Study: NCT00305162

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 4374 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4374 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 4374 at risk

Adverse event: Arteriospasm coronary
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4374 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 4374 at risk

Adverse event: Atrioventricular block complete
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 4374 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 4374 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 4374 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 4374 at risk

Adverse event: Cardiac failure acute
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4374 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 4374 at risk

Adverse event: Cardiac tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4374 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 4374 at risk

Adverse event: Coronary artery dissection
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 4374 at risk

Adverse event: Coronary artery perforation
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 4374 at risk

Adverse event: Coronary artery thrombosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4374 at risk

Adverse event: Nodal rhythm
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4374 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4374 at risk

Adverse event: Sinus node dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 4374 at risk

Adverse event: Ventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4374 at risk

Adverse event: Ventricular asystole
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4374 at risk

Adverse event: Ventricular fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 12 affected / 4374 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 4374 at risk

Adverse event: Retinal artery occlusion
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 4374 at risk

Adverse event: Abdominal pain upper
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4374 at risk

Adverse event: Retroperitoneal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4374 at risk

Adverse event: Cardiac death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 4374 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 4374 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 4374 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 4374 at risk

Adverse event: Sudden cardiac death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 4374 at risk

Adverse event: Vessel puncture site haematoma
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 4374 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 4374 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 4374 at risk

Adverse event: Haematoma infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4374 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4374 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 4374 at risk

Adverse event: Thrombosis in device
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4374 at risk

Adverse event: Liver function test abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 4374 at risk

Adverse event: Gout
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4374 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4374 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4374 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4374 at risk

Adverse event: Presyncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 4374 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4374 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 4374 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 4374 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 11 affected / 4374 at risk

Adverse event: Acute pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 4374 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4374 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4374 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 4374 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 4374 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 4374 at risk

Adverse event: Angioedema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4374 at risk

Adverse event: Peripheral artery thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4374 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4374 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 7 affected / 4374 at risk

Adverse event: Orthostatic hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4374 at risk

Adverse event: Peripheral ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4374 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4374 at risk

Adverse event: Vascular pseudoaneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4374 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 178 affected / 4374 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 167 affected / 4374 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 112 affected / 4374 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 97 affected / 4374 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 93 affected / 4374 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 70 affected / 4374 at risk

Adverse event: Puncture site pain
Serious: no
Organ System: General disorders
Frequency: 67 affected / 4374 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 45 affected / 4374 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 42 affected / 4374 at risk

Adverse event: Ventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 37 affected / 4374 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 32 affected / 4374 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 32 affected / 4374 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 29 affected / 4374 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 27 affected / 4374 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Frequency: 20 affected / 4374 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 20 affected / 4374 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 4374 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 17 affected / 4374 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 4374 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 16 affected / 4374 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 4374 at risk

Adverse event: Haemolytic anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 4365 at risk

Adverse event: Blood loss anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 4365 at risk

Adverse event: Leukocytosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 4365 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 4365 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 4365 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4365 at risk

Adverse event: Arrhythmia supraventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4365 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 4365 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4365 at risk

Adverse event: Atrial tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4365 at risk

Adverse event: Atrioventricular block
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4365 at risk

Adverse event: Atrioventricular block complete
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 4365 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 4365 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 4365 at risk

Adverse event: Cardiac failure acute
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4365 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 4365 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 4365 at risk

Adverse event: Coronary artery dissection
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 4365 at risk

Adverse event: Coronary artery occlusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 4365 at risk

Adverse event: Coronary artery perforation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 4365 at risk

Adverse event: Vascular stent stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4365 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4365 at risk

Adverse event: Sinus arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 4365 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4365 at risk

Adverse event: Ventricular fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 4365 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 4365 at risk

Adverse event: Haematemesis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4365 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 4365 at risk

Adverse event: Chest discomfort
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 4365 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 9 affected / 4365 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 4365 at risk

Adverse event: Puncture site haemorrhage
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 4365 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 4365 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 4365 at risk

Adverse event: Gallbladder disorder
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 4365 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4365 at risk

Adverse event: Bronchitis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4365 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 4365 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4365 at risk

Adverse event: Fibula fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4365 at risk

Adverse event: Thrombosis in device
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 4365 at risk

Adverse event: Vascular procedure complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4365 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 4365 at risk

Adverse event: Myocardial necrosis marker increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 4365 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4365 at risk

Adverse event: Musculoskeletal pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4365 at risk

Adverse event: Diabetic neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4365 at risk

Adverse event: Presyncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 4365 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4365 at risk

Adverse event: Alcohol withdrawal syndrome
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 4365 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 4365 at risk

Adverse event: Renal artery stenosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 4365 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 4365 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 5 affected / 4365 at risk

Adverse event: Chronic kidney disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 4365 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4365 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4365 at risk

Adverse event: Pulmonary congestion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4365 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 4365 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 4365 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 4365 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 4365 at risk

Adverse event: Stent removal
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 4365 at risk

Adverse event: Peripheral artery thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4365 at risk

Adverse event: Artery dissection
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4365 at risk

Adverse event: Femoral artery dissection
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4365 at risk

Adverse event: Peripheral artery occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4365 at risk

Adverse event: Haemodynamic instability
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4365 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4365 at risk

Adverse event: Hypertensive emergency
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 4365 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 8 affected / 4365 at risk

Adverse event: Peripheral ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4365 at risk

Adverse event: Reperfusion injury
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4365 at risk

Adverse event: Shock haemorrhagic
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4365 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4365 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 163 affected / 4365 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 164 affected / 4365 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 145 affected / 4365 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 89 affected / 4365 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 97 affected / 4365 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 78 affected / 4365 at risk

Adverse event: Puncture site pain
Serious: no
Organ System: General disorders
Frequency: 52 affected / 4365 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 37 affected / 4365 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 4365 at risk

Adverse event: Ventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 35 affected / 4365 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 34 affected / 4365 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 24 affected / 4365 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 35 affected / 4365 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 18 affected / 4365 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Frequency: 34 affected / 4365 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 24 affected / 4365 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 26 affected / 4365 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 23 affected / 4365 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 21 affected / 4365 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 22 affected / 4365 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 4365 at risk