Angina unstable	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG00265 affected2,820 at risk EG003
Anginal equivalent	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Aortic valve disease	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Aortic valve incompetence	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Aortic valve stenosis	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Arrhythmia	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0029 affected2,820 at risk EG003
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0022 affected2,820 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG00230 affected2,820 at risk EG003
Atrial flutter	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0026 affected2,820 at risk EG003
Atrial tachycardia	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Atrioventricular block	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0025 affected2,820 at risk EG003
Atrioventricular block complete	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0022 affected2,820 at risk EG003
Atrioventricular block second degree	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0022 affected2,820 at risk EG003
Bradycardia	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0026 affected2,820 at risk EG003
Cardiac aneurysm	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG00224 affected2,820 at risk EG003
Cardiac asthma	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0022 affected2,820 at risk EG003
Cardiac discomfort	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Cardiac disorder	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0022 affected2,820 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG002149 affected2,820 at risk EG003
Cardiac failure acute	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG00228 affected2,820 at risk EG003
Cardiac failure chronic	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG00212 affected2,820 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG00227 affected2,820 at risk EG003
Cardiac perforation	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Cardiac tamponade	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Cardiac ventricular thrombosis	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0024 affected2,820 at risk EG003
Cardio-respiratory arrest	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0027 affected2,820 at risk EG003
Cardiogenic shock	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG00217 affected2,820 at risk EG003
Cardiomyopathy	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Cardiopulmonary failure	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Cardiovascular disorder	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Cardiovascular insufficiency	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Chronic left ventricular failure	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Congestive cardiomyopathy	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG00223 affected2,820 at risk EG003
Coronary artery insufficiency	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Coronary artery occlusion	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0023 affected2,820 at risk EG003
Coronary artery perforation	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Coronary artery stenosis	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Dressler's syndrome	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Endocarditis noninfective	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Intracardiac thrombus	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0026 affected2,820 at risk EG003
Left ventricular dysfunction	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0023 affected2,820 at risk EG003
Left ventricular failure	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Microvascular coronary artery disease	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Mitral valve incompetence	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0025 affected2,820 at risk EG003
Myocardial fibrosis	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0022 affected2,820 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG00251 affected2,820 at risk EG003
Myocardial ischaemia	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0029 affected2,820 at risk EG003
Palpitations	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0024 affected2,820 at risk EG003
Papillary muscle disorder	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Paroxysmal atrioventricular block	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Pericardial effusion	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0022 affected2,820 at risk EG003
Pericardial haemorrhage	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Pericarditis	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0026 affected2,820 at risk EG003
Pulseless electrical activity	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Sinus bradycardia	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Sinus node dysfunction	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0023 affected2,820 at risk EG003
Supraventricular tachycardia	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0022 affected2,820 at risk EG003
Tachycardia	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0023 affected2,820 at risk EG003
Ventricle rupture	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Ventricular arrhythmia	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0022 affected2,820 at risk EG003
Ventricular dysfunction	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Ventricular extrasystoles	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0022 affected2,820 at risk EG003
Ventricular fibrillation	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG00212 affected2,820 at risk EG003
Ventricular remodelling	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Ventricular tachyarrhythmia	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Ventricular tachycardia	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG00219 affected2,820 at risk EG003
Ventricular septal defect	Congenital, familial and genetic disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0024 affected2,820 at risk EG003
Vertigo positional	Ear and labyrinth disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Vestibular disorder	Ear and labyrinth disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Adrenal mass	Endocrine disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Hyperthyroidism	Endocrine disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Arteriosclerotic retinopathy	Eye disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Blindness unilateral	Eye disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Cataract	Eye disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0023 affected2,820 at risk EG003
Diplopia	Eye disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0022 affected2,820 at risk EG003
Eye oedema	Eye disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Eye swelling	Eye disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Glaucoma	Eye disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Intraocular haematoma	Eye disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Iridocyclitis	Eye disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Keratitis	Eye disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Open angle glaucoma	Eye disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Optic ischaemic neuropathy	Eye disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Periorbital oedema	Eye disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Retinal detachment	Eye disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Rhegmatogenous retinal detachment	Eye disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Visual impairment	Eye disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0022 affected2,820 at risk EG003
Vitreous haemorrhage	Eye disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0022 affected2,820 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Abdominal hernia	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Abdominal hernia obstructive	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Abdominal mass	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0028 affected2,820 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0027 affected2,820 at risk EG003
Acute abdomen	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0022 affected2,820 at risk EG003
Colitis ischaemic	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0022 affected2,820 at risk EG003
Crohn's disease	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Dental cyst	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0024 affected2,820 at risk EG003
Diarrhoea haemorrhagic	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Diverticular perforation	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Diverticulum intestinal	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Diverticulum intestinal haemorrhagic	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Duodenal ulcer	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0022 affected2,820 at risk EG003
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0023 affected2,820 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0023 affected2,820 at risk EG003
Enteritis	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Enterocolitis	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Faeces discoloured	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Food poisoning	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Gastric haemorrhage	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Gastric ulcer	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0022 affected2,820 at risk EG003
Gastritis erosive	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Gastritis haemorrhagic	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG00215 affected2,820 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0024 affected2,820 at risk EG003
Haematemesis	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Haematochezia	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0022 affected2,820 at risk EG003
Haemorrhoids thrombosed	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Ileus	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0022 affected2,820 at risk EG003
Ileus paralytic	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Impaired gastric emptying	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0025 affected2,820 at risk EG003
Intestinal haemorrhage	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Intestinal ischaemia	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Intestinal pseudo-obstruction	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Large intestinal obstruction	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Large intestine perforation	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Large intestine polyp	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Lip swelling	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Malabsorption	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Mechanical ileus	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Melaena	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0027 affected2,820 at risk EG003
Mesenteric arterial occlusion	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Mouth swelling	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0025 affected2,820 at risk EG003
Oesophageal achalasia	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0022 affected2,820 at risk EG003
Peptic ulcer	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0022 affected2,820 at risk EG003
Peritoneal adhesions	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0023 affected2,820 at risk EG003
Rectal polyp	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Retroperitoneal haemorrhage	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Umbilical hernia	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0022 affected2,820 at risk EG003
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0023 affected2,820 at risk EG003
Volvulus	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0025 affected2,820 at risk EG003
Adverse event	General disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Asthenia	General disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0023 affected2,820 at risk EG003
Cardiac death	General disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0025 affected2,820 at risk EG003
Chest discomfort	General disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0023 affected2,820 at risk EG003
Chest pain	General disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Complication associated with device	General disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Death	General disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG00227 affected2,820 at risk EG003
Disease progression	General disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Drowning	General disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Exercise tolerance decreased	General disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Fatigue	General disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
General physical health deterioration	General disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Generalised oedema	General disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Hypothermia	General disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Impaired healing	General disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Malaise	General disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Multiple organ dysfunction syndrome	General disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0023 affected2,820 at risk EG003
Necrosis	General disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG00254 affected2,820 at risk EG003
Oedema peripheral	General disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Polyp	General disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Pyrexia	General disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0027 affected2,820 at risk EG003
Sudden cardiac death	General disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG00210 affected2,820 at risk EG003
Sudden death	General disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0029 affected2,820 at risk EG003
Surgical failure	General disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Ulcer haemorrhage	General disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Unevaluable event	General disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Vascular stent stenosis	General disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0025 affected2,820 at risk EG003
Vascular stent thrombosis	General disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0027 affected2,820 at risk EG003
Acute hepatic failure	Hepatobiliary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Autoimmune hepatitis	Hepatobiliary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Bile duct stenosis	Hepatobiliary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Bile duct stone	Hepatobiliary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Biliary colic	Hepatobiliary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Biliary cyst	Hepatobiliary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Biliary dilatation	Hepatobiliary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Biliary dyspepsia	Hepatobiliary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Cholangitis acute	Hepatobiliary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0024 affected2,820 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0029 affected2,820 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0024 affected2,820 at risk EG003
Drug-induced liver injury	Hepatobiliary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Hepatic failure	Hepatobiliary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Hepatic mass	Hepatobiliary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Hepatic pain	Hepatobiliary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Hepatitis	Hepatobiliary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Hepatitis acute	Hepatobiliary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Ischaemic hepatitis	Hepatobiliary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0022 affected2,820 at risk EG003
Jaundice cholestatic	Hepatobiliary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Anaphylactic shock	Immune system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Contrast media allergy	Immune system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Drug hypersensitivity	Immune system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Abscess	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0022 affected2,820 at risk EG003
Abscess jaw	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Abscess limb	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0023 affected2,820 at risk EG003
Abscess oral	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Anal abscess	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0022 affected2,820 at risk EG003
Appendicitis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0023 affected2,820 at risk EG003
Bacteraemia	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0023 affected2,820 at risk EG003
Bacterial abdominal infection	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Bacterial infection	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Bacterial sepsis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Biliary sepsis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Bone abscess	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Bronchitis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0023 affected2,820 at risk EG003
COVID-19	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG00213 affected2,820 at risk EG003
COVID-19 pneumonia	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0026 affected2,820 at risk EG003
Carbuncle	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Cellulitis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG00211 affected2,820 at risk EG003
Cholangitis infective	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Clostridium difficile infection	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Coronavirus infection	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0024 affected2,820 at risk EG003
Cystitis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0027 affected2,820 at risk EG003
Device related infection	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Diabetic foot infection	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Diabetic gangrene	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Diarrhoea infectious	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Diverticulitis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0023 affected2,820 at risk EG003
Empyema	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Endocarditis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0023 affected2,820 at risk EG003
Endocarditis staphylococcal	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Endometritis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Epididymitis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Erysipelas	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0026 affected2,820 at risk EG003
Escherichia bacteraemia	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0022 affected2,820 at risk EG003
Escherichia sepsis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Escherichia urinary tract infection	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Fournier's gangrene	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Gangrene	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0023 affected2,820 at risk EG003
Gas gangrene	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG00211 affected2,820 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Gastrointestinal infection	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Genital herpes	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Haematoma infection	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Helicobacter duodenal ulcer	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Implant site infection	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Incision site abscess	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Infected dermal cyst	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Infected skin ulcer	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Infection	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0024 affected2,820 at risk EG003
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Influenza	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0023 affected2,820 at risk EG003
Joint abscess	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Labyrinthitis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Liver abscess	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Localised infection	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0022 affected2,820 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0024 affected2,820 at risk EG003
Lung abscess	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Meningitis bacterial	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Necrotising fasciitis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Neutropenic sepsis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Oral candidiasis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Orchitis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Osteomyelitis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0024 affected2,820 at risk EG003
Osteomyelitis acute	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Otitis externa	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Otitis media	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Parotitis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Peritonitis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Pharyngeal abscess	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Pharyngotonsillitis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Pneumonia	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG00261 affected2,820 at risk EG003
Pneumonia bacterial	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0023 affected2,820 at risk EG003
Pneumonia mycoplasmal	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Pneumonia pneumococcal	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Pneumonia staphylococcal	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Pneumonia viral	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Post procedural sepsis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Postoperative wound infection	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Pulmonary tuberculosis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0022 affected2,820 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0023 affected2,820 at risk EG003
Pyelonephritis acute	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0023 affected2,820 at risk EG003
Pyelonephritis chronic	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0023 affected2,820 at risk EG003
Respiratory tract infection viral	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Rhinovirus infection	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0022 affected2,820 at risk EG003
Scrotal abscess	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0022 affected2,820 at risk EG003
Sepsis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG00219 affected2,820 at risk EG003
Septic shock	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0029 affected2,820 at risk EG003
Skin infection	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Staphylococcal bacteraemia	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Staphylococcal sepsis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Suspected COVID-19	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0022 affected2,820 at risk EG003
Tooth abscess	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0022 affected2,820 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG00228 affected2,820 at risk EG003
Urosepsis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0026 affected2,820 at risk EG003
Vestibular neuronitis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Viral labyrinthitis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Viral sepsis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Wound abscess	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Wound infection	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Wound infection bacterial	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Accidental exposure to product	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Acetabulum fracture	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Anaemia postoperative	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Anastomotic leak	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Ankle fracture	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0023 affected2,820 at risk EG003
Arterial bypass occlusion	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0022 affected2,820 at risk EG003
Arterial injury	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0023 affected2,820 at risk EG003
Cardiac function disturbance postoperative	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Cardiac procedure complication	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Cardiac valve rupture	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Chest injury	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Concussion	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0024 affected2,820 at risk EG003
Coronary artery restenosis	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Coronary bypass thrombosis	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Coronary vascular graft occlusion	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Electric shock	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0025 affected2,820 at risk EG003
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0022 affected2,820 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0024 affected2,820 at risk EG003
Fibula fracture	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Foot fracture	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Foreign body in gastrointestinal tract	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Fracture	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Fracture displacement	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Hand fracture	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Head injury	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0022 affected2,820 at risk EG003
Humerus fracture	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0022 affected2,820 at risk EG003
Incisional hernia	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Intentional overdose	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Jaw fracture	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Joint dislocation	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Limb injury	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Muscle injury	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Muscle rupture	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Overdose	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Periorbital haemorrhage	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Periprocedural myocardial infarction	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0022 affected2,820 at risk EG003
Pneumothorax traumatic	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Poisoning	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Post intensive care syndrome	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Post procedural complication	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Post procedural discharge	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Post procedural fistula	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Post procedural haematuria	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0024 affected2,820 at risk EG003
Post procedural myocardial infarction	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Post procedural urine leak	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Prevertebral soft tissue swelling of cervical space	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Procedural complication	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Pulmonary contusion	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Radius fracture	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0022 affected2,820 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Road traffic accident	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Skin abrasion	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Skin laceration	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Splenic rupture	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Sternal fracture	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Stomal hernia	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Subcutaneous haematoma	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Subdural haemorrhage	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Thermal burn	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Traumatic intracranial haemorrhage	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0023 affected2,820 at risk EG003
Vasoplegia syndrome	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Wrist fracture	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Angiocardiogram	Investigations	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0022 affected2,820 at risk EG003
Anticoagulation drug level above therapeutic	Investigations	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Biopsy bladder	Investigations	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Biopsy prostate	Investigations	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Blood creatinine increased	Investigations	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Blood glucose fluctuation	Investigations	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Blood glucose increased	Investigations	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0022 affected2,820 at risk EG003
Blood sodium decreased	Investigations	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Cardiac output decreased	Investigations	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Cardiac ventriculogram	Investigations	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Coagulation test abnormal	Investigations	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Ejection fraction	Investigations	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Ejection fraction abnormal	Investigations	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Ejection fraction decreased	Investigations	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0026 affected2,820 at risk EG003
Electrocardiogram QT prolonged	Investigations	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Glycosylated haemoglobin increased	Investigations	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Haemoglobin decreased	Investigations	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0022 affected2,820 at risk EG003
Heart rate decreased	Investigations	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Hepatic enzyme increased	Investigations	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Influenza B virus test positive	Investigations	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
International normalised ratio increased	Investigations	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Liver function test abnormal	Investigations	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Liver function test increased	Investigations	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Neutrophil count decreased	Investigations	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Occult blood positive	Investigations	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Renal function test abnormal	Investigations	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
SARS-CoV-2 test positive	Investigations	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Scan myocardial perfusion abnormal	Investigations	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Stress echocardiogram	Investigations	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Transaminases increased	Investigations	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Troponin increased	Investigations	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Weight decreased	Investigations	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Weight increased	Investigations	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Acidosis hyperchloraemic	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Cachexia	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0029 affected2,820 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0022 affected2,820 at risk EG003
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0023 affected2,820 at risk EG003
Diabetic metabolic decompensation	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0022 affected2,820 at risk EG003
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Euglycaemic diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Fluid overload	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0022 affected2,820 at risk EG003
Food intolerance	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Gout	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0026 affected2,820 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG00215 affected2,820 at risk EG003
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Hypervolaemia	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0027 affected2,820 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0025 affected2,820 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0023 affected2,820 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Hypovolaemia	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Ketoacidosis	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Lactic acidosis	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Malnutrition	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0022 affected2,820 at risk EG003
Obesity	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Pseudohyponatraemia	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0024 affected2,820 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Arthritis reactive	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Back disorder	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0022 affected2,820 at risk EG003
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Chondrocalcinosis	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0022 affected2,820 at risk EG003
Deformity thorax	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Enthesopathy	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Fistula discharge	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Gouty arthritis	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Haemarthrosis	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Intervertebral disc disorder	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0022 affected2,820 at risk EG003
Mobility decreased	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0022 affected2,820 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0025 affected2,820 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Osteitis	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0023 affected2,820 at risk EG003
Osteochondrosis	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Osteoporotic fracture	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Periostosis	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Polyarthritis	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Polymyalgia rheumatica	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Pseudarthrosis	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Adenocarcinoma pancreas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Anaplastic meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
B-cell small lymphocytic lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
B-cell unclassifiable lymphoma low grade	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0024 affected2,820 at risk EG003
Benign duodenal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0024 affected2,820 at risk EG003
Bladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0022 affected2,820 at risk EG003
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0022 affected2,820 at risk EG003
Bowen's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0023 affected2,820 at risk EG003
Breast cancer stage II	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0022 affected2,820 at risk EG003
Cholangiocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Chronic lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Chronic myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Clear cell renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Colon neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0022 affected2,820 at risk EG003
Colorectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Colorectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0023 affected2,820 at risk EG003
Endometrial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Gallbladder adenosquamous carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Gallbladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Gastric neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Gastrointestinal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Gastrointestinal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Glioblastoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Haemangioma of liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Hepatic cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Hepatocellular carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Hypopharyngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Infected neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Keratoacanthoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Laryngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Laryngeal squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Lip squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0022 affected2,820 at risk EG003
Lung squamous cell carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Lymphangiosis carcinomatosa	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Malignant neoplasm of pleura	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Malignant peritoneal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Marginal zone lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Metastases to lymph nodes	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Metastasis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0022 affected2,820 at risk EG003
Metastatic malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Metastatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0022 affected2,820 at risk EG003
Monoclonal gammopathy	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Myeloproliferative neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Myxoid liposarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Neuroendocrine carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Oesophageal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0023 affected2,820 at risk EG003
Oropharyngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0023 affected2,820 at risk EG003
Papillary cystadenoma lymphomatosum	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Pleural mesothelioma malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0025 affected2,820 at risk EG003
Prostate cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0022 affected2,820 at risk EG003
Rectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0023 affected2,820 at risk EG003
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0024 affected2,820 at risk EG003
Rectal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Renal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0022 affected2,820 at risk EG003
Squamous cell carcinoma of the parotid gland	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Testicular neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Transitional cell cancer of the renal pelvis and ureter	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Vulval cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Arachnoid cyst	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Ataxia	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Brain stem ischaemia	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Carotid artery occlusion	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Carotid artery stenosis	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0025 affected2,820 at risk EG003
Cerebellar infarction	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Cerebral haemorrhage	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Cerebral hypoperfusion	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Cerebral infarction	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0028 affected2,820 at risk EG003
Cerebral ischaemia	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0022 affected2,820 at risk EG003
Cerebral venous sinus thrombosis	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG00232 affected2,820 at risk EG003
Cerebrovascular disorder	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Cerebrovascular insufficiency	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Cervical radiculopathy	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Cervicobrachial syndrome	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Demyelinating polyneuropathy	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Disturbance in attention	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Dizziness	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0027 affected2,820 at risk EG003
Dizziness postural	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Dysarthria	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Embolic stroke	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Encephalopathy	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Epilepsy	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Facial paralysis	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Generalised tonic-clonic seizure	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Haemorrhage intracranial	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Haemorrhagic stroke	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0022 affected2,820 at risk EG003
Haemorrhagic transformation stroke	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Headache	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0022 affected2,820 at risk EG003
Hemianopia	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Hemiparesis	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0022 affected2,820 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Hypoglycaemic coma	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Hypoxic-ischaemic encephalopathy	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0022 affected2,820 at risk EG003
Irregular sleep wake rhythm disorder	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Ischaemic stroke	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG00212 affected2,820 at risk EG003
Lacunar infarction	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Lacunar stroke	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Loss of consciousness	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Metabolic encephalopathy	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0022 affected2,820 at risk EG003
Migraine	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Moyamoya disease	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Partial seizures	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Polyneuropathy	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Post stroke seizure	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Presyncope	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0029 affected2,820 at risk EG003
Psychogenic seizure	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Radiculopathy	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Sciatica	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Seizure	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0022 affected2,820 at risk EG003
Spinal cord haemorrhage	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Status epilepticus	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Subarachnoid haemorrhage	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Subdural hygroma	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Syncope	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG00236 affected2,820 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0029 affected2,820 at risk EG003
Vertebrobasilar insufficiency	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Hyperemesis gravidarum	Pregnancy, puerperium and perinatal conditions	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Pre-eclampsia	Pregnancy, puerperium and perinatal conditions	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Device breakage	Product Issues	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Device defective	Product Issues	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Device dislocation	Product Issues	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Device failure	Product Issues	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Device fastener issue	Product Issues	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Device malfunction	Product Issues	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Device occlusion	Product Issues	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Lead dislodgement	Product Issues	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Anxiety	Psychiatric disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0022 affected2,820 at risk EG003
Completed suicide	Psychiatric disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Confusional state	Psychiatric disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Delirium	Psychiatric disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Delusion	Psychiatric disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Depression	Psychiatric disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Depression suicidal	Psychiatric disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Disorientation	Psychiatric disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Hallucination	Psychiatric disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Intentional self-injury	Psychiatric disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Major depression	Psychiatric disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Mental status changes	Psychiatric disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0022 affected2,820 at risk EG003
Personality change due to a general medical condition	Psychiatric disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Psychiatric decompensation	Psychiatric disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Restlessness	Psychiatric disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Suicidal ideation	Psychiatric disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0022 affected2,820 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG00237 affected2,820 at risk EG003
Anuria	Renal and urinary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Azotaemia	Renal and urinary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Bladder tamponade	Renal and urinary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Calculus bladder	Renal and urinary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Chronic kidney disease	Renal and urinary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0025 affected2,820 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
End stage renal disease	Renal and urinary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0029 affected2,820 at risk EG003
Haemorrhage urinary tract	Renal and urinary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Hydronephrosis	Renal and urinary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0023 affected2,820 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Nephrotic syndrome	Renal and urinary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Renal colic	Renal and urinary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG00210 affected2,820 at risk EG003
Renal haematoma	Renal and urinary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Renal impairment	Renal and urinary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG00214 affected2,820 at risk EG003
Ureteric obstruction	Renal and urinary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Ureteric stenosis	Renal and urinary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Ureterolithiasis	Renal and urinary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0022 affected2,820 at risk EG003
Urethral obstruction	Renal and urinary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Urethral stenosis	Renal and urinary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0022 affected2,820 at risk EG003
Urinary bladder polyp	Renal and urinary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0026 affected2,820 at risk EG003
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0024 affected2,820 at risk EG003
Breast necrosis	Reproductive system and breast disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Breast pain	Reproductive system and breast disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Cervical polyp	Reproductive system and breast disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Female genital tract fistula	Reproductive system and breast disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Hysterocele	Reproductive system and breast disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Ovarian cyst	Reproductive system and breast disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Postmenopausal haemorrhage	Reproductive system and breast disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Prostatomegaly	Reproductive system and breast disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Scrotal oedema	Reproductive system and breast disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Uterine haemorrhage	Reproductive system and breast disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Uterine polyp	Reproductive system and breast disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Uterine prolapse	Reproductive system and breast disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG00219 affected2,820 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0027 affected2,820 at risk EG003
Asphyxia	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0022 affected2,820 at risk EG003
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG00214 affected2,820 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG00234 affected2,820 at risk EG003
Dyspnoea at rest	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0026 affected2,820 at risk EG003
Dyspnoea paroxysmal nocturnal	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Hydrothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0024 affected2,820 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Lung consolidation	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0022 affected2,820 at risk EG003
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0022 affected2,820 at risk EG003
Orthopnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Painful respiration	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0024 affected2,820 at risk EG003
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0022 affected2,820 at risk EG003
Pulmonary alveolar haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Pulmonary artery thrombosis	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0028 affected2,820 at risk EG003
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0022 affected2,820 at risk EG003
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG00212 affected2,820 at risk EG003
Pulmonary pain	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG00211 affected2,820 at risk EG003
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Tracheal stenosis	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Angioedema	Skin and subcutaneous tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0024 affected2,820 at risk EG003
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0022 affected2,820 at risk EG003
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0026 affected2,820 at risk EG003
Diabetic wound	Skin and subcutaneous tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0022 affected2,820 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0023 affected2,820 at risk EG003
Symmetrical drug-related intertriginous and flexural exanthema	Skin and subcutaneous tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Alcoholic	Social circumstances	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0021 affected2,820 at risk EG003
Immobile	Social circumstances	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Imprisonment	Social circumstances	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Cardiac pacemaker insertion	Surgical and medical procedures	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Transcatheter aortic valve implantation	Surgical and medical procedures	MedDRA (23.1)	Systematic Assessment	EG0000 at risk EG0010 at risk EG0020 affected2,820 at risk EG003
Aneurysm ruptured	Vascular disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Angiodysplasia	Vascular disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Aortic aneurysm	Vascular disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0022 affected2,820 at risk EG003
Aortic dissection	Vascular disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Aortic occlusion	Vascular disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Aortic stenosis	Vascular disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Arterial haemorrhage	Vascular disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Arterial occlusive disease	Vascular disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0022 affected2,820 at risk EG003
Arterial stenosis	Vascular disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Arterial thrombosis	Vascular disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Arteriosclerosis	Vascular disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Brachiocephalic arteriosclerosis	Vascular disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Circulatory collapse	Vascular disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Distributive shock	Vascular disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Embolism arterial	Vascular disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Extremity necrosis	Vascular disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0024 affected2,820 at risk EG003
Femoral artery aneurysm	Vascular disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Haematoma	Vascular disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Hypertension	Vascular disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0026 affected2,820 at risk EG003
Hypertensive crisis	Vascular disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0024 affected2,820 at risk EG003
Hypertensive emergency	Vascular disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Hypertensive urgency	Vascular disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0022 affected2,820 at risk EG003
Hypotension	Vascular disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG00237 affected2,820 at risk EG003
Hypovolaemic shock	Vascular disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0022 affected2,820 at risk EG003
Iliac artery occlusion	Vascular disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Iliac artery stenosis	Vascular disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Intermittent claudication	Vascular disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Ischaemic limb pain	Vascular disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Jugular vein thrombosis	Vascular disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Obstructive shock	Vascular disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Orthostatic hypotension	Vascular disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0025 affected2,820 at risk EG003
Peripheral arterial occlusive disease	Vascular disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0027 affected2,820 at risk EG003
Peripheral artery aneurysm	Vascular disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Peripheral artery occlusion	Vascular disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0023 affected2,820 at risk EG003
Peripheral artery stenosis	Vascular disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0023 affected2,820 at risk EG003
Peripheral artery thrombosis	Vascular disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0023 affected2,820 at risk EG003
Peripheral ischaemia	Vascular disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0026 affected2,820 at risk EG003
Peripheral vascular disorder	Vascular disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0024 affected2,820 at risk EG003
Phlebitis	Vascular disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Reperfusion injury	Vascular disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Subclavian artery occlusion	Vascular disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Thrombophlebitis	Vascular disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Thrombophlebitis superficial	Vascular disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003
Venous aneurysm	Vascular disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected2,820 at risk EG003
Venous haemorrhage	Vascular disorders	MedDRA (23.1)	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0021 affected2,820 at risk EG003

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	LCZ696 Pre-treatment	Only for pre-treatment deaths that are not included in the safety set.	1	2,834	0	0	0	0
EG001	Ramipril Pre-treatment	Only pre-treatment deaths that are not included in the safety set	3	2,835	0	0	0	0
EG002	LCZ696	Following randomization, patients received LCZ696 in titrated doses from level 1 up to level 3 (50, 100 and 200 mg twice daily). Patients were required to take a total of two pills, (one tablet from the LCZ696 pack and one capsule from Ramipril matching placebo pack) twice a day for the duration of the study. Patients randomized to LCZ who were previously treated with ACE inhibitors, receiving the last dose of that agent during the last 36 hours prior to randomization, received a valsartan bridge for one day. These patients received two doses of valsartan for 1 day in a blinded manner prior to beginning double-blind LCZ696 treatment.	220	2,820	1,146	2,820	1,769	2,820
EG003	Ramipril	Following randomization, patients received Ramipril in titrated doses from level 1 up to level 3 (1.25, 2.5 and 5 mg twice daily). Patients were required to take a total of two pills, (one capsule from the Ramipril pack and one tablet from LCZ696 matching placebo pack) twice a day for the duration of the study. Patients randomized to Ramipril who were previously treated with ACE inhibitors, receiving the last dose of that agent during the last 36 hours prior to randomization immediately started on double-blind ramipril; however, to maintain double blind/double dummy of the valsartan bridge, these patients received two doses of matching valsartan placebo for 1 day in a blinded manner prior to beginning double-blind LCZ696 placebo.	244	2,816	1,126	2,816	1,770	2,816

ID	Term
D018487	Ventricular Dysfunction, Left
D000072657	ST Elevation Myocardial Infarction
D000072658	Non-ST Elevated Myocardial Infarction

ID	Term
D018754	Ventricular Dysfunction
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D009203	Myocardial Infarction
D017202	Myocardial Ischemia
D014652	Vascular Diseases
D007238	Infarction
D007511	Ischemia
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009336	Necrosis

ID	Term
D013777	Tetrazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D014633	Valine
D000597	Amino Acids, Branched-Chain
D000596	Amino Acids
D000602	Amino Acids, Peptides, and Proteins
D000601	Amino Acids, Essential
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

ID	Title	Description
BG000	LCZ696 (Sacubitril/Valsartan)	Following randomization, patients received LCZ696 in titrated doses from level 1 up to level 3 (50, 100 and 200 mg twice daily). Patients were required to take a total of two pills, (one tablet from the LCZ696 pack and one capsule from Ramipril matching placebo pack) twice a day for the duration of the study. Patients randomized to LCZ who were previously treated with ACE inhibitors, receiving the last dose of that agent during the last 36 hours prior to randomization, received a valsartan bridge for one day. These patients received two doses of valsartan for 1 day in a blinded manner prior to beginning double-blind LCZ696 treatment.
BG001	Ramipril	Following randomization, patients received Ramipril in titrated doses from level 1 up to level 3 (1.25, 2.5 and 5 mg twice daily). Patients were required to take a total of two pills, (one capsule from the Ramipril pack and one tablet from LCZ696 matching placebo pack) twice a day for the duration of the study. Patients randomized to Ramipril who were previously treated with ACE inhibitors, receiving the last dose of that agent during the last 36 hours prior to randomization immediately started on double-blind ramipril; however, to maintain double blind/double dummy of the valsartan bridge, these patients received two doses of matching valsartan placebo for 1 day in a blinded manner prior to beginning double-blind LCZ696 placebo.
BG002	Total	Total of all reporting groups

ID	Term
C549068	sacubitril and valsartan sodium hydrate drug combination
C000717211	sacubitril
D000068756	Valsartan
D017257	Ramipril