Study: NCT00361231

Adverse event: Grade 4 Dyspnea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: unlikely related
Frequency: 1 affected / 35 at risk

Adverse event: Grade 4 confusion
Serious: yes
Organ System: Nervous system disorders
Notes: unrelated
Frequency: 2 affected / 35 at risk

Adverse event: Grade 3 Bilirubin
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 35 at risk

Adverse event: Death within 30 days
Serious: yes
Organ System: General disorders
Notes: Unrelated
Frequency: 1 affected / 35 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Grade 4 Cognitive disturbance
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 35 at risk

Adverse event: Grade 4 Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Neutrophil count
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Probably related
Frequency: 2 affected / 35 at risk

Adverse event: Grade 4 Hypophosphatemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: (unlikely related)
Frequency: 1 affected / 35 at risk

Adverse event: Grade 4 lymphopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: probably related
Frequency: 1 affected / 35 at risk

Adverse event: Grade 4 fatigue
Serious: yes
Organ System: General disorders
Notes: possibly related
Frequency: 2 affected / 35 at risk

Adverse event: Grade 3 Wound dehiscence
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 35 at risk

Adverse event: Grade 3 infection, wound
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 35 at risk

Adverse event: Grade 3 Hypoxia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 35 at risk

Adverse event: Grade 3 abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: unrelated
Frequency: 1 affected / 35 at risk

Adverse event: Grade 4 Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: unlikely related
Frequency: 1 affected / 35 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: possibly related
Frequency: 1 affected / 35 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 24 affected / 35 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 21 affected / 35 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 26 affected / 35 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 26 affected / 35 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 35 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 29 affected / 35 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 28 affected / 35 at risk

Adverse event: Raised AST
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 28 affected / 35 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 35 at risk

Adverse event: Raised ALT
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 35 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 35 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 20 affected / 35 at risk

Adverse event: Raised Alkaline phosphatase
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 35 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 35 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 35 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 12 affected / 35 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 35 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 35 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 35 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 35 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 35 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 35 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 35 at risk

Adverse event: Acne rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 35 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 35 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 6 affected / 35 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 35 at risk

Adverse event: Epistaxis
Serious: no
Organ System: General disorders
Frequency: 16 affected / 35 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 15 affected / 35 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 35 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 35 at risk