ION US Post-Approval Study | NCT01422889

Label	Type	Description	Intervention Names
ION Registry		The ION Registry population was designed to collect real world safety and clinical outcomes data. There were 1120 subjects were enrolled, however 9 subjects did not receive a study stent therefore 1111 subjects were eligible for follow up.	Device: ION™ Coronary Stent System

Name	Type	Description	Arm Group Labels	Other Names
ION™ Coronary Stent System	Device	This study is intended to evaluate the ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent System across a range of institutions and physician users to observe and assess subject outcomes and technology performance in a real-world setting.

Measure	Description	Time Frame
Cardiac Death or Myocardial Infarction (CD/MI)	Cardiac Death or myocardial infarction (CD/MI) in the ION registry population. For the protocol specified primary endpoint analysis including data pooled from the PERSEUS SV, PERSEUS WH and TE Prove patient populations please see the citations.	12 Months

Measure	Description	Time Frame
Stent Thrombosis	Academic Research Consortium (ARC) defined (definite/probable) stent thrombosis (ST) in the ION registry population. For the protocol specified secondary endpoint analysis including data pooled from the PERSEUS SV, PERSEUS WH and TE Prove patient populations please see the citations.	Annually, after the first year, through 2 years.

Name	Affiliation	Role
Louis A Cannon, MD	Northern Michigan Hospital	Principal Investigator
Carey D Kimmelstiel, MD	Tufts Medical Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
NEA Baptist Memorial Hospital		Jonesboro	Arkansas	72401	United States
St. Bernard's Medical Center

PubMed Identifier	Type	Citation	Retractions
	Result	Cannon L, Kimmelstiel CD, Kellett M, White A, Hill R, Grady T, Myers PR, Underwood P, Dawkins KD. One-year real-world outcomes following implantation of the ION paclitaxel-eluting platinum chromium coronary stent in routine clinical practice: Primary endpoint results of the ION U.S. post-approval registry [abstract]. J Am Coll Cardiol. 2013; 62 (18 SUPPL. 1): B58
	Result	Kimmelstiel CD, Cannon LA, Jobe RL, Stoler R, Pow T, Ganim R, Kayser R, Allocco DJ, Dawkins KD. Two-Year "Real-World" Outcomes Following Implantation of the ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent in Routine Clinical Practice: Results From the ION U.S. Post-Approval Registry. Presented at: The Transcatheter and Cardiovascular Therapeutics Annual Meeting 2014; Washington, D.C, USA. September 13 - 17, 2014.

ID	Title	Description
FG000	ION Registry	The ION Registry population consists of 1111 subjects that were enrolled and received a study stent.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Angina Pectoris	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG00070 events59 affected1,111 at risk
Angina Unstable	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG00031 events23 affected1,111 at risk
Acute Myocardial Infarction	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG00027 events27 affected1,111 at risk
Cardiac Congestive Failure	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG00026 events23 affected1,111 at risk
Coronary artery thrombosis	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG00018 events15 affected1,111 at risk
Myocardial Infarction	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG00017 events17 affected1,111 at risk
Atrial Fibriliation	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG00017 events14 affected1,111 at risk
Coronary artery disease	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG00014 events13 affected1,111 at risk
Cardiac arrest	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0007 events7 affected1,111 at risk
Acute Coronary System	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0005 events5 affected1,111 at risk
Cardiac failure	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0004 events4 affected1,111 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0004 events4 affected1,111 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0004 events4 affected1,111 at risk
Atrial flutter	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0004 events3 affected1,111 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0004 events3 affected1,111 at risk
Cardiogenic shock	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0004 events3 affected1,111 at risk
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0004 events3 affected1,111 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0004 events2 affected1,111 at risk
Cardiomyopathy	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0003 events3 affected1,111 at risk
Arrhythmia supraventricular	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected1,111 at risk
Atrioventricular block	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected1,111 at risk
Coronary artery dissection	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected1,111 at risk
Pericarditis	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected1,111 at risk
Sick sinus syndrome	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected1,111 at risk
Atrial tachycardia	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Atrioventricular block	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Bradycardia	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Cardiac tamponade	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Chronotropic incompetence	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Intracardiac thrombus	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Palpitations	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Pericardial effusion	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Sinus arrest	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Tachycardia	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Pneumonia	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG00022 events18 affected1,111 at risk
Urinary tract infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG00010 events10 affected1,111 at risk
Sepsis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0005 events5 affected1,111 at risk
Diverticulitis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0005 events4 affected1,111 at risk
Bronchitis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0003 events3 affected1,111 at risk
Cellulitis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0003 events3 affected1,111 at risk
Abscess	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected1,111 at risk
Appendicitis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected1,111 at risk
Gastroenteritis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected1,111 at risk
Arthritis bacterial	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Bacteraemia	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Gangrene	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Gastroenteritis viral	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Herpes zoster	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Infected skin ulcer	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Lobar pneumonia	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Meningitis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Osteomyelitis acute	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Periorbital abscess	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Peritonitis bacterial	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Pneumonia influenzal	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Pneumonia pneumococcal	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Postoperative wound infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Pyelonephritis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Septic shock	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Tooth infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Non-cardiac chest pain	General disorders	MedDRA (12.0)	Systematic Assessment	EG00046 events35 affected1,111 at risk
Chest pain	General disorders	MedDRA (12.0)	Systematic Assessment	EG0006 events6 affected1,111 at risk
Chest discomfort	General disorders	MedDRA (12.0)	Systematic Assessment	EG0003 events3 affected1,111 at risk
Pyrexia	General disorders	MedDRA (12.0)	Systematic Assessment	EG0003 events3 affected1,111 at risk
Asthenia	General disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Catheter site haematoma	General disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Hernia obstructive	General disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Sudden cardiac death	General disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG00012 events11 affected1,111 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0003 events3 affected1,111 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected1,111 at risk
Colonic polyp	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected1,111 at risk
Constipation	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected1,111 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected1,111 at risk
Retroperitoneal haemorrhage	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected1,111 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events1 affected1,111 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Ascites	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Barrett's oesophagus	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Enterovesical fistula	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Epiploic appendagitis	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Gastritis	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Gastrointestinal ulcer haemorrhage	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Gastroesophageal reflux disease	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Ileus	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Intestional perforation	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Intra-abdominal haemorrhage	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Pancreatitis chronic	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Retroperitoneal haematoma	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0008 events8 affected1,111 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0008 events6 affected1,111 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0004 events4 affected1,111 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0004 events4 affected1,111 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0004 events4 affected1,111 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected1,111 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected1,111 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected1,111 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Hypertension	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0006 events4 affected1,111 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0005 events4 affected1,111 at risk
Aortic stenosis	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected1,111 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected1,111 at risk
Femoral arterial stenosis	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected1,111 at risk
Intermittent claudication	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected1,111 at risk
Aortic aneurysm	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Arterial haemorrhage	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Haemorrhage	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Hypotension	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Iliac artery embolism	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Iliac artery occlusion	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Leriche syndrome	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Orthostatic hypotension	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Peripheral ischaemia	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Syncope	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0008 events8 affected1,111 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0006 events6 affected1,111 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected1,111 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected1,111 at risk
Ataxia	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Embolic stroke	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Hemiparesis	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Ischaemic stroke	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Migrane	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Presyncope	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (12.0)	Systematic Assessment	EG00017 events14 affected1,111 at risk
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected1,111 at risk
Heparin-induced thrombocytopenia	Blood and lymphatic system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0007 events7 affected1,111 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected1,111 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected1,111 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected1,111 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Hypervolaemia	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Post procedural myocardial infarction	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected1,111 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected1,111 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected1,111 at risk
Anaemia postoperative	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Arterial injury	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Device malfunction	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Postoperative ileus	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Renal injury	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Renal failure	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0004 events4 affected1,111 at risk
Renal failure acute	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0003 events3 affected1,111 at risk
Renal failure chronic	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0003 events3 affected1,111 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Nephropathy toxic	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Renal disorder	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Renal impairment	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Ureteric obstruction	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Breast cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Colon cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Endometrial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Lung adenocarcinoma stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Metastatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Parathyroid tumour benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Small cell lung cancer stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Vaginal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Biliary dyskinesia	Hepatobiliary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Hepatic artery stenosis	Hepatobiliary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Hepatic congestion	Hepatobiliary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Ischaemic hepatitis	Hepatobiliary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Cardiac stress test abnormal	Investigations	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected1,111 at risk
Blood creatinine increased	Investigations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Heart rate increased	Investigations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
International normalized ratio increased	Investigations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Intervertebral disc protusion	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Cataract	Eye disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected1,111 at risk
Conjunctival haemorrhage	Eye disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Vision blurred	Eye disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Skin plaque	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Bipolar I disorder	Psychiatric disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Deperession	Psychiatric disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Suicidal ideation	Psychiatric disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Arteriovenous malformation	Congenital, familial and genetic disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Congenital coronary artery malformation	Congenital, familial and genetic disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Vertigo	Ear and labyrinth disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Hyperthyroidism	Endocrine disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk
Cardiac pacemaker battery replacement	Surgical and medical procedures	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,111 at risk

ID	Term
D050197	Atherosclerosis
D003324	Coronary Artery Disease

ID	Term
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases