Study: NCT00838929

Adverse event: Increase in amylase
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Oral pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Ulceration - Grade 2
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 7 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 7 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 7 at risk

Adverse event: Ulceration - Grade 3
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Oral pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Ataxia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Activated partial thromboplastin time prolonged
Serious: no
Organ System: Investigations
Frequency: 1 affected / 7 at risk

Adverse event: Increased blood alkaline phosphatase
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Low hemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 7 at risk

Adverse event: Prothrombin time prolonged
Serious: no
Organ System: Investigations
Frequency: 1 affected / 7 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Cystitis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Death
Serious: yes
Organ System: Nervous system disorders
Notes: Disease progession
Frequency: 2 affected / 6 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 6 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 6 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Low hemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 6 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Increased alanine aminotransferase
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Constipation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 6 at risk

Adverse event: Alopecia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Low sodium
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Hypermagnesaemia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk