Study: NCT02214277

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 244 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 13 affected / 244 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 244 at risk

Adverse event: Abnormal Lab Value
Serious: no
Organ System: General disorders
Frequency: 15 affected / 244 at risk

Adverse event: Access Site Hematoma
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: All vascular access sites , including Sentinel (radial, brachial) and TAVR access
Frequency: 13 affected / 244 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 23 affected / 244 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 13 affected / 244 at risk

Adverse event: Cardiac arrest
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 244 at risk

Adverse event: Bleed, Operative or Post-Operative
Serious: no
Organ System: General disorders
Frequency: 12 affected / 244 at risk

Adverse event: Conduction System Injury
Serious: no
Organ System: Cardiac disorders
Frequency: 42 affected / 244 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 15 affected / 244 at risk

Adverse event: Hypertension
Serious: no
Organ System: General disorders
Frequency: 11 affected / 244 at risk

Adverse event: Neurological Event, Imaging Only
Serious: no
Organ System: Nervous system disorders
Frequency: 30 affected / 244 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 53 affected / 244 at risk

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 119 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 10 affected / 119 at risk

Adverse event: Abnormal Lab Value
Serious: no
Organ System: General disorders
Frequency: 8 affected / 119 at risk

Adverse event: Access Site Hematoma
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: All vascular access sites , including Sentinel (radial, brachial) and TAVR access
Frequency: 6 affected / 119 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 119 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 119 at risk

Adverse event: Cardiac arrest
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 119 at risk

Adverse event: Bleed, Operative or Post-Operative
Serious: no
Organ System: General disorders
Frequency: 6 affected / 119 at risk

Adverse event: Conduction System Injury
Serious: no
Organ System: Cardiac disorders
Frequency: 30 affected / 119 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 119 at risk

Adverse event: Hypertension
Serious: no
Organ System: General disorders
Frequency: 9 affected / 119 at risk

Adverse event: Neurological Event, Imaging Only
Serious: no
Organ System: Nervous system disorders
Frequency: 23 affected / 119 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 30 affected / 119 at risk