Study: NCT02964208

Adverse event: Anemias
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 17 affected / 520 at risk

Adverse event: Iron-Deficiency Anemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 520 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 520 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 520 at risk

Adverse event: Cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 520 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 520 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 520 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 520 at risk

Adverse event: Mitral Valve Regurgitation/Mitral Insufficiency
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 520 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 520 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 520 at risk

Adverse event: Cardiac tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 520 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 520 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 520 at risk

Adverse event: Sinus Bradycardia/Sinus Bradycardia (Cardiac Arrhythmia)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 520 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 520 at risk

Adverse event: Retinal haemorrhage
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 520 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 520 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 520 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 35 affected / 520 at risk

Adverse event: Ascites
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 520 at risk

Adverse event: Change in Gait
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 520 at risk

Adverse event: Dizziness
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 520 at risk

Adverse event: Failure to thrive
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 520 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 520 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 520 at risk

Adverse event: Hepatic and Biliary Disorders
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 520 at risk

Adverse event: Pancreatic carcinoma
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 520 at risk

Adverse event: Acute Bacterial Endocarditis (ABE)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 520 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 520 at risk

Adverse event: Aspiration Pneumonia/Necrotizing Pneumonia/Aspiration of Vomitus
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 520 at risk

Adverse event: Pneumonia chlamydial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 520 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 520 at risk

Adverse event: Pneumonia Caused By Gram-Negative Bacilli
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 520 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 520 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 520 at risk

Adverse event: Urinary Tract Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 520 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 520 at risk

Adverse event: Craniocerebral injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 520 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 520 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 520 at risk

Adverse event: Injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 520 at risk

Adverse event: Abnormal Lab Value
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 520 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 6 affected / 520 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 520 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 520 at risk

Adverse event: Delirium
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 520 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 520 at risk

Adverse event: Incidental Finding of Stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 520 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 9 affected / 520 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 17 affected / 520 at risk

Adverse event: Myoclonus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 520 at risk

Adverse event: Paresthesia/Paraesthesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 520 at risk

Adverse event: Seizure/Convulsions/Epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 520 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 520 at risk

Adverse event: Transient Ischemic Attack (TIA)
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 520 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 520 at risk

Adverse event: Device dislocation
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 520 at risk

Adverse event: Thrombus on Device
Serious: yes
Organ System: Product Issues
Frequency: 3 affected / 520 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 520 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 520 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 520 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 5 affected / 520 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 520 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 520 at risk

Adverse event: Haemoptysis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 520 at risk

Adverse event: Haemothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 520 at risk

Adverse event: Idiopathic Interstitial Lung Diseases
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 520 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 520 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 520 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 520 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 520 at risk

Adverse event: Haemarthrosis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 520 at risk

Adverse event: Seroma
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 520 at risk

Adverse event: Arterial Hypertension/Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 520 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 520 at risk

Adverse event: Carotid Aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 520 at risk

Adverse event: Deep Vein/Venous Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 520 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 7 affected / 520 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 520 at risk

Adverse event: Hypertensive crisis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 520 at risk

Adverse event: Perforation of Vessel
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 520 at risk

Adverse event: Peripheral Arterial Occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 520 at risk

Adverse event: Syncope
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 520 at risk

Adverse event: VASC Bleeding
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 520 at risk

Adverse event: VASC Pseudoaneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 520 at risk

Adverse event: Thrombus on Device
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 520 at risk

Adverse event: Transient Ischemic Attack (TIA)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 520 at risk

Adverse event: Angina unstable
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 520 at risk