Prevention of Serious Adverse Events Following Angiography | NCT01467466

ID	Type	Description	Link
1011387	Other Grant/Funding Number	National Health and Medical Research Council

Name	Class
The George Institute	OTHER

Label	Type	Description	Intervention Names
Saline & oral placebo	Active Comparator	IV isotonic saline and oral placebo drug capsule	Drug: IV isotonic saline Drug: Placebo
Saline & oral N-acetylcysteine	Active Comparator	IV isotonic saline and oral N-acetylcysteine drug capsule	Drug: IV isotonic saline Drug: N-acetylcysteine
Bicarbonate & oral placebo	Active Comparator	IV isotonic bicarbonate and oral placebo drug capsule	Drug: IV isotonic bicarbonate Drug: Placebo
Bicarbonate & oral N-acetylcysteine	Active Comparator	IV isotonic bicarbonate and oral N-acetylcysteine drug capsule	Drug: IV isotonic bicarbonate Drug: N-acetylcysteine

Name	Type	Description	Arm Group Labels	Other Names
IV isotonic saline	Drug	The investigators will administer 3 ml/kg of isotonic saline over 1 hour at an infusion rate of not less than 1 mL/kg per hour and not more than 3 mL/kg per hour prior to the angiographic procedure, 1-1.5ml/kg per hour during angiography, and 6 ml/kg of isotonic saline over 4 hours following the procedure at an infusion rate of not less than 1 mL/kg per hour and not more than 1.5 mL/kg per hour. Providers will retain discretion to administer larger volumes of isotonic saline (up to a maximum of 12 mL/kg) over durations of up to 12 hours pre and 12 hours post-procedure.

Measure	Description	Time Frame
Number of Participants With Serious, Adverse, Patient-Centered Events, Including Death, Need for Acute Dialysis, or Persistent Decline in Kidney Function, Comparing Intravenous Sodium Bicarbonate With Intravenous Sodium Chloride.	Death will be based on medical record and/or vital status registry documentation Need for acute dialysis will be defined as the initiation of any modality of renal replacement (intermittent hemodialysis, peritoneal dialysis, continuous renal replacement therapy, or sustained low-efficiency dialysis) Persistent decline in kidney function will be defined as an increase in serum creatinine of at least 50% from the baseline value collected pre-angiography to the measurement taken 90 days following the angiography.	Within 90 days following angiography
Number of Participants With Serious, Adverse, Patient-Centered Events, Including Death, Need for Acute Dialysis, or Persistent Decline in Kidney Function, Comparing Oral N-Acetylcysteine With Oral Placebo.	Death will be based on medical record and/or vital status registry documentation Need for acute dialysis will be defined as the initiation of any modality of renal replacement (intermittent hemodialysis, peritoneal dialysis, continuous renal replacement therapy, or sustained low-efficiency dialysis) Persistent decline in kidney function will be defined as an increase in serum creatinine of at least 50% from the baseline value collected pre-angiography to the measurement taken 90 days following the angiography.	Within 90 days following angiography

Name	Affiliation	Role
Steven D. Weisbord, MD MSc	VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Southern Arizona VA Health Care System, Tucson		Tucson	Arizona	85723	United States
Central Arkansas VHS John L. McClellan Memorial Veterans Hospital, Little Rock, AR

PubMed Identifier	Type	Citation	Retractions
29130810	Derived	Weisbord SD, Gallagher M, Jneid H, Garcia S, Cass A, Thwin SS, Conner TA, Chertow GM, Bhatt DL, Shunk K, Parikh CR, McFalls EO, Brophy M, Ferguson R, Wu H, Androsenko M, Myles J, Kaufman J, Palevsky PM; PRESERVE Trial Group. Outcomes after Angiography with Sodium Bicarbonate and Acetylcysteine. N Engl J Med. 2018 Feb 15;378(7):603-614. doi: 10.1056/NEJMoa1710933. Epub 2017 Nov 12.

ID	Title	Description
FG000	Saline & oral placebo	IV isotonic saline and oral placebo drug capsule IV isotonic saline: The investigators will administer 3 ml/kg of isotonic saline over 1 hour at an infusion rate of not less than 1 mL/kg per hour and not more than 3 mL/kg per hour prior to the angiographic procedure, 1-1.5ml/kg per hour during angiography, and 6 ml/kg of isotonic saline over 4 hours following the procedure at an infusion rate of not less than 1 mL/kg per hour and not more than 1.5 mL/kg per hour. Providers will retain discretion to administer larger volumes of isotonic saline (up to a maximum of 12 mL/kg) over durations of up to 12 hours pre and 12 hours post-procedure. Placebo: A placebo study drug capsule will be administered orally 1 hour prior to angiography, 1 hour following the procedure, and then twice daily for the next 4 days.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	May 1, 2019	May 3, 2019

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal lymphadenopathy	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0003 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG0030 events0 affected1,291 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG00015 events14 affected1,300 at risk EG00111 events10 affected1,292 at risk EG00215 events14 affected1,294 at risk EG003
Anaemia macrocytic	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Anaemia of chronic disease	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Coagulopathy	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0004 events4 affected1,300 at risk EG0012 events2 affected1,292 at risk EG0025 events4 affected1,294 at risk EG003
Haemorrhagic disorder	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0002 events2 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Heparin-induced thrombocytopenia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0003 events3 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0012 events2 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Leukocytosis	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0014 events3 affected1,292 at risk EG0022 events1 affected1,294 at risk EG003
Normochromic normocytic anaemia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0022 events2 affected1,294 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Acute coronary syndrome	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0008 events8 affected1,300 at risk EG00112 events12 affected1,292 at risk EG0022 events2 affected1,294 at risk EG003
Acute left ventricular failure	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG00020 events19 affected1,300 at risk EG00132 events29 affected1,292 at risk EG00229 events27 affected1,294 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0007 events7 affected1,300 at risk EG00110 events10 affected1,292 at risk EG0028 events6 affected1,294 at risk EG003
Angina unstable	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0004 events4 affected1,300 at risk EG00114 events14 affected1,292 at risk EG0026 events6 affected1,294 at risk EG003
Aortic valve disease	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0012 events2 affected1,292 at risk EG0022 events2 affected1,294 at risk EG003
Aortic valve disease mixed	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0002 events2 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0023 events3 affected1,294 at risk EG003
Aortic valve incompetence	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0002 events2 affected1,300 at risk EG0012 events2 affected1,292 at risk EG0024 events4 affected1,294 at risk EG003
Aortic valve stenosis	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG00044 events41 affected1,300 at risk EG00152 events47 affected1,292 at risk EG00252 events48 affected1,294 at risk EG003
Arrhythmia	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0002 events2 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0023 events3 affected1,294 at risk EG003
Arrhythmia supraventricular	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0013 events3 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Arteriospasm coronary	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG00033 events29 affected1,300 at risk EG00132 events32 affected1,292 at risk EG00231 events30 affected1,294 at risk EG003
Atrial flutter	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0004 events4 affected1,300 at risk EG0015 events5 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Atrial tachycardia	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Atrial thrombosis	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Atrioventricular block	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0002 events2 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Atrioventricular block complete	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0002 events2 affected1,300 at risk EG0012 events2 affected1,292 at risk EG0023 events3 affected1,294 at risk EG003
Atrioventricular block first degree	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Atrioventricular block second degree	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0013 events3 affected1,292 at risk EG0024 events4 affected1,294 at risk EG003
Bradycardia	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0005 events5 affected1,300 at risk EG0016 events6 affected1,292 at risk EG0024 events4 affected1,294 at risk EG003
Bundle branch block left	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0002 events2 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0004 events4 affected1,300 at risk EG0014 events4 affected1,292 at risk EG0023 events3 affected1,294 at risk EG003
Cardiac failure acute	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0004 events4 affected1,300 at risk EG00111 events11 affected1,292 at risk EG0028 events8 affected1,294 at risk EG003
Cardiac failure chronic	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0024 events4 affected1,294 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG00046 events37 affected1,300 at risk EG00157 events51 affected1,292 at risk EG00270 events61 affected1,294 at risk EG003
Cardiac perforation	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Cardiac tamponade	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0002 events2 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Cardiac valve disease	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0012 events2 affected1,292 at risk EG0023 events2 affected1,294 at risk EG003
Cardiogenic shock	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0004 events4 affected1,300 at risk EG0013 events3 affected1,292 at risk EG0023 events3 affected1,294 at risk EG003
Cardiomyopathy	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0013 events3 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Cardiorenal syndrome	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Cardio-respiratory arrest	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Cardiovascular deconditioning	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Cardiovascular disorder	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Conduction disorder	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Cor pulmonale	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG000186 events163 affected1,300 at risk EG001198 events178 affected1,292 at risk EG002213 events189 affected1,294 at risk EG003
Coronary artery dissection	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0002 events2 affected1,300 at risk EG0012 events2 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Coronary artery occlusion	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0023 events3 affected1,294 at risk EG003
Coronary artery perforation	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Coronary artery stenosis	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0008 events8 affected1,300 at risk EG0014 events4 affected1,292 at risk EG0027 events7 affected1,294 at risk EG003
Coronary artery thrombosis	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Coronary ostial stenosis	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Degenerative mitral valve disease	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Diastolic dysfunction	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0003 events3 affected1,300 at risk EG0014 events4 affected1,292 at risk EG0025 events5 affected1,294 at risk EG003
Left ventricular dysfunction	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Left ventricular failure	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0022 events2 affected1,294 at risk EG003
Microvascular coronary artery disease	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Mitral valve disease	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Mitral valve incompetence	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0007 events7 affected1,300 at risk EG0019 events9 affected1,292 at risk EG00214 events11 affected1,294 at risk EG003
Mitral valve prolapse	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Mitral valve stenosis	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0024 events4 affected1,294 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0002 events2 affected1,300 at risk EG0016 events6 affected1,292 at risk EG0023 events3 affected1,294 at risk EG003
Myocardial ischaemia	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0006 events6 affected1,300 at risk EG0016 events6 affected1,292 at risk EG0023 events3 affected1,294 at risk EG003
Nodal arrhythmia	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Palpitations	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Pericardial effusion	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0014 events4 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Pericarditis	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0023 events3 affected1,294 at risk EG003
Pulseless electrical activity	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Restrictive cardiomyopathy	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Rheumatic heart disease	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Right ventricular dysfunction	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Right ventricular failure	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0022 events2 affected1,294 at risk EG003
Sinus arrest	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0022 events1 affected1,294 at risk EG003
Sinus bradycardia	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Sinus node dysfunction	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0014 events3 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Sinus tachycardia	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Supraventricular tachycardia	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0005 events5 affected1,300 at risk EG0012 events2 affected1,292 at risk EG0022 events2 affected1,294 at risk EG003
Tachyarrhythmia	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0022 events2 affected1,294 at risk EG003
Tachycardia	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0002 events2 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Ventricular arrhythmia	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Ventricular extrasystoles	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Ventricular fibrillation	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Ventricular tachycardia	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0006 events6 affected1,300 at risk EG0018 events7 affected1,292 at risk EG00210 events9 affected1,294 at risk EG003
Bicuspid aortic valve	Congenital, familial and genetic disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Haemorrhagic arteriovenous malformation	Congenital, familial and genetic disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Phimosis	Congenital, familial and genetic disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Von Willebrand's disease	Congenital, familial and genetic disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Deafness neurosensory	Ear and labyrinth disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Adrenal insufficiency	Endocrine disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0012 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Goitre	Endocrine disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Hyperthyroidism	Endocrine disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Inappropriate antidiuretic hormone secretion	Endocrine disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Blindness	Eye disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Cataract	Eye disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0013 events2 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Diplopia	Eye disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Retinal detachment	Eye disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Uveitis	Eye disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0023 events1 affected1,294 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Acquired oesophageal web	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Chronic gastrointestinal bleeding	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Coeliac artery compression syndrome	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Colitis ischaemic	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Colonic pseudo-obstruction	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Dieulafoy's vascular malformation	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Diverticular perforation	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Diverticulum	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Diverticulum intestinal haemorrhagic	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Duodenal stenosis	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Duodenal ulcer	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Duodenal ulcer perforation	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0022 events2 affected1,294 at risk EG003
Enterocolitis haemorrhagic	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Femoral hernia incarcerated	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Gastric ulcer	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Gastritis erosive	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0005 events5 affected1,300 at risk EG0014 events3 affected1,292 at risk EG0025 events5 affected1,294 at risk EG003
Gastrointestinal necrosis	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Gastrointestinal perforation	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0012 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Gastrointestinal polyp haemorrhage	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0013 events3 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Gastrointestinal ulcer haemorrhage	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0022 events2 affected1,294 at risk EG003
Haematemesis	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Haemorrhagic erosive gastritis	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0002 events2 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Hiatus hernia	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Ileus	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0022 events2 affected1,294 at risk EG003
Impaired gastric emptying	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Intestinal ischaemia	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Intestinal mass	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0002 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Large intestinal ulcer haemorrhage	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Large intestine polyp	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0022 events2 affected1,294 at risk EG003
Mallory-Weiss syndrome	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Melaena	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Oesophageal disorder	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Oesophageal rupture	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Oesophageal stenosis	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Oesophageal ulcer haemorrhage	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Oesophageal varices haemorrhage	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Oesophagitis	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Pancreatic failure	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Peptic ulcer	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Peritoneal haemorrhage	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Pneumoperitoneum	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Retroperitoneal haematoma	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0012 events2 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Retroperitoneal haemorrhage	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0013 events3 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0024 events4 affected1,294 at risk EG003
Umbilical hernia	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0014 events3 affected1,292 at risk EG0022 events2 affected1,294 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0022 events2 affected1,294 at risk EG003
Adverse drug reaction	General disorders	MedDRA (10.0)	Systematic Assessment	EG0003 events3 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Asthenia	General disorders	MedDRA (10.0)	Systematic Assessment	EG0005 events4 affected1,300 at risk EG0012 events2 affected1,292 at risk EG0024 events3 affected1,294 at risk EG003
Catheter site haemorrhage	General disorders	MedDRA (10.0)	Systematic Assessment	EG0002 events2 affected1,300 at risk EG0012 events2 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Catheter site pain	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Chest discomfort	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Chest pain	General disorders	MedDRA (10.0)	Systematic Assessment	EG0006 events6 affected1,300 at risk EG00110 events10 affected1,292 at risk EG00210 events10 affected1,294 at risk EG003
Complication associated with device	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Death	General disorders	MedDRA (10.0)	Systematic Assessment	EG0002 events2 affected1,300 at risk EG0012 events2 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Drug intolerance	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Drug withdrawal syndrome	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Extravasation	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Gait disturbance	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Hernia	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Impaired healing	General disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Malaise	General disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Mucosal inflammation	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0013 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Multiple organ dysfunction syndrome	General disorders	MedDRA (10.0)	Systematic Assessment	EG0003 events3 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0017 events7 affected1,292 at risk EG0023 events2 affected1,294 at risk EG003
Oedema peripheral	General disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Pain	General disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Pyrexia	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0022 events2 affected1,294 at risk EG003
Sudden cardiac death	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0022 events2 affected1,294 at risk EG003
Systemic inflammatory response syndrome	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Ulcer haemorrhage	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Vascular stent restenosis	General disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0022 events2 affected1,294 at risk EG003
Vascular stent thrombosis	General disorders	MedDRA (10.0)	Systematic Assessment	EG0004 events2 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Vessel puncture site thrombosis	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Cholangitis	Hepatobiliary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0022 events2 affected1,294 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0012 events2 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Chronic hepatic failure	Hepatobiliary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Cryptogenic cirrhosis	Hepatobiliary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Gallbladder disorder	Hepatobiliary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0023 events1 affected1,294 at risk EG003
Gallbladder enlargement	Hepatobiliary disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Haemorrhagic hepatic cyst	Hepatobiliary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0012 events2 affected1,292 at risk EG0022 events2 affected1,294 at risk EG003
Hepatic congestion	Hepatobiliary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Hepatic haemorrhage	Hepatobiliary disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Ischaemic hepatitis	Hepatobiliary disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Liver disorder	Hepatobiliary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Contrast media allergy	Immune system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Contrast media reaction	Immune system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Drug hypersensitivity	Immune system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Selective IgA immunodeficiency	Immune system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Abdominal wall abscess	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Abscess limb	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Abscess neck	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Appendicitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Arthritis bacterial	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Atypical pneumonia	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Bacteraemia	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Bacterial infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Bronchitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0013 events3 affected1,292 at risk EG0022 events2 affected1,294 at risk EG003
Cardiac valve vegetation	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Cellulitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0009 events9 affected1,300 at risk EG0017 events7 affected1,292 at risk EG0028 events8 affected1,294 at risk EG003
Cellulitis gangrenous	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Cellulitis staphylococcal	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Clostridium bacteraemia	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Clostridium difficile colitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Clostridium difficile infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0003 events3 affected1,300 at risk EG0012 events2 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Coccidioidomycosis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Cystitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Cystitis klebsiella	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Cytomegalovirus colitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Cytomegalovirus infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Dengue fever	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Device related infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0022 events1 affected1,294 at risk EG003
Diabetic foot infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0003 events2 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0022 events2 affected1,294 at risk EG003
Diverticulitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Diverticulitis intestinal haemorrhagic	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Endocarditis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0003 events1 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Enterobacter bacteraemia	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Enterobacter pneumonia	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Enterococcal bacteraemia	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Enterocolitis infectious	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Epididymitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Escherichia urinary tract infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Extradural abscess	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Folliculitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Fungal endocarditis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Gangrene	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0004 events4 affected1,300 at risk EG0013 events3 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Gas gangrene	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0013 events3 affected1,292 at risk EG0022 events2 affected1,294 at risk EG003
Gastroenteritis norovirus	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0024 events4 affected1,294 at risk EG003
Graft infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Groin abscess	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Groin infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Haemophilus infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Helicobacter gastritis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Herpes zoster	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Incision site cellulitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0002 events2 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0023 events3 affected1,294 at risk EG003
Infected cyst	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Influenza	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0002 events2 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0022 events2 affected1,294 at risk EG003
Localised infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Mediastinitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0022 events1 affected1,294 at risk EG003
Necrotising fasciitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Oral candidiasis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Osteomyelitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0008 events8 affected1,300 at risk EG00110 events8 affected1,292 at risk EG0027 events6 affected1,294 at risk EG003
Osteomyelitis chronic	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Peritonitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Pneumonia	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG00025 events24 affected1,300 at risk EG00124 events21 affected1,292 at risk EG00227 events24 affected1,294 at risk EG003
Pneumonia bacterial	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0002 events2 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Pneumonia klebsiella	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Pneumonia mycoplasmal	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Pneumonia staphylococcal	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Pneumonia streptococcal	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Post procedural cellulitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0002 events2 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Post procedural infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Postoperative wound infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0006 events5 affected1,300 at risk EG0016 events5 affected1,292 at risk EG0025 events4 affected1,294 at risk EG003
Pyelonephritis acute	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0022 events2 affected1,294 at risk EG003
Rash pustular	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0022 events1 affected1,294 at risk EG003
Respiratory syncytial virus infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Retroperitoneal infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Sepsis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0006 events6 affected1,300 at risk EG0017 events6 affected1,292 at risk EG0029 events7 affected1,294 at risk EG003
Septic shock	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0013 events3 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Serratia infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Serratia sepsis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Skin infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Soft tissue infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Staphylococcal infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0022 events1 affected1,294 at risk EG003
Staphylococcal sepsis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Streptococcal sepsis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Subcutaneous abscess	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0002 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0009 events8 affected1,300 at risk EG00113 events11 affected1,292 at risk EG00214 events14 affected1,294 at risk EG003
Urinary tract infection bacterial	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Urinary tract infection pseudomonal	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Urosepsis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Viral diarrhoea	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Wound infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0003 events3 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Anaemia postoperative	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0004 events4 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0027 events6 affected1,294 at risk EG003
Anaesthetic complication	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Animal bite	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Ankle fracture	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Aortic injury	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Arteriovenous graft aneurysm	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Bite	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Brain contusion	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Cardiac procedure complication	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0003 events3 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Cerebral hyperperfusion syndrome	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Confusion postoperative	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Endotracheal intubation complication	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0022 events2 affected1,294 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0005 events5 affected1,300 at risk EG0014 events4 affected1,292 at risk EG0026 events6 affected1,294 at risk EG003
Fat embolism	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Foot fracture	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Fracture	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Gastroenteritis radiation	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Gastrointestinal stoma complication	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0023 events3 affected1,294 at risk EG003
Humerus fracture	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Inappropriate schedule of drug administration	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Incision site haematoma	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Incorrect route of drug administration	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Injury	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Mental status changes postoperative	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Peroneal nerve injury	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Post procedural complication	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0003 events3 affected1,300 at risk EG0013 events3 affected1,292 at risk EG0023 events2 affected1,294 at risk EG003
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0014 events4 affected1,292 at risk EG0025 events5 affected1,294 at risk EG003
Post procedural myocardial infarction	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Post procedural pulmonary embolism	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Post procedural stroke	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0022 events2 affected1,294 at risk EG003
Postoperative fever	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Postoperative ileus	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Postoperative respiratory distress	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Postoperative respiratory failure	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Postoperative thoracic procedure complication	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0022 events2 affected1,294 at risk EG003
Postpericardiotomy syndrome	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Procedural complication	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0002 events2 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Procedural hypertension	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Procedural hypotension	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0004 events4 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Procedural nausea	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Procedural pneumothorax	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Radiation proctitis	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Road traffic accident	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0012 events2 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Subarachnoid haemorrhage	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Thermal burn	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0012 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Transplant dysfunction	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Vascular access complication	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Vascular access site pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Vascular graft occlusion	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0002 events2 affected1,300 at risk EG0013 events3 affected1,292 at risk EG0023 events3 affected1,294 at risk EG003
Wound complication	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0003 events3 affected1,300 at risk EG0012 events2 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Wound haemorrhage	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0022 events2 affected1,294 at risk EG003
Anticoagulation drug level above therapeutic	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Anticoagulation drug level below therapeutic	Investigations	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Blood creatine phosphokinase MB increased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Blood creatinine increased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0002 events2 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Blood potassium decreased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Blood pressure increased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0012 events2 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Ejection fraction decreased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Electrocardiogram ST segment elevation	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Haematocrit decreased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Haemoglobin decreased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
International normalised ratio increased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0012 events2 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Laboratory test abnormal	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Left ventricular end-diastolic pressure increased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Pulmonary arterial wedge pressure increased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Transaminases increased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Troponin increased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0024 events4 affected1,294 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0013 events3 affected1,292 at risk EG0023 events3 affected1,294 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0022 events2 affected1,294 at risk EG003
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0003 events3 affected1,300 at risk EG0013 events3 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Failure to thrive	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Fluid overload	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0005 events5 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0028 events7 affected1,294 at risk EG003
Gout	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0013 events3 affected1,292 at risk EG0022 events2 affected1,294 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0002 events2 affected1,300 at risk EG0013 events3 affected1,292 at risk EG0025 events4 affected1,294 at risk EG003
Hyperinsulinaemic hypoglycaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0002 events1 affected1,300 at risk EG0013 events3 affected1,292 at risk EG0025 events5 affected1,294 at risk EG003
Hypervolaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0004 events4 affected1,300 at risk EG0012 events2 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0012 events2 affected1,292 at risk EG0023 events3 affected1,294 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0012 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Hypophagia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Hypovolaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Lactic acidosis	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Compartment syndrome	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0022 events1 affected1,294 at risk EG003
Gouty arthritis	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Muscle haemorrhage	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0012 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0023 events2 affected1,294 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Myopathy	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0002 events2 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0024 events4 affected1,294 at risk EG003
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0012 events1 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0002 events1 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Anal squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Angiosarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Benign neoplasm of adrenal gland	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Bladder cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Brain neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Cardiac myxoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Clear cell renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Colon neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0012 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Gastrointestinal tract adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Hepatic cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Hepatic cancer stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0023 events1 affected1,294 at risk EG003
Hepatocellular carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Intestinal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Leiomyosarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0002 events2 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0022 events2 affected1,294 at risk EG003
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0024 events1 affected1,294 at risk EG003
Metastatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Metastatic renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0012 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Prostate cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Rectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0002 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0012 events2 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Small cell lung cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0002 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0023 events1 affected1,294 at risk EG003
Squamous cell carcinoma of lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0002 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0013 events2 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Balance disorder	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Basal ganglia haemorrhage	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Carotid arteriosclerosis	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Carotid artery occlusion	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Carotid artery stenosis	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG00014 events12 affected1,300 at risk EG0017 events7 affected1,292 at risk EG0024 events4 affected1,294 at risk EG003
Cerebellar infarction	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Cerebral infarction	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0012 events2 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0009 events7 affected1,300 at risk EG0016 events6 affected1,292 at risk EG0028 events8 affected1,294 at risk EG003
Cervical myelopathy	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Dementia	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Diabetic neuropathy	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Dizziness	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Dizziness postural	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Dysarthria	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Embolic stroke	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0002 events2 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Encephalopathy	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0013 events3 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Facial paralysis	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Facial paresis	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Haemorrhage intracranial	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Haemorrhagic stroke	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0003 events2 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Headache	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Hemiparesis	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Hepatic encephalopathy	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Hypersomnia	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Hypoglycaemic seizure	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Hypoglycaemic unconsciousness	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Ischaemic stroke	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Lacunar infarction	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Loss of consciousness	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0022 events2 affected1,294 at risk EG003
Metabolic encephalopathy	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Movement disorder	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Nerve root compression	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Normal pressure hydrocephalus	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Parkinson's disease	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Presyncope	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Radicular pain	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Sedation	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Seizure	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0012 events2 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Syncope	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0002 events2 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0024 events4 affected1,294 at risk EG003
Toxic encephalopathy	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0012 events2 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0003 events3 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0023 events2 affected1,294 at risk EG003
Tremor	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Uraemic encephalopathy	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Device malfunction	Product Issues	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Device occlusion	Product Issues	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Alcoholism	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Delirium	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG0004 events4 affected1,300 at risk EG0013 events3 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Delirium tremens	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0022 events1 affected1,294 at risk EG003
Depression suicidal	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0012 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Drug use disorder	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Major depression	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Mental status changes	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0013 events3 affected1,292 at risk EG0022 events2 affected1,294 at risk EG003
Panic attack	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG0002 events2 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Post-traumatic stress disorder	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Psychiatric decompensation	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Psychotic disorder	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Schizophrenia	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Substance use disorder	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Suicidal ideation	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG00043 events41 affected1,300 at risk EG00181 events67 affected1,292 at risk EG00288 events73 affected1,294 at risk EG003
Azotaemia	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Bladder mass	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0003 events3 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Bladder outlet obstruction	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Calculus urinary	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Chronic kidney disease	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0004 events4 affected1,300 at risk EG0013 events3 affected1,292 at risk EG0023 events2 affected1,294 at risk EG003
Cystitis haemorrhagic	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
End stage renal disease	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0022 events2 affected1,294 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0002 events2 affected1,300 at risk EG0013 events3 affected1,292 at risk EG0024 events4 affected1,294 at risk EG003
Nephropathy toxic	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0003 events3 affected1,300 at risk EG0013 events3 affected1,292 at risk EG0023 events3 affected1,294 at risk EG003
Nephrotic syndrome	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Pelvi-ureteric obstruction	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Polyuria	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Renal artery occlusion	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Renal artery stenosis	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0022 events2 affected1,294 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0013 events3 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Renal impairment	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Renal mass	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0022 events2 affected1,294 at risk EG003
Renal tubular necrosis	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0004 events4 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Ureteric obstruction	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0013 events1 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Ureterolithiasis	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Urinary fistula	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0012 events2 affected1,292 at risk EG0022 events2 affected1,294 at risk EG003
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA (10.0)	Systematic Assessment	EG0003 events2 affected1,300 at risk EG0012 events2 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Prostatitis	Reproductive system and breast disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Scrotal oedema	Reproductive system and breast disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Acute interstitial pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0002 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0003 events3 affected1,300 at risk EG0012 events2 affected1,292 at risk EG0024 events4 affected1,294 at risk EG003
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0022 events2 affected1,294 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0016 events6 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0012 events2 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0013 events3 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Bronchial hyperreactivity	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Bronchial secretion retention	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Bronchiectasis	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0007 events7 affected1,300 at risk EG00116 events14 affected1,292 at risk EG00219 events16 affected1,294 at risk EG003
Chylothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Diaphragmatic paralysis	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0012 events2 affected1,292 at risk EG0024 events4 affected1,294 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Emphysema	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Hypercapnia	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0012 events2 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Increased viscosity of bronchial secretion	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Mediastinal haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0023 events3 affected1,294 at risk EG003
Orthopnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0008 events8 affected1,300 at risk EG00111 events10 affected1,292 at risk EG00211 events9 affected1,294 at risk EG003
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0003 events3 affected1,300 at risk EG0015 events5 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0003 events3 affected1,300 at risk EG0015 events5 affected1,292 at risk EG0024 events3 affected1,294 at risk EG003
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0002 events2 affected1,300 at risk EG0012 events2 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0002 events2 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0008 events8 affected1,300 at risk EG0012 events2 affected1,292 at risk EG0026 events6 affected1,294 at risk EG003
Respiratory acidosis	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Respiratory alkalosis	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0005 events5 affected1,300 at risk EG0015 events5 affected1,292 at risk EG0025 events5 affected1,294 at risk EG003
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Tonsillar ulcer	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0003 events3 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Night sweats	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Rash vesicular	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Skin haemorrhage	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0007 events4 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0025 events3 affected1,294 at risk EG003
Subcutaneous emphysema	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Alcohol detoxification	Surgical and medical procedures	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Aortic valve replacement	Surgical and medical procedures	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Arterial ligation	Surgical and medical procedures	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Bladder catheterisation	Surgical and medical procedures	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Catheter management	Surgical and medical procedures	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Coronary artery bypass	Surgical and medical procedures	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Dialysis	Surgical and medical procedures	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Drug therapy	Surgical and medical procedures	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Foot amputation	Surgical and medical procedures	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Immune tolerance induction	Surgical and medical procedures	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Intra-aortic balloon placement	Surgical and medical procedures	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Leg amputation	Surgical and medical procedures	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Nutritional supplementation	Surgical and medical procedures	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Parenteral nutrition	Surgical and medical procedures	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Preoperative care	Surgical and medical procedures	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Prophylaxis	Surgical and medical procedures	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Spinal decompression	Surgical and medical procedures	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Thrombolysis	Surgical and medical procedures	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Toe amputation	Surgical and medical procedures	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0022 events2 affected1,294 at risk EG003
Tooth extraction	Surgical and medical procedures	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Wound drainage	Surgical and medical procedures	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Air embolism	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Angiodysplasia	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Aortic aneurysm	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0004 events4 affected1,300 at risk EG0016 events6 affected1,292 at risk EG0025 events5 affected1,294 at risk EG003
Aortic dissection	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Arteriosclerosis	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0008 events6 affected1,300 at risk EG0012 events2 affected1,292 at risk EG0022 events2 affected1,294 at risk EG003
Dry gangrene	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Essential hypertension	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Extremity necrosis	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Femoral artery dissection	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Haematoma	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0004 events4 affected1,300 at risk EG0012 events2 affected1,292 at risk EG0025 events5 affected1,294 at risk EG003
Haemodynamic instability	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Haemorrhage	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Hypertension	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0013 events3 affected1,292 at risk EG0025 events5 affected1,294 at risk EG003
Hypertensive crisis	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0005 events5 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0027 events7 affected1,294 at risk EG003
Hypertensive emergency	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0003 events3 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Hypoperfusion	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Hypotension	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0007 events7 affected1,300 at risk EG0017 events7 affected1,292 at risk EG0029 events8 affected1,294 at risk EG003
Iliac artery occlusion	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0002 events2 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0022 events1 affected1,294 at risk EG003
Intermittent claudication	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0012 events2 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Labile hypertension	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Neurogenic shock	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Orthostatic hypotension	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0006 events6 affected1,300 at risk EG0012 events2 affected1,292 at risk EG0022 events2 affected1,294 at risk EG003
Peripheral arterial occlusive disease	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG00012 events11 affected1,300 at risk EG00110 events9 affected1,292 at risk EG0023 events3 affected1,294 at risk EG003
Peripheral artery aneurysm	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0012 events2 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Peripheral artery dissection	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Peripheral artery occlusion	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0002 events2 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Peripheral artery stenosis	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Peripheral artery thrombosis	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Peripheral embolism	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Peripheral ischaemia	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0002 events2 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Peripheral vascular disorder	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG00010 events8 affected1,300 at risk EG0013 events3 affected1,292 at risk EG0027 events7 affected1,294 at risk EG003
Peripheral venous disease	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Shock	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0002 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Shock haemorrhagic	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Subclavian artery stenosis	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Subclavian steal syndrome	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Temporal arteritis	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Thrombophlebitis superficial	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Thrombosis	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Malnutrition	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003

ID	Title	Description
BG000	Saline & oral placebo	IV isotonic saline and oral placebo drug capsule IV isotonic saline: The investigators will administer 3 ml/kg of isotonic saline over 1 hour at an infusion rate of not less than 1 mL/kg per hour and not more than 3 mL/kg per hour prior to the angiographic procedure, 1-1.5ml/kg per hour during angiography, and 6 ml/kg of isotonic saline over 4 hours following the procedure at an infusion rate of not less than 1 mL/kg per hour and not more than 1.5 mL/kg per hour. Providers will retain discretion to administer larger volumes of isotonic saline (up to a maximum of 12 mL/kg) over durations of up to 12 hours pre and 12 hours post-procedure. Placebo: A placebo study drug capsule will be administered orally 1 hour prior to angiography, 1 hour following the procedure, and then twice daily for the next 4 days.
BG001	Saline & oral N-acetylcysteine	IV isotonic saline and oral N-acetylcysteine drug capsule IV isotonic saline: The investigators will administer 3 ml/kg of isotonic saline over 1 hour at an infusion rate of not less than 1 mL/kg per hour and not more than 3 mL/kg per hour prior to the angiographic procedure, 1-1.5ml/kg per hour during angiography, and 6 ml/kg of isotonic saline over 4 hours following the procedure at an infusion rate of not less than 1 mL/kg per hour and not more than 1.5 mL/kg per hour. Providers will retain discretion to administer larger volumes of isotonic saline (up to a maximum of 12 mL/kg) over durations of up to 12 hours pre and 12 hours post-procedure. N-acetylcysteine: NAC will be administered at a dose of 1200mg orally 1 hour prior to angiography, 1 hour following the procedure, and then twice daily for the next 4 days.
BG002	Bicarbonate & oral placebo	IV isotonic bicarbonate and oral placebo drug capsule IV isotonic bicarbonate: The investigators will administer 3 ml/kg of isotonic bicarbonate over 1 hour at an infusion rate of not less than 1 mL/kg per hour and not more than 3 mL/kg per hour prior to the angiographic procedure, 1-1.5ml/kg per hour during angiography, and 6 ml/kg of isotonic bicarbonate over 4 hours following the procedure at an infusion rate of not less than 1 mL/kg per hour and not more than 1.5 mL/kg per hour. Providers will retain discretion to administer larger volumes of isotonic bicarbonate (up to a maximum of 12 mL/kg) over durations of up to 12 hours pre and 12 hours post-procedure. Placebo: A placebo study drug capsule will be administered orally 1 hour prior to angiography, 1 hour following the procedure, and then twice daily for the next 4 days.
BG003	Bicarbonate & oral N-acetylcysteine	IV isotonic bicarbonate and oral N-acetylcysteine drug capsule IV isotonic bicarbonate: The investigators will administer 3 ml/kg of isotonic bicarbonate over 1 hour at an infusion rate of not less than 1 mL/kg per hour and not more than 3 mL/kg per hour prior to the angiographic procedure, 1-1.5ml/kg per hour during angiography, and 6 ml/kg of isotonic bicarbonate over 4 hours following the procedure at an infusion rate of not less than 1 mL/kg per hour and not more than 1.5 mL/kg per hour. Providers will retain discretion to administer larger volumes of isotonic bicarbonate (up to a maximum of 12 mL/kg) over durations of up to 12 hours pre and 12 hours post-procedure. N-acetylcysteine: NAC will be administered at a dose of 1200mg orally 1 hour prior to angiography, 1 hour following the procedure, and then twice daily for the next 4 days.
BG004	Total	Total of all reporting groups

ID	Term
D058186	Acute Kidney Injury
D007674	Kidney Diseases
D003324	Coronary Artery Disease

ID	Term
D051437	Renal Insufficiency
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases

ID	Term
D002712	Chlorides
D006851	Hydrochloric Acid
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017670	Sodium Compounds
D003545	Cysteine
D000603	Amino Acids, Sulfur
D013457	Sulfur Compounds
D009930	Organic Chemicals
D000596	Amino Acids
D000602	Amino Acids, Peptides, and Proteins

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	IV isotonic saline & oral placebo	IV isotonic saline and oral placebo drug capsule IV isotonic saline: The investigators will administer 3 ml/kg of isotonic saline over 1 hour at an infusion rate of not less than 1 mL/kg per hour and not more than 3 mL/kg per hour prior to the angiographic procedure, 1-1.5ml/kg per hour during angiography, and 6 ml/kg of isotonic saline over 4 hours following the procedure at an infusion rate of not less than 1 mL/kg per hour and not more than 1.5 mL/kg per hour. Providers will retain discretion to administer larger volumes of isotonic saline (up to a maximum of 12 mL/kg) over durations of up to 12 hours pre and 12 hours post-procedure. Placebo: A placebo study drug capsule will be administered orally 1 hour prior to angiography, 1 hour following the procedure, and then twice daily for the next 4 days.	28	1,300	941	1,300	61	1,300
EG001	IV isotonic saline & oral N-acetylcysteine	IV isotonic saline and oral N-acetylcysteine drug capsule IV isotonic saline: The investigators will administer 3 ml/kg of isotonic saline over 1 hour at an infusion rate of not less than 1 mL/kg per hour and not more than 3 mL/kg per hour prior to the angiographic procedure, 1-1.5ml/kg per hour during angiography, and 6 ml/kg of isotonic saline over 4 hours following the procedure at an infusion rate of not less than 1 mL/kg per hour and not more than 1.5 mL/kg per hour. Providers will retain discretion to administer larger volumes of isotonic saline (up to a maximum of 12 mL/kg) over durations of up to 12 hours pre and 12 hours post-procedure. N-acetylcysteine: NAC will be administered at a dose of 1200mg orally 1 hour prior to angiography, 1 hour following the procedure, and then twice daily for the next 4 days.	40	1,292	1,040	1,292	158	1,292
EG002	IV isotonic bicarbonate & oral placebo	IV isotonic bicarbonate and oral placebo drug capsule IV isotonic bicarbonate: The investigators will administer 3 ml/kg of isotonic bicarbonate over 1 hour at an infusion rate of not less than 1 mL/kg per hour and not more than 3 mL/kg per hour prior to the angiographic procedure, 1-1.5ml/kg per hour during angiography, and 6 ml/kg of isotonic bicarbonate over 4 hours following the procedure at an infusion rate of not less than 1 mL/kg per hour and not more than 1.5 mL/kg per hour. Providers will retain discretion to administer larger volumes of isotonic bicarbonate (up to a maximum of 12 mL/kg) over durations of up to 12 hours pre and 12 hours post-procedure. Placebo: A placebo study drug capsule will be administered orally 1 hour prior to angiography, 1 hour following the procedure, and then twice daily for the next 4 days.	33	1,294	1,083	1,294	83	1,294
EG003	IV isotonic bicarbonate & oral N-acetylcysteine	IV isotonic bicarbonate and oral N-acetylcysteine drug capsule IV isotonic bicarbonate: The investigators will administer 3 ml/kg of isotonic bicarbonate over 1 hour at an infusion rate of not less than 1 mL/kg per hour and not more than 3 mL/kg per hour prior to the angiographic procedure, 1-1.5ml/kg per hour during angiography, and 6 ml/kg of isotonic bicarbonate over 4 hours following the procedure at an infusion rate of not less than 1 mL/kg per hour and not more than 1.5 mL/kg per hour. Providers will retain discretion to administer larger volumes of isotonic bicarbonate (up to a maximum of 12 mL/kg) over durations of up to 12 hours pre and 12 hours post-procedure. N-acetylcysteine: NAC will be administered at a dose of 1200mg orally 1 hour prior to angiography, 1 hour following the procedure, and then twice daily for the next 4 days.	28	1,291	941	1,291	170	1,291

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Atrial Fibrillation	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG0030 events0 affected1,291 at risk
Cardiac Failure Congestive	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Palpitations	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Tachycardia	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Ear Discomfort	Ear and labyrinth disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Visual Impairment	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Abdominal Discomfort	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0013 events3 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Abdominal Distension	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Abdominal Pain	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0002 events2 affected1,300 at risk EG0012 events2 affected1,292 at risk EG0022 events2 affected1,294 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0013 events3 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0008 events8 affected1,300 at risk EG0017 events7 affected1,292 at risk EG00214 events14 affected1,294 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0006 events6 affected1,300 at risk EG00140 events40 affected1,292 at risk EG0024 events4 affected1,294 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Frequent Bowel Movements	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Functional Gastrointestinal Disorder	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Gastrointestinal Disorder	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Gastrooesophageal Reflux Disease	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0013 events3 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Hyperchlorhydria	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0009 events9 affected1,300 at risk EG00131 events31 affected1,292 at risk EG00215 events15 affected1,294 at risk EG003
Oesophageal Irritation	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Oesophageal pain	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Oesophagitis	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0004 events4 affected1,300 at risk EG00112 events11 affected1,292 at risk EG0029 events9 affected1,294 at risk EG003
Asthenia	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Catheter site phlebitis	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Chest discomfort	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Chest Pain	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Chills	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Face oedema	General disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Infusion site extravasation	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Infusion site pruritus	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Infusion site reaction	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Oedema	General disorders	MedDRA (10.0)	Systematic Assessment	EG0002 events2 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Oedema peripheral	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Sensation of foreign body	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Contrast media allergy	Immune system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Cellulitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Influenza	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Pharyngitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Post procedural oedema	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Procedural hypertension	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Blood urine present	Investigations	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Left ventricular end-diastolic pressure increased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0013 events3 affected1,292 at risk EG0022 events2 affected1,294 at risk EG003
Fluid overload	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0002 events2 affected1,300 at risk EG0013 events3 affected1,292 at risk EG0022 events2 affected1,294 at risk EG003
Fluid retention	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Hypervolaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Dizziness	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0004 events4 affected1,300 at risk EG0018 events8 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Dizziness postural	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0013 events3 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Headache	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0004 events4 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0022 events2 affected1,294 at risk EG003
Presyncope	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Nightmare	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Chronic kidney disease	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Micturition urgency	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Pollakiuria	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Renal pain	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0013 events3 affected1,292 at risk EG0022 events2 affected1,294 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0022 events2 affected1,294 at risk EG003
Throat irritation	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0012 events2 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Throat tightness	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0003 events3 affected1,300 at risk EG0012 events2 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0003 events3 affected1,300 at risk EG0012 events2 affected1,292 at risk EG0022 events2 affected1,294 at risk EG003
Rash generalised	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Rash papular	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0003 events3 affected1,300 at risk EG0012 events2 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Skin odour abnormal	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0010 events0 affected1,292 at risk EG0021 events1 affected1,294 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Flushing	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0012 events2 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003
Hypertension	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0023 events3 affected1,294 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,300 at risk EG0011 events1 affected1,292 at risk EG0020 events0 affected1,294 at risk EG003