Study: NCT01120379

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 23 affected / 4852 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 229 affected / 4852 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 784 affected / 4852 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 218 affected / 4852 at risk

Adverse event: Aortic valve disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Aortic valve stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 22 affected / 4852 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 4852 at risk

Adverse event: Arteriosclerosis coronary artery
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 4852 at risk

Adverse event: Arteriospasm coronary
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 4852 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 110 affected / 4852 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 37 affected / 4852 at risk

Adverse event: Atrial tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Atrial thrombosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 4852 at risk

Adverse event: Atrioventricular block
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 4852 at risk

Adverse event: Atrioventricular block complete
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 4852 at risk

Adverse event: Atrioventricular block second degree
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 4852 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 34 affected / 4852 at risk

Adverse event: Bundle branch block left
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 38 affected / 4852 at risk

Adverse event: Cardiac disorder
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 4852 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 28 affected / 4852 at risk

Adverse event: Cardiac failure acute
Serious: yes
Organ System: Cardiac disorders
Frequency: 19 affected / 4852 at risk

Adverse event: Cardiac failure chronic
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 4852 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 183 affected / 4852 at risk

Adverse event: Cardiac perforation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Cardiac tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 4852 at risk

Adverse event: Cardiac valve disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 4852 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 20 affected / 4852 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 12 affected / 4852 at risk

Adverse event: Cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 18 affected / 4852 at risk

Adverse event: Cardiopulmonary failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Dilated cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 4852 at risk

Adverse event: Cor pulmonale chronic
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Coronary artery aneurysm
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 120 affected / 4852 at risk

Adverse event: Coronary artery dissection
Serious: yes
Organ System: Cardiac disorders
Frequency: 15 affected / 4852 at risk

Adverse event: Coronary artery occlusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 32 affected / 4852 at risk

Adverse event: Coronary artery perforation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Coronary artery stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 74 affected / 4852 at risk

Adverse event: Coronary artery thrombosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 4852 at risk

Adverse event: Coronary ostial stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 4852 at risk

Adverse event: Pulseless electrical activity
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 4852 at risk

Adverse event: Extrasystoles
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Hypertensive cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Cardiac ventricular thrombosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 4852 at risk

Adverse event: Ischaemic cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 16 affected / 4852 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 4852 at risk

Adverse event: Left ventricular hypertrophy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Low cardiac output syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Mitral valve calcification
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Mitral valve incompetence
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 4852 at risk

Adverse event: Mitral valve prolapse
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Mitral valve stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 57 affected / 4852 at risk

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 43 affected / 4852 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 4852 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 4852 at risk

Adverse event: Pericardial haemorrhage
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 4852 at risk

Adverse event: Pericarditis constrictive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Post procedural myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 4852 at risk

Adverse event: Right ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Right ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Sinus node dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 23 affected / 4852 at risk

Adverse event: Sinus arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 4852 at risk

Adverse event: Sinus arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 4852 at risk

Adverse event: Sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 4852 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 4852 at risk

Adverse event: Sudden cardiac death
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 4852 at risk

Adverse event: Supraventricular extrasystoles
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 4852 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 4852 at risk

Adverse event: Torsade de pointes
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Tricuspid valve incompetence
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 4852 at risk

Adverse event: Ventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 4852 at risk

Adverse event: Ventricular asystole
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 4852 at risk

Adverse event: Ventricular extrasystoles
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 4852 at risk

Adverse event: Ventricular fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 18 affected / 4852 at risk

Adverse event: Ventricular flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 40 affected / 4852 at risk

Adverse event: Accidental death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Adverse drug reaction
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 4852 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 15 affected / 4852 at risk

Adverse event: Catheter site haematoma
Serious: yes
Organ System: General disorders
Frequency: 21 affected / 4852 at risk

Adverse event: Catheter site haemorrhage
Serious: yes
Organ System: General disorders
Frequency: 9 affected / 4852 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Drug withdrawal syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Exercise tolerance decreased
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 4852 at risk

Adverse event: Gait disturbance
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 4852 at risk

Adverse event: Generalised oedema
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 4852 at risk

Adverse event: Hernia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Hernia obstructive
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Hypothermia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Impaired healing
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Implant site discharge
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Infusion site phlebitis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Malaise
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 4852 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 231 affected / 4852 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: General disorders
Frequency: 9 affected / 4852 at risk

Adverse event: Organ failure
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 11 affected / 4852 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 4852 at risk

Adverse event: Surgical failure
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Systemic inflammatory response syndrome
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 4852 at risk

Adverse event: Unevaluable event
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Allergy to metals
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Amyloidosis
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Contrast media reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Dermatitis allergic
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Drug hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 3 affected / 4852 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Anaemia postoperative
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 10 affected / 4852 at risk

Adverse event: Arteriovenous fistula site complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4852 at risk

Adverse event: Arteriovenous fistula thrombosis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4852 at risk

Adverse event: Arteriovenous graft thrombosis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 4852 at risk

Adverse event: Device malfunction
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 4852 at risk

Adverse event: Coronary artery reocclusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4852 at risk

Adverse event: Coronary artery restenosis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 12 affected / 4852 at risk

Adverse event: Coronary bypass thrombosis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4852 at risk

Adverse event: Device dislocation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4852 at risk

Adverse event: Device electrical finding
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 4852 at risk

Adverse event: Device lead damage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4852 at risk

Adverse event: Device malfunction
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 4852 at risk

Adverse event: Endotracheal intubation complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4852 at risk

Adverse event: Device malfunction
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4852 at risk

Adverse event: Vascular stent stenosis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 9 affected / 4852 at risk

Adverse event: Vascular stent stenosis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 160 affected / 4852 at risk

Adverse event: Incision site haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4852 at risk

Adverse event: Incisional hernia
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 4852 at risk

Adverse event: Joint dislocation postoperative
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4852 at risk

Adverse event: Lead dislodgement
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4852 at risk

Adverse event: Complication associated with device
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 4852 at risk

Adverse event: Procedural haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4852 at risk

Adverse event: Other injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Other injuries consists of all the preferred terms which were not in Administration site reactions and Procedural and device related injuries high level group terms (HLGT) category for the corresponding system organ class (SOC).
Frequency: 118 affected / 4852 at risk

Adverse event: Post procedural complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 4852 at risk

Adverse event: Post procedural haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 4852 at risk

Adverse event: Postoperative renal failure
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 4852 at risk

Adverse event: Procedural headache
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 4852 at risk

Adverse event: Procedural hypotension
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 10 affected / 4852 at risk

Adverse event: Procedural nausea
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4852 at risk

Adverse event: Procedural vomiting
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 4852 at risk

Adverse event: Reperfusion injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 4852 at risk

Adverse event: Seroma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4852 at risk

Adverse event: Device occlusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 4852 at risk

Adverse event: Stent-graft endoleak
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4852 at risk

Adverse event: Thrombosis in device
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 4852 at risk

Adverse event: Urinary retention postoperative
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 4852 at risk

Adverse event: Vascular graft complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4852 at risk

Adverse event: Vascular graft occlusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 15 affected / 4852 at risk

Adverse event: Weaning failure
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4852 at risk

Adverse event: Wound dehiscence
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 4852 at risk

Adverse event: Others/Miscellaneous
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 89 affected / 4852 at risk

Adverse event: Others/Miscellaneous
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 10 affected / 4852 at risk

Adverse event: Others/Miscellaneous
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 4852 at risk

Adverse event: Others/Miscellaneous
Serious: yes
Organ System: Endocrine disorders
Frequency: 5 affected / 4852 at risk

Adverse event: Others/Miscellaneous
Serious: yes
Organ System: Eye disorders
Frequency: 10 affected / 4852 at risk

Adverse event: Others/Miscellaneous
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 218 affected / 4852 at risk

Adverse event: Others/Miscellaneous
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 55 affected / 4852 at risk

Adverse event: Others/Miscellaneous
Serious: yes
Organ System: Infections and infestations
Frequency: 414 affected / 4852 at risk

Adverse event: Others/Miscellaneous
Serious: yes
Organ System: Investigations
Frequency: 76 affected / 4852 at risk

Adverse event: Others/Miscellaneous
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 106 affected / 4852 at risk

Adverse event: Others/Miscellaneous
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 181 affected / 4852 at risk

Adverse event: Others/Miscellaneous
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 161 affected / 4852 at risk

Adverse event: Others/Miscellaneous
Serious: yes
Organ System: Nervous system disorders
Frequency: 332 affected / 4852 at risk

Adverse event: Others/Miscellaneous
Serious: yes
Organ System: Psychiatric disorders
Frequency: 42 affected / 4852 at risk

Adverse event: Others/Miscellaneous
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 12 affected / 4852 at risk

Adverse event: Others/Miscellaneous
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 340 affected / 4852 at risk

Adverse event: Others/Miscellaneous
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 4852 at risk

Adverse event: Others/Miscellaneous
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 30 affected / 4852 at risk

Adverse event: Other renal and urinary disorders
Serious: yes
Organ System: Renal and urinary disorders
Notes: Other renal and urinary disorders consist of all the preferred terms which were not in Acute renal failure for the corresponding system organ class.
Frequency: 95 affected / 4852 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 68 affected / 4852 at risk

Adverse event: Accelerated hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 4852 at risk

Adverse event: Aortic aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 18 affected / 4852 at risk

Adverse event: Aortic aneurysm rupture
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 4852 at risk

Adverse event: Aortic dissection
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 4852 at risk

Adverse event: Aortic intramural haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Aortic stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 4852 at risk

Adverse event: Aortoenteric fistula
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Arterial occlusive disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Arterial restenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Arterial stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 4852 at risk

Adverse event: Peripheral artery thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 4852 at risk

Adverse event: Arteriosclerosis
Serious: yes
Organ System: Vascular disorders
Frequency: 19 affected / 4852 at risk

Adverse event: Arteriovenous fistula
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 4852 at risk

Adverse event: Arteriovenous malformation
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Carotid arteriosclerosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Carotid artery disease
Serious: yes
Organ System: Vascular disorders
Frequency: 7 affected / 4852 at risk

Adverse event: Carotid artery occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 4852 at risk

Adverse event: Carotid artery stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 46 affected / 4852 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 4852 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 24 affected / 4852 at risk

Adverse event: Diverticulitis intestinal haemorrhagic
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Diverticulum intestinal haemorrhagic
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 4852 at risk

Adverse event: Duodenal ulcer haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 4852 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Vascular disorders
Frequency: 9 affected / 4852 at risk

Adverse event: Peripheral artery stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 8 affected / 4852 at risk

Adverse event: Peripheral artery occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 7 affected / 4852 at risk

Adverse event: Gastric haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 4852 at risk

Adverse event: Gastric ulcer haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 7 affected / 4852 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 70 affected / 4852 at risk

Adverse event: Gastrointestinal ulcer haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 4852 at risk

Adverse event: Haemarthrosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Haematemesis
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 4852 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 4852 at risk

Adverse event: Haemoptysis
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 4852 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Vascular disorders
Frequency: 8 affected / 4852 at risk

Adverse event: Haemorrhagic erosive gastritis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 4852 at risk

Adverse event: Haemorrhagic stroke
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 4852 at risk

Adverse event: Hepatic haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 24 affected / 4852 at risk

Adverse event: Hypertensive crisis
Serious: yes
Organ System: Vascular disorders
Frequency: 7 affected / 4852 at risk

Adverse event: Hypertensive emergency
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 4852 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 33 affected / 4852 at risk

Adverse event: Hypovolaemic shock
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Iliac artery occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 4852 at risk

Adverse event: Iliac artery stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 4852 at risk

Adverse event: Intermittent claudication
Serious: yes
Organ System: Vascular disorders
Frequency: 23 affected / 4852 at risk

Adverse event: Ischaemic limb pain
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Labile blood pressure
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Lower gastrointestinal haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 15 affected / 4852 at risk

Adverse event: Mallory-Weiss syndrome
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Mesenteric artery stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 4852 at risk

Adverse event: Mesenteric vascular occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Oesophageal haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Oesophageal varices haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 4852 at risk

Adverse event: Procedural haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 4852 at risk

Adverse event: Orthostatic hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 12 affected / 4852 at risk

Adverse event: Pelvic haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Peptic ulcer haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Peripheral arterial occlusive disease
Serious: yes
Organ System: Vascular disorders
Frequency: 10 affected / 4852 at risk

Adverse event: Peripheral artery aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 4852 at risk

Adverse event: Peripheral ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 10 affected / 4852 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 16 affected / 4852 at risk

Adverse event: Petechiae
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Pharyngeal haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Portal vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Post procedural haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Pulmonary artery thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 15 affected / 4852 at risk

Adverse event: Pulmonary hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 4852 at risk

Adverse event: Renal artery occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Renal artery stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 11 affected / 4852 at risk

Adverse event: Renal hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Retinal vascular occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Retroperitoneal haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 4852 at risk

Adverse event: Retroperitoneal haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 15 affected / 4852 at risk

Adverse event: Skin ulcer
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 4852 at risk

Adverse event: Subarachnoid haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 4852 at risk

Adverse event: Subclavian artery stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 4852 at risk

Adverse event: Subclavian steal syndrome
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 13 affected / 4852 at risk

Adverse event: Subdural haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Superior vena caval occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 4852 at risk

Adverse event: Ulcer haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 4852 at risk

Adverse event: Upper gastrointestinal haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 15 affected / 4852 at risk

Adverse event: Vascular insufficiency
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Vascular occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Vascular pseudoaneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 21 affected / 4852 at risk

Adverse event: Vessel perforation
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Wound haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4852 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Frequency: 644 affected / 4852 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 308 affected / 4852 at risk