Study: NCT00088218

Adverse event: Gastrointestinal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 16 at risk

Adverse event: Adult Respiratiory Distress Syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 16 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 16 at risk

Adverse event: Prolonged Myelosuppression
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Sepsis Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Fungal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 16 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 16 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 16 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 10 affected / 16 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 16 at risk

Adverse event: Elevated alanine aminotransferase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 10 affected / 16 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 16 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 16 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 16 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 6 affected / 16 at risk

Adverse event: Elevated aspartate transaminase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 5 affected / 16 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 16 at risk

Adverse event: Elevated alkaline phosphatase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 16 at risk

Adverse event: Elevated Creatinine
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 16 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 16 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 16 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 16 at risk

Adverse event: Hand-Foot syndrome
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 16 at risk

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

Adverse event: Puritis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 16 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 79 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 79 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 79 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 6 affected / 79 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 79 at risk

Adverse event: Prolonged Myelosuppression
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 79 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 79 at risk

Adverse event: Staphylococcus Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 79 at risk

Adverse event: Sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 79 at risk

Adverse event: Elevated Triponin
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 79 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 79 at risk

Adverse event: Syncope
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 79 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 79 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 79 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 79 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 79 at risk

Adverse event: Secondary Malignancy Colon Cancer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 79 at risk

Adverse event: Bactremia Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 79 at risk

Adverse event: Secondary Malignancy Squamous Cell Carcinoma
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 79 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 79 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 79 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 48 affected / 79 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 39 affected / 79 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 49 affected / 79 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 79 at risk

Adverse event: Elevated alanine aminotransferase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 35 affected / 79 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 37 affected / 79 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 27 affected / 79 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 79 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 29 affected / 79 at risk

Adverse event: Elevated aspartate transaminase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 25 affected / 79 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 79 at risk

Adverse event: Elevated alkaline phosphatase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 15 affected / 79 at risk

Adverse event: Elevated Creatinine
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 79 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 79 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 9 affected / 79 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 79 at risk

Adverse event: Hand-Foot syndrome
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 79 at risk

Adverse event: Flushing
Serious: no
Organ System: General disorders
Frequency: 6 affected / 79 at risk

Adverse event: Puritis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 79 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 79 at risk