Study: NCT00590187

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 40 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 16 affected / 40 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 40 at risk

Adverse event: Throbocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 24 affected / 40 at risk

Adverse event: Atrial fibrilation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 40 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 40 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 40 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 40 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Hyperbilirubinaemia
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 40 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 40 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 40 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 40 at risk

Adverse event: Sepsis
Serious: yes
Organ System: General disorders
Frequency: 9 affected / 40 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 40 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Back pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 40 at risk

Adverse event: Musculoskeletal chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Insomnia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 40 at risk

Adverse event: Ecchymosis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Petechiae
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 40 at risk

Adverse event: Hypotension
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 40 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 40 at risk

Adverse event: Atrial fibrilation
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 40 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Frequency: 6 affected / 40 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 40 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 40 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 16 affected / 40 at risk

Adverse event: Stomatitis
Serious: no
Organ System: General disorders
Frequency: 4 affected / 40 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 12 affected / 40 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 19 affected / 40 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 5 affected / 40 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 40 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 40 at risk

Adverse event: Bacteraemia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 40 at risk

Adverse event: Cellulitis
Serious: no
Organ System: General disorders
Frequency: 3 affected / 40 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 9 affected / 40 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 3 affected / 40 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 40 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 7 affected / 40 at risk

Adverse event: Back pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 40 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: General disorders
Frequency: 7 affected / 40 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 7 affected / 40 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 7 affected / 40 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 40 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 40 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: General disorders
Frequency: 15 affected / 40 at risk

Adverse event: Epistaxis
Serious: no
Organ System: General disorders
Frequency: 6 affected / 40 at risk

Adverse event: Ecchymosis
Serious: no
Organ System: General disorders
Frequency: 4 affected / 40 at risk

Adverse event: Petechiae
Serious: no
Organ System: General disorders
Frequency: 4 affected / 40 at risk

Adverse event: Alopecia
Serious: no
Organ System: General disorders
Frequency: 7 affected / 40 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 40 at risk

Adverse event: Hypotension
Serious: no
Organ System: General disorders
Frequency: 4 affected / 40 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 20 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 20 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 20 at risk

Adverse event: Throbocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 20 at risk

Adverse event: Atrial fibrilation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 20 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 20 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Hyperbilirubinaemia
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 20 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 20 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 20 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 20 at risk

Adverse event: Sepsis
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 20 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 20 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Ecchymosis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Atrial fibrilation
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 20 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 20 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 20 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 20 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 6 affected / 20 at risk

Adverse event: Stomatitis
Serious: no
Organ System: General disorders
Frequency: 2 affected / 20 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 5 affected / 20 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 10 affected / 20 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 8 affected / 20 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 20 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Bacteraemia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 5 affected / 20 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 4 affected / 20 at risk

Adverse event: Back pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 3 affected / 20 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 20 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: General disorders
Frequency: 2 affected / 20 at risk

Adverse event: Epistaxis
Serious: no
Organ System: General disorders
Frequency: 3 affected / 20 at risk

Adverse event: Ecchymosis
Serious: no
Organ System: General disorders
Frequency: 3 affected / 20 at risk

Adverse event: Petechiae
Serious: no
Organ System: General disorders
Frequency: 3 affected / 20 at risk

Adverse event: Alopecia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 20 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 45 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 22 affected / 45 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 45 at risk

Adverse event: Throbocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 22 affected / 45 at risk

Adverse event: Atrial fibrilation
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 45 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 45 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 45 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 45 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 45 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 45 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 45 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 45 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 45 at risk

Adverse event: Sepsis
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 45 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 45 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 45 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 45 at risk

Adverse event: Musculoskeletal chest pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 45 at risk

Adverse event: Headache
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 45 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 45 at risk

Adverse event: Ecchymosis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 45 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 45 at risk

Adverse event: Hypotension
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 45 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 45 at risk

Adverse event: Atrial fibrilation
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 45 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 45 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 45 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 45 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 23 affected / 45 at risk

Adverse event: Stomatitis
Serious: no
Organ System: General disorders
Frequency: 7 affected / 45 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 11 affected / 45 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 13 affected / 45 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 15 affected / 45 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 9 affected / 45 at risk

Adverse event: Cellulitis
Serious: no
Organ System: General disorders
Frequency: 3 affected / 45 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 8 affected / 45 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 3 affected / 45 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 45 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 45 at risk

Adverse event: Back pain
Serious: no
Organ System: General disorders
Frequency: 6 affected / 45 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: General disorders
Frequency: 6 affected / 45 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: General disorders
Frequency: 8 affected / 45 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 10 affected / 45 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 6 affected / 45 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 7 affected / 45 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 45 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: General disorders
Frequency: 10 affected / 45 at risk

Adverse event: Epistaxis
Serious: no
Organ System: General disorders
Frequency: 5 affected / 45 at risk

Adverse event: Ecchymosis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 45 at risk

Adverse event: Petechiae
Serious: no
Organ System: General disorders
Frequency: 7 affected / 45 at risk

Adverse event: Alopecia
Serious: no
Organ System: General disorders
Frequency: 10 affected / 45 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 45 at risk

Adverse event: Hypotension
Serious: no
Organ System: General disorders
Frequency: 3 affected / 45 at risk