Study: NCT01092416

Adverse event: Acute MI, Q-wave
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 443 at risk

Adverse event: Acute MI, non Q-wave
Serious: yes
Organ System: Cardiac disorders
Frequency: 39 affected / 443 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 443 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 443 at risk

Adverse event: Atrioventricular block, II degree
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 443 at risk

Adverse event: Cardiac/pericardial tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 443 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 443 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 443 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 443 at risk

Adverse event: Arterial revascularisation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 443 at risk

Adverse event: PEA arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 443 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 443 at risk

Adverse event: Shock (Acute RV dysfunction and acute blood loss hypovolemic)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 443 at risk

Adverse event: Sinus node dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 443 at risk

Adverse event: Ventricular fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 443 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 443 at risk

Adverse event: Ventricular tachycardia/ventricular fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 443 at risk

Adverse event: Coronary artery embolism of air, plaque, thrombosis, or debris
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 443 at risk

Adverse event: Slow flow or no reflow phenomena
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 443 at risk

Adverse event: Thrombosis formation at site of treated lesion
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 443 at risk

Adverse event: Hematoma at access site, requiring intervention
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 443 at risk

Adverse event: Hemorrhage, major, requiring transfusion
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 443 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 443 at risk

Adverse event: Peripheral artery pseudoaneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 443 at risk

Adverse event: Peripheral artery/vascular disease
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 443 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 443 at risk

Adverse event: Cerebrovascular accident (CVA)
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 443 at risk

Adverse event: Sundowning/ICU "psychosis"
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 443 at risk

Adverse event: Anoxia due to aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 443 at risk

Adverse event: Aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 443 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 443 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 443 at risk

Adverse event: Dyspnea/Shortness of breath
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 443 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 443 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 443 at risk

Adverse event: Respiratory failure, requiring intubation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 443 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 443 at risk

Adverse event: Oesophageal spasm
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 443 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 443 at risk

Adverse event: Nausea and/or vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 443 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 443 at risk

Adverse event: Urinary tract infection (UTI)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 443 at risk

Adverse event: Cardiac death
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 443 at risk

Adverse event: Non-cardiac death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 443 at risk

Adverse event: Bone fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 443 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 443 at risk

Adverse event: Infection at access site
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 443 at risk

Adverse event: Left arm AV graft infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 443 at risk

Adverse event: Lower extremity pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 443 at risk

Adverse event: Coronary vessel dissection present
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 23 affected / 443 at risk

Adverse event: Coronary vessel perforation present
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 8 affected / 443 at risk

Adverse event: Non-coronary right ventricle vessel perforation present
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 443 at risk

Adverse event: Angiographic Complications
Serious: no
Organ System: Surgical and medical procedures
Frequency: 34 affected / 443 at risk

Adverse event: Acute MI, non Q-wave
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 438 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 23 affected / 438 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 438 at risk

Adverse event: Atrioventricular block, II degree
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 438 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 438 at risk

Adverse event: Arterial revascularisation
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 438 at risk

Adverse event: Sinus node dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 438 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 438 at risk

Adverse event: Peripheral artery/vascular disease
Serious: yes
Organ System: Vascular disorders
Frequency: 9 affected / 438 at risk

Adverse event: Cerebrovascular accident (CVA)
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 438 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 438 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 438 at risk

Adverse event: Dyspnea/Shortness of breath
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 438 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 438 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 438 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 438 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 438 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 438 at risk

Adverse event: Urinary tract infection (UTI)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 5 affected / 438 at risk

Adverse event: Cardiac death
Serious: yes
Organ System: Cardiac disorders
Frequency: 12 affected / 438 at risk

Adverse event: Non-cardiac death
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 438 at risk

Adverse event: Bone fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 438 at risk

Adverse event: Acute congestive heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 438 at risk

Adverse event: Aortic valve stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 438 at risk

Adverse event: Arrhythmia, unspecified
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 438 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 438 at risk

Adverse event: Cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 438 at risk

Adverse event: Chronic congestive heart failure, or exacerbation
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 438 at risk

Adverse event: Coronary artery restenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 20 affected / 438 at risk

Adverse event: Heart flutter/nervous feeling in chest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 438 at risk

Adverse event: Myocarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 438 at risk

Adverse event: Pacemaker end of life
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 438 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 438 at risk

Adverse event: Sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 438 at risk

Adverse event: Carotid artery disease
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 438 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 438 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 438 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 438 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 438 at risk

Adverse event: Cerebral artery aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 438 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 438 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 438 at risk

Adverse event: Panic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 438 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 438 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 8 affected / 438 at risk

Adverse event: Tinnitus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 438 at risk

Adverse event: Transient ischemic attack (TIA)
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 438 at risk

Adverse event: Presyncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 438 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 438 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 438 at risk

Adverse event: Multiple lymphadenopathy (on chest CT)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 438 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 438 at risk

Adverse event: Perforation bile duct
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 438 at risk

Adverse event: Biloma
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 438 at risk

Adverse event: Cirrhosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 438 at risk

Adverse event: Complicated appendicitis (rupture)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 438 at risk

Adverse event: Complications post cholecystectomy
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 438 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 438 at risk

Adverse event: Duodenal ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 438 at risk

Adverse event: Elevated liver function tests
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 438 at risk

Adverse event: Gallstone
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 438 at risk

Adverse event: Gangrenous gallbladder
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 438 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 438 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 438 at risk

Adverse event: Impaired gastric emptying
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 438 at risk

Adverse event: Rectocoele repair
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 438 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 6 affected / 438 at risk

Adverse event: Chronic renal failure, or exacerbation
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 438 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 438 at risk

Adverse event: Urinary tract obstruction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 438 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 438 at risk

Adverse event: Pollakiuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 5 affected / 438 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 438 at risk

Adverse event: Anticoagulation drug level above therapeutic
Serious: yes
Organ System: General disorders
Notes: International Normalized Ratio/Prothrombin time
Frequency: 1 affected / 438 at risk

Adverse event: Death, unknown cause
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 438 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 438 at risk

Adverse event: Arthroplasty revision
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 438 at risk

Adverse event: Back pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 438 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 438 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 438 at risk

Adverse event: Bladder cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 438 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 438 at risk

Adverse event: Carpal tunnel syndrome
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 438 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 438 at risk

Adverse event: Chest pain, non-cardiac
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 438 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 438 at risk

Adverse event: Fall/Loss of balance
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 438 at risk

Adverse event: Gout
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 438 at risk

Adverse event: Hernia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 438 at risk

Adverse event: Infection at pacemaker site
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 438 at risk

Adverse event: Thyroid neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 438 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 438 at risk

Adverse event: Metabolic acidosis
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 438 at risk

Adverse event: Myelodysplastic syndrome
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 438 at risk

Adverse event: Plasma cell myeloma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 438 at risk

Adverse event: Pancytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 438 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 438 at risk

Adverse event: Rectal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 438 at risk

Adverse event: Gynaecomastia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 438 at risk

Adverse event: Knee arthroplasty
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 438 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 438 at risk

Adverse event: Skin infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 438 at risk

Adverse event: Spinal stenosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 438 at risk

Adverse event: Injury
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 438 at risk

Adverse event: Gangrene
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 438 at risk