Study: NCT01838863

Adverse event: Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 14 affected / 75 at risk

Adverse event: DVTs and PEs
Serious: yes
Organ System: Vascular disorders
Notes: Deep venous thrombosis (DVT), pulmonary embolism (PE) and pulmonary infarction (PI).
Frequency: 4 affected / 75 at risk

Adverse event: Acute kidney injury (AKI)
Serious: yes
Organ System: Renal and urinary disorders
Notes: Acute kidney injury (AKI), kidney failure and renal artery pseudoaneurysm.
Frequency: 5 affected / 75 at risk

Adverse event: Acute respiratory distress syndrome (ARDS)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Acute respiratory distress syndrome (ARDS) and lung failure
Frequency: 20 affected / 75 at risk

Adverse event: Hepatic failure
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Liver failure and bile duct leak
Frequency: 4 affected / 75 at risk

Adverse event: Cardiac
Serious: yes
Organ System: Cardiac disorders
Notes: Organ failure, atrial fibrillation and ventricular tachycardia
Frequency: 7 affected / 75 at risk

Adverse event: Adrenal insufficiency
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 75 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Gastrointestinal bleeding and abdominal compartment syndrome
Frequency: 2 affected / 75 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Pre-sacral hematoma
Frequency: 1 affected / 75 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Surgical and medical procedures
Notes: Delayed hemorrhage from surgical site and torn suture
Frequency: 2 affected / 75 at risk

Adverse event: Intensive Care Unit (ICU) delirium
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 75 at risk

Adverse event: Rhabdomyolysis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 75 at risk

Adverse event: Facial paralysis
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 75 at risk

Adverse event: Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 13 affected / 69 at risk

Adverse event: DVTs and PEs
Serious: yes
Organ System: Vascular disorders
Notes: Deep venous thrombosis (DVT), pulmonary embolism (PE) and pulmonary infarction (PI).
Frequency: 2 affected / 69 at risk

Adverse event: Acute kidney injury (AKI)
Serious: yes
Organ System: Renal and urinary disorders
Notes: Acute kidney injury (AKI), kidney failure and renal artery pseudoaneurysm.
Frequency: 6 affected / 69 at risk

Adverse event: Acute respiratory distress syndrome (ARDS)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Acute respiratory distress syndrome (ARDS) and lung failure
Frequency: 14 affected / 69 at risk

Adverse event: Hepatic failure
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Liver failure and bile duct leak
Frequency: 4 affected / 69 at risk

Adverse event: Cardiac
Serious: yes
Organ System: Cardiac disorders
Notes: Organ failure, atrial fibrillation and ventricular tachycardia
Frequency: 6 affected / 69 at risk

Adverse event: Intensive Care Unit (ICU) delirium
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 69 at risk