Study: NCT01205776

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 18 affected / 948 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 31 affected / 948 at risk

Adverse event: Coagulopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 948 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 948 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 24 affected / 948 at risk

Adverse event: Other
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 948 at risk

Adverse event: Respiratory tract haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 948 at risk

Adverse event: Retroperitoneal haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 948 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 948 at risk

Adverse event: Abrupt closure
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 948 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 21 affected / 948 at risk

Adverse event: Angina pectoris (includes atypical angina and cardiac chest pain)
Serious: yes
Organ System: Cardiac disorders
Frequency: 100 affected / 948 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 31 affected / 948 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 948 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 26 affected / 948 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 948 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 948 at risk

Adverse event: Cardiac : Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 53 affected / 948 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 948 at risk

Adverse event: Myocardial necrosis marker increased
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 948 at risk

Adverse event: Cardiac functional test abnormal
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 948 at risk

Adverse event: Cardiac tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 948 at risk

Adverse event: Cardiac valve disorder/disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 948 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 948 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 948 at risk

Adverse event: Cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 948 at risk

Adverse event: Conduction disorder (including AV block, BBB)
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 948 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 31 affected / 948 at risk

Adverse event: Coronary artery dissection
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 948 at risk

Adverse event: Coronary artery graft occlusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 948 at risk

Adverse event: Coronary artery in-stent restenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 26 affected / 948 at risk

Adverse event: Coronary artery occlusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 948 at risk

Adverse event: Coronary artery perforation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 948 at risk

Adverse event: Coronary artery reocclusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 948 at risk

Adverse event: Coronary artery stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 19 affected / 948 at risk

Adverse event: Vascular stent thrombosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 948 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 948 at risk

Adverse event: Hypertensive crisis
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 948 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 948 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 73 affected / 948 at risk

Adverse event: No-reflow phenomenon/slow flow
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 948 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 948 at risk

Adverse event: Plaque shift (tissue breakdown associated with device)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 948 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 948 at risk

Adverse event: Ventricular fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 948 at risk

Adverse event: Ventricular tachycardia (sustained)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 948 at risk

Adverse event: electrocardiogram (ECG) abnormal
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 948 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Endocrine disorders
Frequency: 5 affected / 948 at risk

Adverse event: Other : Endocrine disorder
Serious: yes
Organ System: Endocrine disorders
Frequency: 4 affected / 948 at risk

Adverse event: Abdominal discomfort
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 948 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 948 at risk

Adverse event: Colonic/intestinal polyp
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 948 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 948 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 948 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 948 at risk

Adverse event: Gastroesophageal reflux diseases
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 948 at risk

Adverse event: Gastrointestinal ulcer/peptic ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 948 at risk

Adverse event: Hepatobiliary disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 948 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 948 at risk

Adverse event: Other : Gastrointestinal disorder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 948 at risk

Adverse event: Pancreatic disorder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 948 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 948 at risk

Adverse event: Cataract
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 948 at risk

Adverse event: Chest pain (non-cardiac or non-specific)
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 948 at risk

Adverse event: Dehydration
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 948 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 948 at risk

Adverse event: Eye disorders
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 948 at risk

Adverse event: Fall
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 948 at risk

Adverse event: Fatigue/Weakness
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 948 at risk

Adverse event: Fever/Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 948 at risk

Adverse event: Injury
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 948 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Frequency: 11 affected / 948 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 948 at risk

Adverse event: Contrast media allergy/reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 948 at risk

Adverse event: Hypersensitivity/allergic reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 948 at risk

Adverse event: Bone and joint infections
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 948 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 948 at risk

Adverse event: Deep sternal wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 948 at risk

Adverse event: Flu/influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 948 at risk

Adverse event: Gastrointestinal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 948 at risk

Adverse event: Genitourinary infection
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 948 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 948 at risk

Adverse event: Other : Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 25 affected / 948 at risk

Adverse event: Skin and subcutaneous infection
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 948 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 948 at risk

Adverse event: Vein harvest site infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 948 at risk

Adverse event: Catheter site haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Percutaneous coronary intervention (PCI) complications: access site complications
Frequency: 2 affected / 948 at risk

Adverse event: Other : Percutaneous coronary intervention (PCI) complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Percutaneous coronary intervention (PCI) complications: access site complications
Frequency: 4 affected / 948 at risk

Adverse event: Blood creatinine increased
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 948 at risk

Adverse event: Elevated cardiac enzymes
Serious: yes
Organ System: Investigations
Frequency: 8 affected / 948 at risk

Adverse event: Haemoglobin decreased
Serious: yes
Organ System: Investigations
Frequency: 7 affected / 948 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 948 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 948 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 948 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 948 at risk

Adverse event: Other
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 948 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 948 at risk

Adverse event: Backpain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 948 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 948 at risk

Adverse event: Joint or tendon disease/disorder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 948 at risk

Adverse event: Musculoskeletal pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 948 at risk

Adverse event: Other : Musculoskeletal disorder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 948 at risk

Adverse event: Spinal disorder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 948 at risk

Adverse event: Neoplasm/cancer : Blood or lymphatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 948 at risk

Adverse event: Neoplasm/cancer : Gastrointestinal
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 13 affected / 948 at risk

Adverse event: Neoplasm/cancer : Musculoskeletal
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 948 at risk

Adverse event: Neoplasm/cancer : Nervous system
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 948 at risk

Adverse event: Neoplasm/cancer : Reproductive system
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 948 at risk

Adverse event: Neoplasm/cancer : Respiratory
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 13 affected / 948 at risk

Adverse event: Neoplasm/cancer : Skin or subcutaneous
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 948 at risk

Adverse event: Neoplasm/cancer : Urinary
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 7 affected / 948 at risk

Adverse event: Other :Neoplasm/cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 13 affected / 948 at risk

Adverse event: Cerebrovascular accident (CVA)
Serious: yes
Organ System: Nervous system disorders
Frequency: 27 affected / 948 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 948 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 948 at risk

Adverse event: Other : Neurological/psychiatric disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 9 affected / 948 at risk

Adverse event: Seizure/convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 948 at risk

Adverse event: Syncope/fainting/loss of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 948 at risk

Adverse event: Transient ischemic attack (TIA)
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 948 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 948 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 948 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 948 at risk

Adverse event: Mental status change
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 948 at risk

Adverse event: Psychiatric disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 948 at risk

Adverse event: Benign prostatic hyperplasia
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 948 at risk

Adverse event: Other : Renal and urinary disorder
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 14 affected / 948 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 17 affected / 948 at risk

Adverse event: Renal insufficiency/impairment
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 7 affected / 948 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 948 at risk

Adverse event: Urinary stone/calculus
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 948 at risk

Adverse event: Urinary tract obstruction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 948 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 948 at risk

Adverse event: COPD (chronic obstructive pulmonary disease)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 948 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 948 at risk

Adverse event: Dyspnea/shortness of breath
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 948 at risk

Adverse event: Other : Respiratory disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 19 affected / 948 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 948 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 948 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 948 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 948 at risk

Adverse event: Aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 948 at risk

Adverse event: Intermittent claudication
Serious: yes
Organ System: Vascular disorders
Frequency: 8 affected / 948 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 948 at risk

Adverse event: Dissection
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 948 at risk

Adverse event: Other : Peripheral vascular disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 948 at risk

Adverse event: Peripheral artery disease/peripheral venous disease
Serious: yes
Organ System: Vascular disorders
Frequency: 13 affected / 948 at risk

Adverse event: Vascular pseudoaneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 948 at risk

Adverse event: Stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 948 at risk

Adverse event: Thrombosis (non stent/non-coronary)
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 948 at risk

Adverse event: Vascular occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 948 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 42 affected / 948 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 75 affected / 948 at risk

Adverse event: Coagulopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 948 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 948 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 36 affected / 948 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 948 at risk

Adverse event: Other
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 47 affected / 948 at risk

Adverse event: Respiratory tract haemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 948 at risk

Adverse event: Retroperitoneal haemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 948 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 948 at risk

Adverse event: Abrupt closure
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 948 at risk

Adverse event: Acute coronary syndrome
Serious: no
Organ System: Cardiac disorders
Frequency: 21 affected / 948 at risk

Adverse event: Angina pectoris (includes atypical angina and cardiac chest pain)
Serious: no
Organ System: Cardiac disorders
Frequency: 205 affected / 948 at risk

Adverse event: Angina unstable
Serious: no
Organ System: Cardiac disorders
Frequency: 42 affected / 948 at risk

Adverse event: Cardiac arrest
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 948 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 54 affected / 948 at risk

Adverse event: Atrial flutter
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 948 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 24 affected / 948 at risk

Adverse event: Cardiac arrest
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 948 at risk

Adverse event: Myocardial necrosis marker increased
Serious: no
Organ System: Cardiac disorders
Frequency: 16 affected / 948 at risk

Adverse event: Cardiac functional test abnormal
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 948 at risk

Adverse event: Cardiac tamponade
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 948 at risk

Adverse event: Cardiac valve disorder/disease
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 948 at risk

Adverse event: Cardio-respiratory arrest
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 948 at risk

Adverse event: Cardiogenic shock
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 948 at risk

Adverse event: Cardiomyopathy
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 948 at risk

Adverse event: Conduction disorder (including atrioventricular block (AV block, bundle branch block(BBB))
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 948 at risk

Adverse event: Cardiac failure congestive
Serious: no
Organ System: Cardiac disorders
Frequency: 39 affected / 948 at risk

Adverse event: Coronary artery dissection
Serious: no
Organ System: Cardiac disorders
Frequency: 23 affected / 948 at risk

Adverse event: Coronary artery graft occlusion
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 948 at risk

Adverse event: Coronary artery in-stent restenosis
Serious: no
Organ System: Cardiac disorders
Frequency: 27 affected / 948 at risk

Adverse event: Coronary artery occlusion
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 948 at risk

Adverse event: Coronary artery perforation
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 948 at risk

Adverse event: Coronary artery reocclusion
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 948 at risk

Adverse event: Coronary artery stenosis
Serious: no
Organ System: Cardiac disorders
Frequency: 20 affected / 948 at risk

Adverse event: Vascular stent thrombosis
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 948 at risk

Adverse event: Electrocardiogram (ECG) abnormal
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 948 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 31 affected / 948 at risk

Adverse event: Hypertensive crisis
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 948 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 32 affected / 948 at risk

Adverse event: Myocardial infarction
Serious: no
Organ System: Cardiac disorders
Frequency: 78 affected / 948 at risk

Adverse event: No-reflow phenomenon/slow flow
Serious: no
Organ System: Cardiac disorders
Frequency: 9 affected / 948 at risk

Adverse event: Other
Serious: no
Organ System: Cardiac disorders
Frequency: 103 affected / 948 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 12 affected / 948 at risk

Adverse event: Pericardial effusion
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 948 at risk

Adverse event: Plaque shift (tissue breakdown associated with device)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 948 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 12 affected / 948 at risk

Adverse event: Ventricular fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 948 at risk

Adverse event: Ventricular tachycardia (sustained)
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 948 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Endocrine disorders
Frequency: 21 affected / 948 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 6 affected / 948 at risk

Adverse event: Other
Serious: no
Organ System: Endocrine disorders
Frequency: 9 affected / 948 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 948 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 948 at risk

Adverse event: Colonic/intestinal polyp
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 948 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 948 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 948 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 948 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 948 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 948 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 948 at risk

Adverse event: Gastrointestinal ulcer/peptic ulcer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 948 at risk

Adverse event: Gastrooesophageal reflux diseases
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 948 at risk

Adverse event: Hepatobiliary disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 948 at risk

Adverse event: Intestinal obstruction
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 948 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 948 at risk

Adverse event: Other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 69 affected / 948 at risk

Adverse event: Pancreatic disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 948 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 948 at risk

Adverse event: Cataract
Serious: no
Organ System: General disorders
Frequency: 4 affected / 948 at risk

Adverse event: Chest pain (non-cardiac or non-specific)
Serious: no
Organ System: General disorders
Frequency: 30 affected / 948 at risk

Adverse event: Dehydration
Serious: no
Organ System: General disorders
Frequency: 3 affected / 948 at risk

Adverse event: Ear disorders
Serious: no
Organ System: General disorders
Frequency: 3 affected / 948 at risk

Adverse event: Ecchymosis
Serious: no
Organ System: General disorders
Frequency: 4 affected / 948 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 15 affected / 948 at risk

Adverse event: Eye disorders
Serious: no
Organ System: General disorders
Frequency: 3 affected / 948 at risk

Adverse event: Fall
Serious: no
Organ System: General disorders
Frequency: 10 affected / 948 at risk

Adverse event: Fatigue/Weakness
Serious: no
Organ System: General disorders
Frequency: 20 affected / 948 at risk

Adverse event: Fever/Pyrexia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 948 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 6 affected / 948 at risk

Adverse event: Injury
Serious: no
Organ System: General disorders
Frequency: 4 affected / 948 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 53 affected / 948 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 6 affected / 948 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Frequency: 5 affected / 948 at risk

Adverse event: Contrast media allergy/reaction
Serious: no
Organ System: Immune system disorders
Frequency: 4 affected / 948 at risk

Adverse event: Drug hypersensitivity/drug allergy
Serious: no
Organ System: Immune system disorders
Frequency: 19 affected / 948 at risk

Adverse event: Hypersensitivity/allergic reaction
Serious: no
Organ System: Immune system disorders
Frequency: 11 affected / 948 at risk

Adverse event: Other
Serious: no
Organ System: Immune system disorders
Frequency: 8 affected / 948 at risk

Adverse event: Bone and joint infections
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 948 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 948 at risk

Adverse event: Deep sternal wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 948 at risk

Adverse event: Flu/influenza
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 948 at risk

Adverse event: Gastrointestinal infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 948 at risk

Adverse event: Genitourinary infection
Serious: no
Organ System: Infections and infestations
Frequency: 25 affected / 948 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 28 affected / 948 at risk

Adverse event: Other
Serious: no
Organ System: Infections and infestations
Frequency: 43 affected / 948 at risk

Adverse event: Skin and subcutaneous infection
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 948 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 26 affected / 948 at risk

Adverse event: Vein harvest site infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 948 at risk

Adverse event: Catheter site haematoma
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Percutaneous coronary intervention (PCI) complications: access site complications
Frequency: 24 affected / 948 at risk

Adverse event: Catheter site pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Percutaneous coronary intervention (PCI) complications: access site complications
Frequency: 3 affected / 948 at risk

Adverse event: Catheter site swelling
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Percutaneous coronary intervention (PCI) complications: access site complications
Frequency: 1 affected / 948 at risk

Adverse event: Cathether site bleeding
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Percutaneous coronary intervention (PCI) complications: access site complications
Frequency: 4 affected / 948 at risk

Adverse event: Other
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Percutaneous coronary intervention (PCI) complications: access site complications
Frequency: 12 affected / 948 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 12 affected / 948 at risk

Adverse event: Elevated cardiac enzymes
Serious: no
Organ System: Investigations
Frequency: 44 affected / 948 at risk

Adverse event: Haematocrit decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 948 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 17 affected / 948 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Investigations
Frequency: 3 affected / 948 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Investigations
Frequency: 7 affected / 948 at risk

Adverse event: Hyperlipidaemia/hypercholesterolemia
Serious: no
Organ System: Investigations
Frequency: 5 affected / 948 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 948 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Investigations
Frequency: 9 affected / 948 at risk

Adverse event: Liver function test abnormal
Serious: no
Organ System: Investigations
Frequency: 8 affected / 948 at risk

Adverse event: Other
Serious: no
Organ System: Investigations
Frequency: 14 affected / 948 at risk

Adverse event: Other abnormal blood test
Serious: no
Organ System: Investigations
Frequency: 4 affected / 948 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 20 affected / 948 at risk

Adverse event: Backpain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 24 affected / 948 at risk

Adverse event: Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 22 affected / 948 at risk

Adverse event: Joint or tendon disease/disorder
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 21 affected / 948 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 948 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 49 affected / 948 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 18 affected / 948 at risk

Adverse event: Other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 69 affected / 948 at risk

Adverse event: Spinal disorder
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 948 at risk

Adverse event: Neoplasm/cancer : Blood or lymphatic
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 5 affected / 948 at risk

Adverse event: Neoplasm/cancer : Gastrointestinal
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 13 affected / 948 at risk

Adverse event: Neoplasm/cancer : Musculoskeletal
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 948 at risk

Adverse event: Neoplasm/cancer : Nervous system
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 948 at risk

Adverse event: Neoplasm/cancer : Other
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 19 affected / 948 at risk

Adverse event: Neoplasm/cancer : Reproductive system
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 948 at risk

Adverse event: Neoplasm/cancer : Respiratory
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 13 affected / 948 at risk

Adverse event: Neoplasm/cancer : Skin or subcutaneous
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 13 affected / 948 at risk

Adverse event: Neoplasm/cancer : Urinary
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 8 affected / 948 at risk

Adverse event: Cerebrovascular accident (CVA)
Serious: no
Organ System: Nervous system disorders
Frequency: 29 affected / 948 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 948 at risk

Adverse event: Encephalopathy
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 948 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 948 at risk

Adverse event: Other : Neurological/psychiatric disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 28 affected / 948 at risk

Adverse event: Seizure/convulsion
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 948 at risk

Adverse event: Syncope/fainting/loss of consciousness
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 948 at risk

Adverse event: Transient ischemic attack (TIA)
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 948 at risk

Adverse event: Vertigo
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 948 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 948 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 948 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 948 at risk

Adverse event: Dementia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 948 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 948 at risk

Adverse event: Mental status change (including coma)
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 948 at risk

Adverse event: Psychiatric disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 948 at risk

Adverse event: Benign prostatic hyperplasia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 10 affected / 948 at risk

Adverse event: Incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 948 at risk

Adverse event: Nephrolithiasis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 948 at risk

Adverse event: Other
Serious: no
Organ System: Renal and urinary disorders
Frequency: 32 affected / 948 at risk

Adverse event: Renal artery stenosis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 948 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 21 affected / 948 at risk

Adverse event: Renal insufficiency/impairment
Serious: no
Organ System: Renal and urinary disorders
Frequency: 20 affected / 948 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 8 affected / 948 at risk

Adverse event: Urinary stone/calculus
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 948 at risk

Adverse event: Urinary tract obstruction
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 948 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 948 at risk

Adverse event: COPD (chronic obstructive pulmonary disease)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 23 affected / 948 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 948 at risk

Adverse event: Dyspnea/shortness of breath
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 58 affected / 948 at risk

Adverse event: Other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 51 affected / 948 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 948 at risk

Adverse event: Pneumonitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 948 at risk

Adverse event: Pulmonary embolism
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 948 at risk

Adverse event: Pulmonary hypertension
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 948 at risk

Adverse event: Respiratory failure
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 948 at risk

Adverse event: Aneurysm
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 948 at risk

Adverse event: Intermittent claudication
Serious: no
Organ System: Vascular disorders
Frequency: 12 affected / 948 at risk

Adverse event: Deep vein thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 948 at risk

Adverse event: Other
Serious: no
Organ System: Vascular disorders
Frequency: 14 affected / 948 at risk

Adverse event: Peripheral artery disease/peripheral venous disease
Serious: no
Organ System: Vascular disorders
Frequency: 26 affected / 948 at risk

Adverse event: Peripheral nerve lesion/injury
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 948 at risk

Adverse event: Vascular pseudoaneurysm
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 948 at risk

Adverse event: Stenosis
Serious: no
Organ System: Vascular disorders
Frequency: 17 affected / 948 at risk

Adverse event: Thrombophlebitis
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 948 at risk

Adverse event: Thrombosis (non stent/non-coronary)
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 948 at risk

Adverse event: Vascular occlusion
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 948 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 957 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 40 affected / 957 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 957 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 957 at risk

Adverse event: Other
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 957 at risk

Adverse event: Respiratory tract haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 957 at risk

Adverse event: Retroperitoneal haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 957 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 957 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 13 affected / 957 at risk

Adverse event: Angina pectoris (includes atypical angina and cardiac chest pain)
Serious: yes
Organ System: Cardiac disorders
Frequency: 54 affected / 957 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 17 affected / 957 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 957 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 36 affected / 957 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 957 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 957 at risk

Adverse event: Cardiac : Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 36 affected / 957 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 957 at risk

Adverse event: Myocardial necrosis marker increased
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 957 at risk

Adverse event: Cardiac functional test abnormal
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 957 at risk

Adverse event: Cardiac tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 957 at risk

Adverse event: Cardiac valve disorder/disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 957 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 957 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 957 at risk

Adverse event: Cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 957 at risk

Adverse event: Conduction disorder (including AV block, BBB)
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 957 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 37 affected / 957 at risk

Adverse event: Coronary arteriospasm
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 957 at risk

Adverse event: Coronary artery graft occlusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 30 affected / 957 at risk

Adverse event: Coronary artery in-stent restenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 957 at risk

Adverse event: Coronary artery occlusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 957 at risk

Adverse event: Coronary artery reocclusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 957 at risk

Adverse event: Coronary artery stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 957 at risk

Adverse event: Vascular stent thrombosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 957 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 957 at risk

Adverse event: Hypertensive crisis
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 957 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 957 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 47 affected / 957 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 957 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 957 at risk

Adverse event: Sinus node dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 957 at risk

Adverse event: Ventricular fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 957 at risk

Adverse event: Ventricular tachycardia (sustained)
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 957 at risk

Adverse event: electrocardiogram (ECG) abnormal
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 957 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 957 at risk

Adverse event: Hyperthyroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 957 at risk

Adverse event: Hypothyroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 957 at risk

Adverse event: Other : Endocrine disorder
Serious: yes
Organ System: Endocrine disorders
Frequency: 4 affected / 957 at risk

Adverse event: Abdominal discomfort
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 957 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 957 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 957 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 957 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 957 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 957 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 957 at risk

Adverse event: Gastroesophageal reflux diseases
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 957 at risk

Adverse event: Gastrointestinal ulcer/peptic ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 957 at risk

Adverse event: Hepatobiliary disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 957 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 957 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 957 at risk

Adverse event: Other : Gastrointestinal disorder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 957 at risk

Adverse event: Pancreatic disorder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 957 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 957 at risk

Adverse event: Accidents
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 957 at risk

Adverse event: Cataract
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 957 at risk

Adverse event: Chest pain (non-cardiac or non-specific)
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 957 at risk

Adverse event: Dehydration
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 957 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 957 at risk

Adverse event: Eye disorders
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 957 at risk

Adverse event: Fatigue/Weakness
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 957 at risk

Adverse event: Fever/Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 957 at risk

Adverse event: Headache
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 957 at risk

Adverse event: Injury
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 957 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Frequency: 15 affected / 957 at risk

Adverse event: Other shock
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 957 at risk

Adverse event: Allergic conditions : Other
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 957 at risk

Adverse event: Drug hypersensitivity/drug allergy
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 957 at risk

Adverse event: Hypersensitivity/allergic reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 3 affected / 957 at risk

Adverse event: Bone and joint infections
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 957 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 957 at risk

Adverse event: Deep sternal wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 14 affected / 957 at risk

Adverse event: Gastrointestinal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 957 at risk

Adverse event: Genitourinary infection
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 957 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 16 affected / 957 at risk

Adverse event: Other : Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 26 affected / 957 at risk

Adverse event: Skin and subcutaneous infection
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 957 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 957 at risk

Adverse event: Vein harvest site infection
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 957 at risk

Adverse event: Other : Percutaneous coronary intervention (PCI) complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Percutaneous coronary intervention (PCI) complications: access site complications
Frequency: 2 affected / 957 at risk

Adverse event: Blood creatinine increased
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 957 at risk

Adverse event: Elevated cardiac enzymes
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 957 at risk

Adverse event: Haemoglobin decreased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 957 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 957 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 957 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 957 at risk

Adverse event: Liver function test abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 957 at risk

Adverse event: Other
Serious: yes
Organ System: Investigations
Frequency: 5 affected / 957 at risk

Adverse event: Other abnormal blood test
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 957 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 957 at risk

Adverse event: Backpain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 957 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 21 affected / 957 at risk

Adverse event: Joint or tendon disease/disorder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 957 at risk

Adverse event: Musculoskeletal pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 16 affected / 957 at risk

Adverse event: Myalgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 957 at risk

Adverse event: Other : Musculoskeletal disorder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 957 at risk

Adverse event: Spinal disorder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 957 at risk

Adverse event: Neoplasm/cancer : Blood or lymphatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 957 at risk

Adverse event: Neoplasm/cancer : Gastrointestinal
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 957 at risk

Adverse event: Neoplasm/cancer : Musculoskeletal
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 957 at risk

Adverse event: Neoplasm/cancer : Nervous system
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 957 at risk

Adverse event: Neoplasm/cancer : Reproductive system
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 957 at risk

Adverse event: Neoplasm/cancer : Respiratory
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 6 affected / 957 at risk

Adverse event: Neoplasm/cancer : Skin or subcutaneous
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 957 at risk

Adverse event: Neoplasm/cancer : Urinary
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 7 affected / 957 at risk

Adverse event: Other :Neoplasm/cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 14 affected / 957 at risk

Adverse event: Cerebrovascular accident (CVA)
Serious: yes
Organ System: Nervous system disorders
Frequency: 36 affected / 957 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 957 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 957 at risk

Adverse event: Other : Neurological/psychiatric disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 13 affected / 957 at risk

Adverse event: Seizure/convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 957 at risk

Adverse event: Syncope/fainting/loss of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 957 at risk

Adverse event: Transient ischemic attack (TIA)
Serious: yes
Organ System: Nervous system disorders
Frequency: 11 affected / 957 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 957 at risk

Adverse event: Agitation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 957 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 957 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 957 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 957 at risk

Adverse event: Psychiatric disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 957 at risk

Adverse event: Benign prostatic hyperplasia
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 957 at risk

Adverse event: Incontinence
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 957 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 957 at risk

Adverse event: Other : Renal and urinary disorder
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 10 affected / 957 at risk

Adverse event: Renal artery stenosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 957 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 14 affected / 957 at risk

Adverse event: Renal insufficiency/impairment
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 17 affected / 957 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 957 at risk

Adverse event: Urinary stone/calculus
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 957 at risk

Adverse event: COPD (chronic obstructive pulmonary disease)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 957 at risk

Adverse event: Dyspnea/shortness of breath
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 957 at risk

Adverse event: Other : Respiratory disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 30 affected / 957 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 957 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 957 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 957 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 27 affected / 957 at risk

Adverse event: Aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 957 at risk

Adverse event: Intermittent claudication
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 957 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 957 at risk

Adverse event: Dissection
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 957 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 957 at risk

Adverse event: Other : Peripheral vascular disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 957 at risk

Adverse event: Peripheral artery disease/peripheral venous disease
Serious: yes
Organ System: Vascular disorders
Frequency: 19 affected / 957 at risk

Adverse event: Peripheral nerve lesion/injury (including peripheral neuropathy)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 957 at risk

Adverse event: Vascular pseudoaneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 957 at risk

Adverse event: Stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 10 affected / 957 at risk

Adverse event: Thrombosis (non stent/non-coronary)
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 957 at risk

Adverse event: Vascular occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 957 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 83 affected / 957 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 121 affected / 957 at risk

Adverse event: Coagulopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 957 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 957 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 957 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 957 at risk

Adverse event: Other
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 33 affected / 957 at risk

Adverse event: Respiratory tract haemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 957 at risk

Adverse event: Retroperitoneal haemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 957 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 16 affected / 957 at risk

Adverse event: Acute coronary syndrome
Serious: no
Organ System: Cardiac disorders
Frequency: 14 affected / 957 at risk

Adverse event: Angina pectoris (includes atypical angina and cardiac chest pain)
Serious: no
Organ System: Cardiac disorders
Frequency: 124 affected / 957 at risk

Adverse event: Angina unstable
Serious: no
Organ System: Cardiac disorders
Frequency: 22 affected / 957 at risk

Adverse event: Cardiac arrest
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 957 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 201 affected / 957 at risk

Adverse event: Atrial flutter
Serious: no
Organ System: Cardiac disorders
Frequency: 17 affected / 957 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 25 affected / 957 at risk

Adverse event: Cardiac arrest
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 957 at risk

Adverse event: Myocardial necrosis marker increased
Serious: no
Organ System: Cardiac disorders
Frequency: 18 affected / 957 at risk

Adverse event: Cardiac functional test abnormal
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 957 at risk

Adverse event: Cardiac tamponade
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 957 at risk

Adverse event: Cardiac valve disorder/disease
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 957 at risk

Adverse event: Cardio-respiratory arrest
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 957 at risk

Adverse event: Cardiogenic shock
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 957 at risk

Adverse event: Cardiomyopathy
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 957 at risk

Adverse event: Conduction disorder (including atrioventricular block (AV block, bundle branch block(BBB))
Serious: no
Organ System: Cardiac disorders
Frequency: 16 affected / 957 at risk

Adverse event: Cardiac failure congestive
Serious: no
Organ System: Cardiac disorders
Frequency: 50 affected / 957 at risk

Adverse event: Coronary arteriospasm
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 957 at risk

Adverse event: Coronary artery dissection
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 957 at risk

Adverse event: Coronary artery graft occlusion
Serious: no
Organ System: Cardiac disorders
Frequency: 34 affected / 957 at risk

Adverse event: Coronary artery in-stent restenosis
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 957 at risk

Adverse event: Coronary artery occlusion
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 957 at risk

Adverse event: Coronary artery perforation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 957 at risk

Adverse event: Coronary artery reocclusion
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 957 at risk

Adverse event: Coronary artery stenosis
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 957 at risk

Adverse event: Vascular stent thrombosis
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 957 at risk

Adverse event: Electrocardiogram (ECG) abnormal
Serious: no
Organ System: Cardiac disorders
Frequency: 14 affected / 957 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 42 affected / 957 at risk

Adverse event: Hypertensive crisis
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 957 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 23 affected / 957 at risk

Adverse event: Myocardial infarction
Serious: no
Organ System: Cardiac disorders
Frequency: 58 affected / 957 at risk

Adverse event: Other
Serious: no
Organ System: Cardiac disorders
Frequency: 85 affected / 957 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 16 affected / 957 at risk

Adverse event: Pericardial effusion
Serious: no
Organ System: Cardiac disorders
Frequency: 11 affected / 957 at risk

Adverse event: Sinus node dysfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 957 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 18 affected / 957 at risk

Adverse event: Ventricular fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 957 at risk

Adverse event: Ventricular tachycardia (sustained)
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 957 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Endocrine disorders
Frequency: 19 affected / 957 at risk

Adverse event: Hyperthyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 3 affected / 957 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 5 affected / 957 at risk

Adverse event: Other
Serious: no
Organ System: Endocrine disorders
Frequency: 18 affected / 957 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 957 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 957 at risk

Adverse event: Colonic/intestinal polyp
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 957 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 957 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 957 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 957 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 957 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 957 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 957 at risk

Adverse event: Gastrointestinal ulcer/peptic ulcer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 957 at risk

Adverse event: Gastrooesophageal reflux diseases
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 957 at risk

Adverse event: Hepatobiliary disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 957 at risk

Adverse event: Intestinal obstruction
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 957 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 957 at risk

Adverse event: Other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 61 affected / 957 at risk

Adverse event: Pancreatic disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 957 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 957 at risk

Adverse event: Accidents
Serious: no
Organ System: General disorders
Frequency: 2 affected / 957 at risk

Adverse event: Cataract
Serious: no
Organ System: General disorders
Frequency: 8 affected / 957 at risk

Adverse event: Chest pain (non-cardiac or non-specific)
Serious: no
Organ System: General disorders
Frequency: 26 affected / 957 at risk

Adverse event: Dehydration
Serious: no
Organ System: General disorders
Frequency: 4 affected / 957 at risk

Adverse event: Ear disorders
Serious: no
Organ System: General disorders
Frequency: 2 affected / 957 at risk

Adverse event: Ecchymosis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 957 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 17 affected / 957 at risk

Adverse event: Eye disorders
Serious: no
Organ System: General disorders
Frequency: 9 affected / 957 at risk

Adverse event: Fall
Serious: no
Organ System: General disorders
Frequency: 2 affected / 957 at risk

Adverse event: Fatigue/Weakness
Serious: no
Organ System: General disorders
Frequency: 25 affected / 957 at risk

Adverse event: Fever/Pyrexia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 957 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 3 affected / 957 at risk

Adverse event: Injury
Serious: no
Organ System: General disorders
Frequency: 4 affected / 957 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 56 affected / 957 at risk

Adverse event: Other shock
Serious: no
Organ System: General disorders
Frequency: 1 affected / 957 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 8 affected / 957 at risk

Adverse event: Pruritus
Serious: no
Organ System: General disorders
Frequency: 1 affected / 957 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Frequency: 6 affected / 957 at risk

Adverse event: Allergy to metal
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 957 at risk

Adverse event: Drug hypersensitivity/drug allergy
Serious: no
Organ System: Immune system disorders
Frequency: 11 affected / 957 at risk

Adverse event: Hypersensitivity/allergic reaction
Serious: no
Organ System: Immune system disorders
Frequency: 5 affected / 957 at risk

Adverse event: Other
Serious: no
Organ System: Immune system disorders
Frequency: 7 affected / 957 at risk

Adverse event: Bone and joint infections
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 957 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 957 at risk

Adverse event: Deep sternal wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 957 at risk

Adverse event: Flu/influenza
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 957 at risk

Adverse event: Gastrointestinal infection
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 957 at risk

Adverse event: Genitourinary infection
Serious: no
Organ System: Infections and infestations
Frequency: 43 affected / 957 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 57 affected / 957 at risk

Adverse event: Other
Serious: no
Organ System: Infections and infestations
Frequency: 61 affected / 957 at risk

Adverse event: Skin and subcutaneous infection
Serious: no
Organ System: Infections and infestations
Frequency: 34 affected / 957 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 25 affected / 957 at risk

Adverse event: Vein harvest site infection
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 957 at risk

Adverse event: Catheter site haematoma
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Percutaneous coronary intervention (PCI) complications: access site complications
Frequency: 1 affected / 957 at risk

Adverse event: Other
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Percutaneous coronary intervention (PCI) complications: access site complications
Frequency: 2 affected / 957 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 11 affected / 957 at risk

Adverse event: Blood creatinine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 957 at risk

Adverse event: Elevated cardiac enzymes
Serious: no
Organ System: Investigations
Frequency: 88 affected / 957 at risk

Adverse event: Haematocrit decreased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 957 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 35 affected / 957 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Investigations
Frequency: 16 affected / 957 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Investigations
Frequency: 9 affected / 957 at risk

Adverse event: Hyperlipidaemia/hypercholesterolemia
Serious: no
Organ System: Investigations
Frequency: 4 affected / 957 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 957 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Investigations
Frequency: 11 affected / 957 at risk

Adverse event: Liver function test abnormal
Serious: no
Organ System: Investigations
Frequency: 14 affected / 957 at risk

Adverse event: Other
Serious: no
Organ System: Investigations
Frequency: 37 affected / 957 at risk

Adverse event: Other abnormal blood test
Serious: no
Organ System: Investigations
Frequency: 16 affected / 957 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 16 affected / 957 at risk

Adverse event: Backpain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 23 affected / 957 at risk

Adverse event: Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 30 affected / 957 at risk

Adverse event: Joint or tendon disease/disorder
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 19 affected / 957 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 957 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 60 affected / 957 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 957 at risk

Adverse event: Other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 69 affected / 957 at risk

Adverse event: Spinal disorder
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 957 at risk

Adverse event: Neoplasm/cancer : Blood or lymphatic
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 957 at risk

Adverse event: Neoplasm/cancer : Gastrointestinal
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 5 affected / 957 at risk

Adverse event: Neoplasm/cancer : Musculoskeletal
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 957 at risk

Adverse event: Neoplasm/cancer : Nervous system
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 957 at risk

Adverse event: Neoplasm/cancer : Other
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 16 affected / 957 at risk

Adverse event: Neoplasm/cancer : Reproductive system
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 957 at risk

Adverse event: Neoplasm/cancer : Respiratory
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 6 affected / 957 at risk

Adverse event: Neoplasm/cancer : Skin or subcutaneous
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 11 affected / 957 at risk

Adverse event: Neoplasm/cancer : Urinary
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 10 affected / 957 at risk

Adverse event: Cerebrovascular accident (CVA)
Serious: no
Organ System: Nervous system disorders
Frequency: 36 affected / 957 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 957 at risk

Adverse event: Encephalopathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 957 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 957 at risk

Adverse event: Other : Neurological/psychiatric disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 51 affected / 957 at risk

Adverse event: Seizure/convulsion
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 957 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 957 at risk

Adverse event: Syncope/fainting/loss of consciousness
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 957 at risk

Adverse event: Transient ischemic attack (TIA)
Serious: no
Organ System: Nervous system disorders
Frequency: 18 affected / 957 at risk

Adverse event: Vertigo
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 957 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 957 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 957 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 957 at risk

Adverse event: Dementia
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 957 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 957 at risk

Adverse event: Mental status change (including coma)
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 957 at risk

Adverse event: Psychiatric disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 957 at risk

Adverse event: Benign prostatic hyperplasia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 7 affected / 957 at risk

Adverse event: Incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 957 at risk

Adverse event: Nephrolithiasis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 957 at risk

Adverse event: Other
Serious: no
Organ System: Renal and urinary disorders
Frequency: 40 affected / 957 at risk

Adverse event: Renal artery stenosis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 957 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 24 affected / 957 at risk

Adverse event: Renal insufficiency/impairment
Serious: no
Organ System: Renal and urinary disorders
Frequency: 28 affected / 957 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 957 at risk

Adverse event: Urinary stone/calculus
Serious: no
Organ System: Renal and urinary disorders
Frequency: 9 affected / 957 at risk

Adverse event: Urinary tract obstruction
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 957 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 957 at risk

Adverse event: COPD (chronic obstructive pulmonary disease)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 19 affected / 957 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 21 affected / 957 at risk

Adverse event: Dyspnea/shortness of breath
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 57 affected / 957 at risk

Adverse event: Other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 101 affected / 957 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 63 affected / 957 at risk

Adverse event: Pneumonitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 957 at risk

Adverse event: Pulmonary embolism
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 957 at risk

Adverse event: Respiratory failure
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 38 affected / 957 at risk

Adverse event: Aneurysm
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 957 at risk

Adverse event: Arteriovenous fistula
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 957 at risk

Adverse event: Intermittent claudication
Serious: no
Organ System: Vascular disorders
Frequency: 16 affected / 957 at risk

Adverse event: Deep vein thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 957 at risk

Adverse event: Embolism
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 957 at risk

Adverse event: Other
Serious: no
Organ System: Vascular disorders
Frequency: 19 affected / 957 at risk

Adverse event: Peripheral artery disease/peripheral venous disease
Serious: no
Organ System: Vascular disorders
Frequency: 27 affected / 957 at risk

Adverse event: Peripheral nerve lesion/injury
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 957 at risk

Adverse event: Vascular pseudoaneurysm
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 957 at risk

Adverse event: Stenosis
Serious: no
Organ System: Vascular disorders
Frequency: 11 affected / 957 at risk

Adverse event: Thrombophlebitis
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 957 at risk

Adverse event: Thrombosis (non stent/non-coronary)
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 957 at risk

Adverse event: Vascular occlusion
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 957 at risk