Study: NCT02675244

Adverse event: Haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 12 affected / 203 at risk

Adverse event: Cardiac Arrhythmias - Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 203 at risk

Adverse event: Cardiac Arrhythmias - Sustained ventricular arrhythmia requiring defibrillation or cardioversion
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 203 at risk

Adverse event: Cardiac Arrhythmias - Sustained supraventricular arrhythmia requiring drug treatment or cardioversio
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 45 affected / 203 at risk

Adverse event: Cardiac Arrhythmias - Cardiac conduction abnormalities or sustained bradycardia requiring PPM
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 203 at risk

Adverse event: Pericardial Fluid Collection
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 203 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 203 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 203 at risk

Adverse event: Hepatic Dysfunction
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 203 at risk

Adverse event: Major Infection - Localized
Serious: yes
Organ System: Infections and infestations
Frequency: 15 affected / 203 at risk

Adverse event: Major Infection - Endocarditis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 203 at risk

Adverse event: Major Infection - Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 203 at risk

Adverse event: Myocardial Infarction (Non- Procedure Related)
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 203 at risk

Adverse event: Myocardial Infarction - Peri-CABG
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 203 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 203 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 203 at risk

Adverse event: Haemorrhagic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 203 at risk

Adverse event: Toxic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 203 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 203 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 5 affected / 203 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 203 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 13 affected / 203 at risk

Adverse event: Arterial Non-CNS Thromboembolism
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 203 at risk

Adverse event: Venous Thromboembolic Event
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 203 at risk

Adverse event: Other SAE
Serious: yes
Organ System: General disorders
Frequency: 47 affected / 203 at risk

Adverse event: Neurological Dysfunction - Other
Serious: yes
Organ System: Nervous system disorders
Notes: SAE term did not meet specific CTCAE event criteria
Frequency: 1 affected / 203 at risk

Adverse event: Cardiac Arrhythmias -Sustained supraventricular arrhythmia requiring drug treatment or cardioversion
Serious: no
Organ System: Cardiac disorders
Frequency: 57 affected / 203 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 203 at risk

Adverse event: Major Infection - Localized
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 203 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 7 affected / 198 at risk

Adverse event: Cardiac Arrhythmias - Sustained ventricular arrhythmia requiring defibrillation or cardioversion
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 198 at risk

Adverse event: Cardiac Arrhythmias - Sustained supraventricular arrhythmia requiring drug treatment or cardioversio
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 30 affected / 198 at risk

Adverse event: Cardiac Arrhythmias - Cardiac conduction abnormalities or sustained bradycardia requiring PPM
Serious: yes
Organ System: Cardiac disorders
Frequency: 28 affected / 198 at risk

Adverse event: Pericardial Fluid Collection
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 198 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 198 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 198 at risk

Adverse event: Major Infection - Localized
Serious: yes
Organ System: Infections and infestations
Frequency: 15 affected / 198 at risk

Adverse event: Major Infection - Endocarditis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 198 at risk

Adverse event: Major Infection - Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 198 at risk

Adverse event: Myocardial Infarction (Non- Procedure Related)
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 198 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 198 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Vascular disorders
Frequency: 9 affected / 198 at risk

Adverse event: Haemorrhagic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 198 at risk

Adverse event: Toxic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 198 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 198 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 198 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 198 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 198 at risk

Adverse event: Wound dehiscence
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 198 at risk

Adverse event: Other SAE
Serious: yes
Organ System: General disorders
Frequency: 37 affected / 198 at risk

Adverse event: Cardiac Arrhythmias -Sustained supraventricular arrhythmia requiring drug treatment or cardioversion
Serious: no
Organ System: Cardiac disorders
Frequency: 44 affected / 198 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 198 at risk

Adverse event: Major Infection - Localized
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 198 at risk