Study: NCT01413100

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Notes: AE term from start of mobilization to day +100
Frequency: 1 affected / 20 at risk

Adverse event: Cardiac disorders
Serious: yes
Organ System: Cardiac disorders
Notes: cardiomyopathy, cardiac arrest. AE term from start of mobilization to day +100
Frequency: 1 affected / 20 at risk

Adverse event: Multi-system organ failure
Serious: yes
Organ System: General disorders
Notes: Multi-system organ failure. AE term from start of mobilization to day +100
Frequency: 1 affected / 20 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: AE term from start of mobilization to day +100
Frequency: 2 affected / 20 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: AE term from start of mobilization to day +100. No reportable AE's day + 101-365.
Frequency: 1 affected / 20 at risk

Adverse event: Ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: AE term from start of mobilization to day +100. No reportable AE's day + 101-365.
Frequency: 1 affected / 20 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Notes: AE term from start of mobilization to day +100. No reportable AE's day + 101-365.
Frequency: 1 affected / 20 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: AE term from start of mobilization to day +100. No reportable AE's day + 101-365.
Frequency: 2 affected / 20 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Notes: AE term from start of mobilization to day +100. No reportable AE's day + 101-365.
Frequency: 1 affected / 20 at risk

Adverse event: Pulmonary embolism
Serious: no
Organ System: Vascular disorders
Notes: AE term from start of mobilization to day +100. No reportable AE's day + 101-365.
Frequency: 1 affected / 20 at risk

Adverse event: Atelectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: AE term from start of mobilization to day +100. No reportable AE's day + 101-365.
Frequency: 1 affected / 20 at risk

Adverse event: Respiratory failure
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: AE term from start of mobilization to day +100. No reportable AE's day + 101-365.
Frequency: 3 affected / 20 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: AE term from start of mobilization to day +100. No reportable AE's day + 101-365.
Frequency: 1 affected / 20 at risk

Adverse event: Pulmonary oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: AE term from start of mobilization to day +100. No reportable AE's day + 101-365.
Frequency: 1 affected / 20 at risk

Adverse event: Acute Kidney Injury (AKI)
Serious: no
Organ System: Renal and urinary disorders
Notes: AE term from start of mobilization to day +100. No reportable AE's day + 101-365.
Frequency: 2 affected / 20 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Notes: AE term from start of mobilization to day +100. No reportable AE's day + 101-365.
Frequency: 1 affected / 20 at risk

Adverse event: neoplasm, benign
Serious: no
Organ System: General disorders
Notes: AE term from start of mobilization to day +100. No reportable AE's day + 101-365.
Frequency: 1 affected / 20 at risk

Adverse event: Cerebrovascular accident
Serious: no
Organ System: Nervous system disorders
Notes: AE term from start of mobilization to day +100. No reportable AE's day + 101-365.
Frequency: 1 affected / 20 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: AE term from start of mobilization to day +100. No reportable AE's day + 101-365.
Frequency: 3 affected / 20 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: AE term from start of mobilization to day +100. No reportable AE's day + 101-365.
Frequency: 1 affected / 20 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: AE term from start of mobilization to day +100. No reportable AE's day + 101-365.
Frequency: 1 affected / 20 at risk

Adverse event: Elevated GGT
Serious: no
Organ System: Investigations
Notes: AE term from start of mobilization to day +100. No reportable AE's day + 101-365.
Frequency: 1 affected / 20 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Immune system disorders
Notes: AE term from start of mobilization to day +100. No reportable AE's day + 101-365.
Frequency: 1 affected / 20 at risk

Adverse event: Gastric haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Notes: AE term from start of mobilization to day +100. No reportable AE's day + 101-365.
Frequency: 2 affected / 20 at risk

Adverse event: Ileus
Serious: no
Organ System: Gastrointestinal disorders
Notes: AE term from start of mobilization to day +100. No reportable AE's day + 101-365.
Frequency: 1 affected / 20 at risk

Adverse event: Ventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: AE term from start of mobilization to day +100. No reportable AE's day + 101-365.
Frequency: 2 affected / 20 at risk

Adverse event: cardiac arrhythmia's
Serious: no
Organ System: Cardiac disorders
Notes: AE term from start of mobilization to day +100. No reportable AE's day + 101-365.
Frequency: 1 affected / 20 at risk

Adverse event: Cardiomyopathy
Serious: no
Organ System: Cardiac disorders
Notes: AE term from start of mobilization to day +100. No reportable AE's day + 101-365.
Frequency: 1 affected / 20 at risk

Adverse event: Cytokine Rlease Syndrome
Serious: no
Organ System: Immune system disorders
Notes: AE term from start of mobilization to day +100. No reportable AE's day + 101-365.
Frequency: 1 affected / 20 at risk

Adverse event: Sepsis
Serious: no
Organ System: General disorders
Notes: AE term from start of mobilization to day +100. No reportable AE's day + 101-365.
Frequency: 1 affected / 20 at risk

Adverse event: Respiratory failure
Serious: no
Organ System: General disorders
Notes: AE term from start of mobilization to day +100. No reportable AE's day + 101-365.
Frequency: 1 affected / 20 at risk

Adverse event: Acute respiratory distress syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: AE term from start of mobilization to day +100. No reportable AE's day + 101-365.
Frequency: 1 affected / 20 at risk

Adverse event: Cardiomyopathy
Serious: no
Organ System: General disorders
Notes: AE term from start of mobilization to day +100. No reportable AE's day + 101-365.
Frequency: 1 affected / 20 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: General disorders
Notes: AE term from start of mobilization to day +100. No reportable AE's day + 101-365.
Frequency: 1 affected / 20 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Notes: AE term from start of mobilization to day +100. No reportable AE's day + 101-365.
Frequency: 1 affected / 20 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Notes: AE term from start of mobilization to day +100. No reportable AE's day + 101-365.
Frequency: 1 affected / 20 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: AE term from start of mobilization to day +100. No reportable AE's day + 101-365.
Frequency: 1 affected / 20 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: AE term from start of mobilization to day +100. No reportable AE's day + 101-365.
Frequency: 1 affected / 20 at risk

Adverse event: Acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: AE term from start of mobilization to day +100. No reportable AE's day + 101-365.
Frequency: 2 affected / 20 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: AE term from start of mobilization to day +100. No reportable AE's day + 101-365.
Frequency: 1 affected / 20 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: AE term from start of mobilization to day +100. No reportable AE's day + 101-365.
Frequency: 1 affected / 20 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: AE term from start of mobilization to day +100. No reportable AE's day + 101-365.
Frequency: 1 affected / 20 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: AE term from start of mobilization to day +100. No reportable AE's day + 101-365.
Frequency: 1 affected / 20 at risk

Adverse event: Pneumonitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: AE term from start of mobilization to day +100. No reportable AE's day + 101-365.
Frequency: 1 affected / 20 at risk

Adverse event: Renal aneurysm
Serious: no
Organ System: Vascular disorders
Notes: AE term from start of mobilization to day +100. No reportable AE's day + 101-365.
Frequency: 1 affected / 20 at risk