Study: NCT00556452

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 46 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 46 at risk

Adverse event: Hypoxia/Dyspnea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 46 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 46 at risk

Adverse event: Bone pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 46 at risk

Adverse event: Vascular access complication
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 46 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 46 at risk

Adverse event: Atrial Fibrilation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 46 at risk

Adverse event: Bladder Hemmorhage
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 46 at risk

Adverse event: Blood disorder
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 46 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 46 at risk

Adverse event: Disease progression
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 46 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 46 at risk

Adverse event: Oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Graft versus host disease
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 46 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 46 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 46 at risk

Adverse event: Portal hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 46 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 46 at risk

Adverse event: Transaminitis*
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 43 affected / 46 at risk

Adverse event: Hyperbilirubiniemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 8 affected / 46 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 31 affected / 46 at risk

Adverse event: Nausea/Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 46 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 46 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 46 at risk

Adverse event: Creatinine elevation
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 46 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 46 at risk

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 46 at risk

Adverse event: Hand-foot syndrome
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 46 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 46 at risk

Adverse event: Hypotention
Serious: no
Organ System: General disorders
Frequency: 2 affected / 46 at risk

Adverse event: Veno-Occlusive Disease
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 46 at risk

Adverse event: Ascites
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 46 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 46 at risk

Adverse event: Hemorragic Cystitis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 46 at risk

Adverse event: Arrythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 46 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: General disorders
Frequency: 1 affected / 46 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 46 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 46 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 46 at risk

Adverse event: Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 46 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 21 affected / 46 at risk

Adverse event: Deep vein thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 46 at risk

Adverse event: Cholycytitis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 46 at risk

Adverse event: Cirrhosis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 46 at risk

Adverse event: Siezure
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 46 at risk