Study: NCT03200574

Adverse event: Access site haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 88 at risk

Adverse event: Bleeding disorders
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 88 at risk

Adverse event: Blood disorders
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 88 at risk

Adverse event: Arrhythmias and conduction disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 12 affected / 88 at risk

Adverse event: Cardiac arrest/cardiorespiratory arrest
Serious: yes
Organ System: Cardiac disorders
Notes: leading to death
Frequency: 1 affected / 88 at risk

Adverse event: Cardiac decompensation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 88 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 88 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 88 at risk

Adverse event: Thrombosis, Valve
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 88 at risk

Adverse event: Gastrointestinal and hepatobiliary disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 88 at risk

Adverse event: Chest pain, noncardiac
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 88 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 88 at risk

Adverse event: Laboratory test abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 88 at risk

Adverse event: Injuries, Trauma, Social circumstances
Serious: yes
Organ System: Social circumstances
Frequency: 2 affected / 88 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 88 at risk

Adverse event: Confusion, Delirium
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 88 at risk

Adverse event: Dizziness / Vertigo
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 88 at risk

Adverse event: Hypoaesthesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 88 at risk

Adverse event: Other Neurologic Disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 88 at risk

Adverse event: Stroke (CVA)
Serious: yes
Organ System: Nervous system disorders
Notes: 1 case of Stroke led to death
Frequency: 5 affected / 88 at risk

Adverse event: Syncope / loss of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 88 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 88 at risk

Adverse event: Other renal and genitourinary disorders
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 88 at risk

Adverse event: Dyspnoea/Shortness of breath
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 88 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 88 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: leading to death
Frequency: 1 affected / 88 at risk

Adverse event: Arterial stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 88 at risk

Adverse event: Embolization (air, tissue, septic, device)
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 88 at risk

Adverse event: Peripheral artery stenosis/peripheral vaso-occlusive disease/peripheral vascular disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 88 at risk

Adverse event: Thrombophlebitis
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 88 at risk

Adverse event: Thrombosis, deep vein
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 88 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 88 at risk

Adverse event: Access site infection
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 88 at risk

Adverse event: Other access site complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 88 at risk

Adverse event: Other cardiac disorder
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 88 at risk

Adverse event: Death unknown cause
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 88 at risk

Adverse event: Other general system disorders
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 88 at risk

Adverse event: Genitourinary infections
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 88 at risk

Adverse event: Respiratory system infections
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 88 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 88 at risk

Adverse event: Skin and subcutaneous infections
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 88 at risk