Study: NCT02447081

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1088 at risk

Adverse event: Acute bacterial endocarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 1088 at risk

Adverse event: Acute erosive gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 1088 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 1088 at risk

Adverse event: Pancreatitis acute
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Acute pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1088 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 20 affected / 1088 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Adult respiratory distress syndrome(ARDS)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Air embolus
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Alcohol poisoning
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1088 at risk

Adverse event: Anemias
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 26 affected / 1088 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 1088 at risk

Adverse event: Aortic dissection
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1088 at risk

Adverse event: Aortic value stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 1088 at risk

Adverse event: Aphasia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Upper limb fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 1088 at risk

Adverse event: Arterial hypertension/Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 1088 at risk

Adverse event: Ascites
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 1088 at risk

Adverse event: Aspiration Pneumonia/Necrotizing pneumonia/Aspiration of vomitus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 1088 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 37 affected / 1088 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 1088 at risk

Adverse event: Atrial tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1088 at risk

Adverse event: Atrioventricular block
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 1088 at risk

Adverse event: Atrioventricular dissociation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Bacterial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 19 affected / 1088 at risk

Adverse event: Bacterial infections of the skin
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 1088 at risk

Adverse event: Benign Tumors
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1088 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 1088 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1088 at risk

Adverse event: Brain neoplasm
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1088 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1088 at risk

Adverse event: Burns
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1088 at risk

Adverse event: Bursitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 23 affected / 1088 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 12 affected / 1088 at risk

Adverse event: Cardiac Decompensation
Serious: yes
Organ System: Cardiac disorders
Frequency: 15 affected / 1088 at risk

Adverse event: Cardiac perforation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1088 at risk

Adverse event: Cerebral Aneurysm
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 1088 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 1088 at risk

Adverse event: Choledocholithiaisis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 1088 at risk

Adverse event: Chronic Obstructive Pulmonary Disease (COPD)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1088 at risk

Adverse event: Chronic kidney disease
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 1088 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Clostridum difficile Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 1088 at risk

Adverse event: Cognitive disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 1088 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 1088 at risk

Adverse event: Compression fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1088 at risk

Adverse event: Confusional state
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 1088 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 13 affected / 1088 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1088 at risk

Adverse event: Cutaneous Abcesses
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 62 affected / 1088 at risk

Adverse event: Deep Vein/Venous Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 1088 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Delirium
Serious: yes
Organ System: Psychiatric disorders
Frequency: 4 affected / 1088 at risk

Adverse event: Dementia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Device embolisation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 1088 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 1088 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 1088 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Diverticulum intestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Adverse drug reaction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Duodenal ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1088 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1088 at risk

Adverse event: EKG Abnormalities
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Elective Cardiac Surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1088 at risk

Adverse event: Emesis/Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Epididymitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1088 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1088 at risk

Adverse event: Eye Bleed
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 9 affected / 1088 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 1088 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 1088 at risk

Adverse event: Fungal skin infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1088 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 1088 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 1088 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 57 affected / 1088 at risk

Adverse event: Impaired gastric emptying
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Generalized Seizures
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Glaucoma
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Gout
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 1088 at risk

Adverse event: Hallucination
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Atrioventricular block
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 1088 at risk

Adverse event: Dyspepsia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Haematemesis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Haematochezia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1088 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 1088 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 12 affected / 1088 at risk

Adverse event: Hemiblock (Fascicular Block)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Haemoperitoneum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Haemoptysis
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1088 at risk

Adverse event: Hepatic and Biliary Disorders
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Hernia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Joint dislocation
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 1088 at risk

Adverse event: Hip Pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Hypertensive crisis
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 1088 at risk

Adverse event: Hyperthyroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 1088 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 1088 at risk

Adverse event: Hypothermia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Hypoventilation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Infective/Bacterial Endocarditis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1088 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1088 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 10 affected / 1088 at risk

Adverse event: Iron-Deficiency Anemia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 1088 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Cardiac disorders
Frequency: 39 affected / 1088 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Leukemias
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 1088 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 1088 at risk

Adverse event: Spinal osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 7 affected / 1088 at risk

Adverse event: Malignant melanoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1088 at risk

Adverse event: Melaena
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 1088 at risk

Adverse event: Miscellaneous Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1088 at risk

Adverse event: Mitral Valve Regurgitation/Mitral Insufficiency
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 1088 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 1088 at risk

Adverse event: Musculoskeletal pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 1088 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 1088 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 1088 at risk

Adverse event: Neurological Hematoma
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1088 at risk

Adverse event: Eye haemorrhage
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Orthostatic hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Osler Weber Rendu Syndrome
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Osteoarthritis/Degenerative Joint Disease
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 1088 at risk

Adverse event: Overdose
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1088 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Pancreatic carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 1088 at risk

Adverse event: Parkinson's disease
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Atrial tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Perforated Appendix
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 1088 at risk

Adverse event: Cardiac tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 1088 at risk

Adverse event: Peripheral Arterial Occlusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 1088 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 1088 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1088 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 1088 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 33 affected / 1088 at risk

Adverse event: Pneumonia Caused By Gram-Negative Bacilli
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1088 at risk

Adverse event: Pneumonia in the Compromised Host
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1088 at risk

Adverse event: Polyneuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Portal-Systemic Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Pressure Sores
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Presyncope
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 1088 at risk

Adverse event: Primary biliary cholangitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 1088 at risk

Adverse event: Psychogenic Event
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 1088 at risk

Adverse event: Raynaud's phenomenon
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 1088 at risk

Adverse event: Renal failure
Serious: yes
Organ System: General disorders
Frequency: 9 affected / 1088 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 1088 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1088 at risk

Adverse event: Rheumotologic Disease
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Right ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Second Degree Heart Block
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Seizure/Convulsions/Epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 14 affected / 1088 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 19 affected / 1088 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1088 at risk

Adverse event: Shock
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 1088 at risk

Adverse event: Sinus node dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1088 at risk

Adverse event: Simple partial seizures
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Sinus Bradycardia/Sinus Bradycardia (Cardiac Arrhythmia)
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1088 at risk

Adverse event: Skin cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 1088 at risk

Adverse event: Skin ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 1088 at risk

Adverse event: Spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Status epilepticus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Subdural haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Sustained Atrial Fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Syncope
Serious: yes
Organ System: General disorders
Frequency: 11 affected / 1088 at risk

Adverse event: TEE-Related Event
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Third Degree Heart Block (Complete Heart Block)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Thrombus on Device
Serious: yes
Organ System: Cardiac disorders
Frequency: 19 affected / 1088 at risk

Adverse event: Torsade de pointes
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Transient Ischemic Attack (TIA)
Serious: yes
Organ System: General disorders
Frequency: 14 affected / 1088 at risk

Adverse event: Injury
Serious: yes
Organ System: General disorders
Frequency: 9 affected / 1088 at risk

Adverse event: Tricuspid Regurgitation/Tricuspid Insufficiency/Valvular Regurgitation Valve
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 1088 at risk

Adverse event: Unsustained/Nonsustained Ventricular Tachy/Cardiac Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Urethral Dysfunction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 7 affected / 1088 at risk

Adverse event: Urinary Tract Infections
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 11 affected / 1088 at risk

Adverse event: VASC AV Fistula
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 4 affected / 1088 at risk

Adverse event: VASC Bleeding
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 1088 at risk

Adverse event: VASC Hematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 1088 at risk

Adverse event: VASC Pseudoaneurysm
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 1088 at risk

Adverse event: Vascular dissection
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Vascular Ischemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1088 at risk

Adverse event: Vaso Vagal Response
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Ventricular fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1088 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 1088 at risk

Adverse event: Vessel Occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1088 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Wound dehiscence
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1088 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Frequency: 50 affected / 1088 at risk