Study: NCT02389894

Adverse event: Acute Kidney Injury - Stage 1
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 133 at risk

Adverse event: Acute Kidney Injury - Stage 2
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 133 at risk

Adverse event: Acute Kidney Injury - Stage 3
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 7 affected / 133 at risk

Adverse event: Bleeding - Re-operation for hemorrhage or tamponade
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 133 at risk

Adverse event: Cardiac Arrhythmias - Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 133 at risk

Adverse event: Cardiac Arrhythmias - Sustained ventricular arrhythmia requiring defibrillation or cardioversion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 133 at risk

Adverse event: Cardiac Arrhythmias - Sustained supraventricular arrhythmia requiring drug treatment or cardioversio
Serious: yes
Organ System: Cardiac disorders
Frequency: 42 affected / 133 at risk

Adverse event: Cardiac Arrhythmias - Cardiac conduction abnormalities or sustained bradycardia requiring permanent
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 133 at risk

Adverse event: Pericardial Fluid Collection
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 133 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 133 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 133 at risk

Adverse event: Hepatic Dysfunction (Liver injury and Impaired Liver function)
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 133 at risk

Adverse event: Major Infection - Localized Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 13 affected / 133 at risk

Adverse event: Major Infection - Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 133 at risk

Adverse event: Myocardial Infarction - Non-Procedure Related
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 133 at risk

Adverse event: Myocardial Infarction - Peri-CABG
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 133 at risk

Adverse event: Neurological Dysfunction- Ischemic Stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 133 at risk

Adverse event: Neurological Dysfunction- Toxic Metabolic Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 133 at risk

Adverse event: Neurological Dysfunction- Other Neurological Dysfunction*
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 133 at risk

Adverse event: Renal Events (Renal Failure)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 133 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 133 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 133 at risk

Adverse event: Venous Thromboembolism Event - Deep Vein Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 133 at risk

Adverse event: Venous Thromboembolism Event - Other*
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 133 at risk

Adverse event: Wound dehiscence
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 133 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 133 at risk

Adverse event: Aortic Valve Re-operation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 133 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 133 at risk

Adverse event: Disseminated intravascular coagulation
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 133 at risk

Adverse event: Hypervolaemia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 133 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 133 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 133 at risk

Adverse event: Orthostatic hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 133 at risk

Adverse event: Pneumoperitoneum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 133 at risk

Adverse event: Repair of Aorta
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 133 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 133 at risk

Adverse event: Small bowel obstruction/ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 133 at risk

Adverse event: Syncope
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 133 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 133 at risk

Adverse event: Acute Kidney Injury - Stage 1
Serious: no
Organ System: Renal and urinary disorders
Frequency: 21 affected / 133 at risk

Adverse event: Cardiac Arrhythmias - Sustained supraventricular arrhythmia requiring drug treatment or cardioversio
Serious: no
Organ System: Cardiac disorders
Frequency: 23 affected / 133 at risk

Adverse event: Major Infection - Localized Infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 133 at risk

Adverse event: Acute Kidney Injury - Stage 1
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 118 at risk

Adverse event: Acute Kidney Injury - Stage 3
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 118 at risk

Adverse event: Bleeding - Transfusion > 5 units RBC <24 hours following surgery
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 118 at risk

Adverse event: Bleeding - Re-operation for hemorrhage or tamponade
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 118 at risk

Adverse event: Cardiac Arrhythmias - Sustained supraventricular arrhythmia requiring drug treatment or cardioversio
Serious: yes
Organ System: Cardiac disorders
Frequency: 22 affected / 118 at risk

Adverse event: Cardiac Arrhythmias - Cardiac conduction abnormalities or sustained bradycardia requiring permanent
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 118 at risk

Adverse event: Pericardial Fluid Collection
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 118 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 118 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 118 at risk

Adverse event: Hepatic Dysfunction (Liver injury and Impaired Liver function)
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 118 at risk

Adverse event: Major Infection - Localized Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 118 at risk

Adverse event: Major Infection - Endocarditis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 118 at risk

Adverse event: Major Infection - Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 118 at risk

Adverse event: Neurological Dysfunction- Ischemic Stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 118 at risk

Adverse event: Neurological Dysfunction- Toxic Metabolic Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 118 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 118 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 118 at risk

Adverse event: Venous Thromboembolism Event - Pulmonary Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 118 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 118 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 118 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 118 at risk

Adverse event: Haemothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 118 at risk

Adverse event: Pulmonary mass
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 118 at risk

Adverse event: Post-pericardiotomy Syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 118 at risk

Adverse event: Syncope
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 118 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 118 at risk

Adverse event: Acute Kidney Injury - Stage 1
Serious: no
Organ System: Renal and urinary disorders
Frequency: 13 affected / 118 at risk

Adverse event: Cardiac Arrhythmias - Sustained supraventricular arrhythmia requiring drug treatment or cardioversio
Serious: no
Organ System: Cardiac disorders
Frequency: 34 affected / 118 at risk

Adverse event: Major Infection - Localized Infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 118 at risk

Adverse event: Acute Kidney Injury - Stage 2
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 132 at risk

Adverse event: Acute Kidney Injury - Stage 3
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 132 at risk

Adverse event: Bleeding - Transfusion > 5 units RBC <24 hours following surgery
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 132 at risk

Adverse event: Bleeding - Re-operation for hemorrhage or tamponade
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 132 at risk

Adverse event: Cardiac Arrhythmias - Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 132 at risk

Adverse event: Cardiac Arrhythmias - Sustained supraventricular arrhythmia requiring drug treatment or cardioversio
Serious: yes
Organ System: Cardiac disorders
Frequency: 25 affected / 132 at risk

Adverse event: Cardiac Arrhythmias - Cardiac conduction abnormalities or sustained bradycardia requiring permanent
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 132 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 132 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 132 at risk

Adverse event: Major Infection - Localized Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 10 affected / 132 at risk

Adverse event: Major Infection - Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 132 at risk

Adverse event: Neurological Dysfunction- Transient Ischemic Attack - TIA
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 132 at risk

Adverse event: Neurological Dysfunction- Ischemic Stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 132 at risk

Adverse event: Neurological Dysfunction- Toxic Metabolic Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 132 at risk

Adverse event: Neurological Dysfunction- Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 132 at risk

Adverse event: Neurological Dysfunction- Other Neurological Dysfunction*
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 132 at risk

Adverse event: Renal Events (Renal Failure)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 132 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 132 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 132 at risk

Adverse event: Venous Thromboembolism Event - Deep Vein Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 132 at risk

Adverse event: Adrenal insufficiency
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 132 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 132 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 132 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 132 at risk

Adverse event: Dysphagia with PEG tube placement
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 132 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 132 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 132 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 132 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 132 at risk

Adverse event: Hypercapnia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 132 at risk

Adverse event: Intra abdominal bleeding
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 132 at risk

Adverse event: Severe TR requiring TV replacement
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 132 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 132 at risk

Adverse event: Small bowel obstruction/ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 132 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 132 at risk

Adverse event: Acute Kidney Injury - Stage 1
Serious: no
Organ System: Renal and urinary disorders
Frequency: 21 affected / 132 at risk

Adverse event: Cardiac Arrhythmias - Sustained supraventricular arrhythmia requiring drug treatment or cardioversio
Serious: no
Organ System: Cardiac disorders
Frequency: 24 affected / 132 at risk

Adverse event: Major Infection - Localized Infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 132 at risk