Study: NCT00660699

Adverse event: Abdominal cystic lesion
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: Cavitary lung lesion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 48 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 48 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 48 at risk

Adverse event: Oedema
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 48 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 48 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 48 at risk

Adverse event: Generalized weakness
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 48 at risk

Adverse event: Granulocytes
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 48 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 48 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 48 at risk

Adverse event: Hypomagnesaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 48 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 48 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 48 at risk

Adverse event: Ileus, GI
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 48 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 48 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 48 at risk

Adverse event: Platelets
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 48 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 48 at risk

Adverse event: Thrombosis/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 48 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 48 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 18 affected / 48 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 48 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 48 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 48 at risk

Adverse event: Ascites
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 48 at risk

Adverse event: Blood urea
Serious: no
Organ System: Investigations
Frequency: 2 affected / 48 at risk

Adverse event: Blood bilirubin
Serious: no
Organ System: Investigations
Frequency: 1 affected / 48 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 2 affected / 48 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 48 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 48 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 48 at risk

Adverse event: Dehydration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 48 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 48 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 48 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 48 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 48 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 48 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 3 affected / 48 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 48 at risk

Adverse event: Eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 48 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 34 affected / 48 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 48 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 48 at risk

Adverse event: Granulocytes
Serious: no
Organ System: Investigations
Frequency: 28 affected / 48 at risk

Adverse event: Hand/foot syndrome
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 48 at risk

Adverse event: Haematochezia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 48 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 32 affected / 48 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: General disorders
Frequency: 2 affected / 48 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 48 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 24 affected / 48 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 48 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 48 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 25 affected / 48 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 16 affected / 48 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 48 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 48 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 48 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 48 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 48 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 48 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 48 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 48 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Investigations
Frequency: 32 affected / 48 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 33 affected / 48 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 48 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 48 at risk

Adverse event: Nocturia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 48 at risk

Adverse event: Other neurologic
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 48 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 25 affected / 48 at risk

Adverse event: Phlebitis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 48 at risk

Adverse event: Platelets
Serious: no
Organ System: Investigations
Frequency: 24 affected / 48 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 48 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 48 at risk

Adverse event: SGOT/SGPT
Serious: no
Organ System: Investigations
Frequency: 26 affected / 48 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 48 at risk

Adverse event: Skin-photosensitivity
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 48 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 48 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 48 at risk

Adverse event: Thrombosis/embolism
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 48 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 48 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 48 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 48 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 48 at risk