Study: NCT00630253

Adverse event: Cerebral infarction
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 16 at risk

Adverse event: Elevaed ALT
Serious: no
Organ System: Investigations
Frequency: 2 affected / 16 at risk

Adverse event: Elevaed bilirubin
Serious: no
Organ System: Investigations
Frequency: 1 affected / 16 at risk

Adverse event: Transplant failure
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Haemolysis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Hepatitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 16 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 16 at risk

Adverse event: Neurotoxicity
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Pericardial effusion
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 16 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 9 at risk

Adverse event: Elevaed ALT
Serious: no
Organ System: Investigations
Frequency: 1 affected / 9 at risk

Adverse event: Elevaed bilirubin
Serious: no
Organ System: Investigations
Frequency: 1 affected / 9 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 9 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 9 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 9 at risk

Adverse event: Endotracheal intubation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Ototoxicity
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 9 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 9 at risk

Adverse event: Pneumonitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 9 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: hemorrhage in the upper GI tract
Frequency: 1 affected / 6 at risk

Adverse event: Cardiac arrect
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 6 at risk

Adverse event: Cardiopumonary shock
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 6 at risk

Adverse event: GI bleeding
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 6 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 6 at risk

Adverse event: Hypoxic ischemic encephalopathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 6 at risk

Adverse event: Endotracheal intubation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Liver Ischemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 6 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 6 at risk

Adverse event: Pulmonary haemorrhage
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Respiratory acidosis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Respiratory failure
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk