Study: NCT00334074

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 30 at risk

Adverse event: Edema/Weight Gain
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 30 at risk

Adverse event: Elevated LFT
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 30 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 30 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 30 at risk

Adverse event: Fungal Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 30 at risk

Adverse event: Palmar-plantar erythrodysaesthesia syndrome
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 30 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 30 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pancytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 24 affected / 30 at risk

Adverse event: Platelet Allosensitization
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: 1
Frequency: 1 affected / 30 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 30 at risk

Adverse event: Small Bowell Obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Staph Bacteremia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Staph epidermitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Hypervolaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Bilateral External Otitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Delirium
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 30 at risk

Adverse event: Multiple System Organ Failure
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 30 at risk

Adverse event: Perianal Abcess
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pulmonary Infiltrate
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Renal Insufficiency / Failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 30 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 30 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 30 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 30 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 30 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 30 at risk

Adverse event: Edema/Weight Gain
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 30 at risk