Study: NCT01166347

Adverse event: Major Bleeding
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 170 affected / 296 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 98 affected / 296 at risk

Adverse event: Device malfunction
Serious: yes
Organ System: Product Issues
Frequency: 71 affected / 296 at risk

Adverse event: Haemolysis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 25 affected / 296 at risk

Adverse event: Hepatic Dysfunction
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 14 affected / 296 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 32 affected / 296 at risk

Adverse event: Major Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 185 affected / 296 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 296 at risk

Adverse event: Neurological Dysfunction
Serious: yes
Organ System: Nervous system disorders
Frequency: 97 affected / 296 at risk

Adverse event: Pericardial Fluid Collection
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 296 at risk

Adverse event: Psychiatric Episode
Serious: yes
Organ System: Psychiatric disorders
Frequency: 34 affected / 296 at risk

Adverse event: Renal Dysfunction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 43 affected / 296 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 81 affected / 296 at risk

Adverse event: Right ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 99 affected / 296 at risk

Adverse event: Arterial Non-CNS Thromboembolism
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 296 at risk

Adverse event: Embolism venous
Serious: yes
Organ System: Vascular disorders
Frequency: 8 affected / 296 at risk

Adverse event: Other Intermacs
Serious: yes
Organ System: General disorders
Frequency: 226 affected / 296 at risk

Adverse event: Major Bleeding
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 26 affected / 296 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 22 affected / 296 at risk

Adverse event: Device Malfunction/Failure
Serious: no
Organ System: Product Issues
Frequency: 28 affected / 296 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 18 affected / 296 at risk

Adverse event: Major Infection
Serious: no
Organ System: Infections and infestations
Frequency: 54 affected / 296 at risk

Adverse event: Psychiatric Episode
Serious: no
Organ System: Psychiatric disorders
Frequency: 17 affected / 296 at risk

Adverse event: Right ventricular failure
Serious: no
Organ System: Cardiac disorders
Frequency: 19 affected / 296 at risk

Adverse event: Major Bleeding
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 87 affected / 149 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 55 affected / 149 at risk

Adverse event: Device malfunction
Serious: yes
Organ System: Product Issues
Frequency: 34 affected / 149 at risk

Adverse event: Haemolysis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 149 at risk

Adverse event: Hepatic Dysfunction
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 11 affected / 149 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 18 affected / 149 at risk

Adverse event: Major Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 79 affected / 149 at risk

Adverse event: Neurological Dysfunction
Serious: yes
Organ System: Nervous system disorders
Frequency: 25 affected / 149 at risk

Adverse event: Pericardial Fluid Collection
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 149 at risk

Adverse event: Psychiatric Episode
Serious: yes
Organ System: Psychiatric disorders
Frequency: 10 affected / 149 at risk

Adverse event: Renal Dysfunction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 17 affected / 149 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 36 affected / 149 at risk

Adverse event: Right ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 35 affected / 149 at risk

Adverse event: Arterial Non-CNS Thromboembolism
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 149 at risk

Adverse event: Embolism venous
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 149 at risk

Adverse event: Other Intermacs
Serious: yes
Organ System: General disorders
Frequency: 107 affected / 149 at risk

Adverse event: Major Bleeding
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 149 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 9 affected / 149 at risk

Adverse event: Device Malfunction/Failure
Serious: no
Organ System: Product Issues
Frequency: 5 affected / 149 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 149 at risk

Adverse event: Major Infection
Serious: no
Organ System: Infections and infestations
Frequency: 26 affected / 149 at risk

Adverse event: Psychiatric Episode
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 149 at risk

Adverse event: Right ventricular failure
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 149 at risk