Study: NCT00588523

Adverse event: Abdominal cramping
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 60 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Blood bilirubin
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 60 at risk

Adverse event: CNS Hemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 60 at risk

Adverse event: CNS Necrosis/cystic progression
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 60 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 60 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 60 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 60 at risk

Adverse event: Delusion
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 60 at risk

Adverse event: Derm, skin other
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 60 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 60 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 60 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 60 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 60 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Gastrointestinal, other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 60 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 60 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 60 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 60 at risk

Adverse event: Infection unk ANC
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 60 at risk

Adverse event: Infection w/out neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 60 at risk

Adverse event: Insomnia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 60 at risk

Adverse event: White blood cell count
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 60 at risk

Adverse event: Liver dysfunction/failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 60 at risk

Adverse event: Mood alteration/anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 60 at risk

Adverse event: Muscle weakness - whole body/general
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 60 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 60 at risk

Adverse event: Neurology, other
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 60 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 60 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 60 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Platelets
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 60 at risk

Adverse event: Rash, dequamation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 60 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 60 at risk

Adverse event: Veno-Occlusive Disease
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 60 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 60 at risk

Adverse event: Platelets
Serious: no
Organ System: Investigations
Frequency: 16 affected / 60 at risk

Adverse event: Leukocytes
Serious: no
Organ System: Investigations
Frequency: 16 affected / 60 at risk

Adverse event: Neutrophil count
Serious: no
Organ System: Investigations
Frequency: 13 affected / 60 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 12 affected / 60 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Investigations
Frequency: 10 affected / 60 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 60 at risk

Adverse event: Platelets
Serious: no
Organ System: Investigations
Frequency: 8 affected / 60 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 60 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 6 affected / 60 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 60 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 60 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 60 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 60 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 4 affected / 60 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 60 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 4 affected / 60 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 60 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 60 at risk

Adverse event: AST, SGOT
Serious: no
Organ System: Investigations
Frequency: 3 affected / 60 at risk

Adverse event: Abdominal pain/cramping
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 60 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 60 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 60 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 60 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 60 at risk

Adverse event: Pain - other
Serious: no
Organ System: General disorders
Frequency: 3 affected / 60 at risk