Study: NCT02224755

Adverse event: Arterial Non-CNS Thromboembolism
Serious: yes
Organ System: Vascular disorders
Frequency: 10 affected / 505 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 271 affected / 505 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 174 affected / 505 at risk

Adverse event: Hepatic Dysfunction
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 23 affected / 505 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 18 affected / 505 at risk

Adverse event: Major Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 251 affected / 505 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 505 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 98 affected / 505 at risk

Adverse event: Other Neurological Event
Serious: yes
Organ System: Nervous system disorders
Frequency: 47 affected / 505 at risk

Adverse event: Pericardial Fluid Collection
Serious: yes
Organ System: Cardiac disorders
Frequency: 44 affected / 505 at risk

Adverse event: Psychiatric Episode
Serious: yes
Organ System: Psychiatric disorders
Frequency: 24 affected / 505 at risk

Adverse event: Renal Dysfunction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 52 affected / 505 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 94 affected / 505 at risk

Adverse event: Right ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 127 affected / 505 at risk

Adverse event: Embolism venous
Serious: yes
Organ System: Vascular disorders
Frequency: 14 affected / 505 at risk

Adverse event: Wound dehiscence
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 505 at risk

Adverse event: Suspected Device Thrombosis
Serious: yes
Organ System: Product Issues
Frequency: 70 affected / 505 at risk

Adverse event: Haemolysis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 505 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Frequency: 277 affected / 505 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 26 affected / 505 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 46 affected / 505 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 29 affected / 505 at risk

Adverse event: Major Infection
Serious: no
Organ System: Infections and infestations
Frequency: 79 affected / 505 at risk

Adverse event: Psychiatric Episode
Serious: no
Organ System: Psychiatric disorders
Frequency: 21 affected / 505 at risk

Adverse event: Right ventricular failure
Serious: no
Organ System: Cardiac disorders
Frequency: 19 affected / 505 at risk

Adverse event: Other Adverse Event
Serious: no
Organ System: General disorders
Frequency: 113 affected / 505 at risk

Adverse event: Arterial Non-CNS Thromboembolism
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 515 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 214 affected / 515 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 149 affected / 515 at risk

Adverse event: Hepatic Dysfunction
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 20 affected / 515 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 23 affected / 515 at risk

Adverse event: Major Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 274 affected / 515 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 515 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 51 affected / 515 at risk

Adverse event: Other Neurological Event
Serious: yes
Organ System: Nervous system disorders
Frequency: 59 affected / 515 at risk

Adverse event: Pericardial Fluid Collection
Serious: yes
Organ System: Cardiac disorders
Frequency: 25 affected / 515 at risk

Adverse event: Psychiatric Episode
Serious: yes
Organ System: Psychiatric disorders
Frequency: 31 affected / 515 at risk

Adverse event: Renal Dysfunction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 70 affected / 515 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 110 affected / 515 at risk

Adverse event: Right ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 151 affected / 515 at risk

Adverse event: Embolism venous
Serious: yes
Organ System: Vascular disorders
Frequency: 20 affected / 515 at risk

Adverse event: Wound dehiscence
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 515 at risk

Adverse event: Suspected Device Thrombosis
Serious: yes
Organ System: Product Issues
Frequency: 7 affected / 515 at risk

Adverse event: Haemolysis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 515 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Frequency: 340 affected / 515 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 31 affected / 515 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 54 affected / 515 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 19 affected / 515 at risk

Adverse event: Major Infection
Serious: no
Organ System: Infections and infestations
Frequency: 95 affected / 515 at risk

Adverse event: Psychiatric Episode
Serious: no
Organ System: Psychiatric disorders
Frequency: 24 affected / 515 at risk

Adverse event: Right ventricular failure
Serious: no
Organ System: Cardiac disorders
Frequency: 28 affected / 515 at risk

Adverse event: Other Adverse Event
Serious: no
Organ System: General disorders
Frequency: 139 affected / 515 at risk