Study: NCT01802788

Adverse event: Clinical significant bleeding
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 67 affected / 941 at risk

Adverse event: Life threatening bleeding
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 31 affected / 941 at risk

Adverse event: Major bleeding
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 74 affected / 941 at risk

Adverse event: Minor bleeding
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 941 at risk

Adverse event: Not clinical significant bleeding
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 17 affected / 941 at risk

Adverse event: Arrhythmia / Conduction abnormality
Serious: yes
Organ System: Cardiac disorders
Frequency: 256 affected / 941 at risk

Adverse event: Coronary obstruction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 941 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 941 at risk

Adverse event: New Onset of Atrial Fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 25 affected / 941 at risk

Adverse event: Peri-Procedural MI
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 941 at risk

Adverse event: Prosthetic aortic valve regurgitation
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 941 at risk

Adverse event: Prosthetic cardiac valve stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 941 at risk

Adverse event: Spontaneous MI
Serious: yes
Organ System: Cardiac disorders
Frequency: 34 affected / 941 at risk

Adverse event: Disabling stroke
Serious: yes
Organ System: General disorders
Frequency: 53 affected / 941 at risk

Adverse event: Non-Disabling stroke
Serious: yes
Organ System: General disorders
Frequency: 35 affected / 941 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Frequency: 597 affected / 941 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: General disorders
Frequency: 17 affected / 941 at risk

Adverse event: Stage 1 AKI
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 6 affected / 941 at risk

Adverse event: Stage 2 AKI
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 8 affected / 941 at risk

Adverse event: Stage 3 AKI
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 39 affected / 941 at risk

Adverse event: Undetermined AKI
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 13 affected / 941 at risk

Adverse event: Need for second TAVI
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 8 affected / 941 at risk

Adverse event: Pacemaker implantation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 204 affected / 941 at risk

Adverse event: Major vascular complications
Serious: yes
Organ System: Vascular disorders
Frequency: 65 affected / 941 at risk

Adverse event: Minor vascular complications
Serious: yes
Organ System: Vascular disorders
Frequency: 14 affected / 941 at risk

Adverse event: Clinical significant bleeding
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 941 at risk

Adverse event: Life threatening bleeding
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 941 at risk

Adverse event: Major bleeding
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 941 at risk

Adverse event: Minor bleeding
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 69 affected / 941 at risk

Adverse event: Not clinical significant bleeding
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 941 at risk

Adverse event: Endocarditis
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 941 at risk

Adverse event: New Onset of Atrial Fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 50 affected / 941 at risk

Adverse event: Peri-Procedural MI
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 941 at risk

Adverse event: Prosthetic aortic valve regurgitation
Serious: no
Organ System: Cardiac disorders
Frequency: 27 affected / 941 at risk

Adverse event: Prosthetic cardiac valve stenosis
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 941 at risk

Adverse event: Arrhythmia / Conduction abnormality
Serious: no
Organ System: Cardiac disorders
Frequency: 284 affected / 941 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 312 affected / 941 at risk

Adverse event: Transient ischaemic attack
Serious: no
Organ System: General disorders
Frequency: 5 affected / 941 at risk

Adverse event: Stage 1 AKI
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 941 at risk

Adverse event: Stage 2 AKI
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 941 at risk

Adverse event: Stage 3 AKI
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 941 at risk

Adverse event: Undetermined AKI
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 941 at risk

Adverse event: Need for second TAVI
Serious: no
Organ System: Surgical and medical procedures
Frequency: 5 affected / 941 at risk

Adverse event: Pacemaker implantation
Serious: no
Organ System: Surgical and medical procedures
Frequency: 8 affected / 941 at risk

Adverse event: Major vascular complications
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 941 at risk

Adverse event: Minor vascular complications
Serious: no
Organ System: Vascular disorders
Frequency: 45 affected / 941 at risk

Adverse event: Undetermined vascular complications
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 941 at risk

Adverse event: Clinical significant bleeding
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 59 at risk

Adverse event: Not clinical significant bleeding
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 59 at risk

Adverse event: Arrhythmia / Conduction abnormality
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 59 at risk

Adverse event: New Onset of Atrial Fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 59 at risk

Adverse event: Spontaneous MI
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 59 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Frequency: 33 affected / 59 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 59 at risk

Adverse event: Undetermined AKI
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 59 at risk

Adverse event: Pacemaker implantation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 59 at risk

Adverse event: New Onset of Atrial Fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 59 at risk

Adverse event: Arrhythmia / Conduction abnormality
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 59 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 17 affected / 59 at risk

Adverse event: Stage 2 AKI
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 59 at risk