Study: NCT00546104

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 31 at risk

Adverse event: Pain, back
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 31 at risk

Adverse event: Pain, extrimity limb
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 31 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 31 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 31 at risk

Adverse event: Syncope
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 31 at risk

Adverse event: Edema, limb
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 31 at risk

Adverse event: Aspartate aminotransferase
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 31 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 31 at risk

Adverse event: Pain, chest/thorax
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 31 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 31 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 31 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 31 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: grade 1 19% grade 2 13% grade 3 10%
Frequency: 13 affected / 31 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: number of subject effected: Grade 1=7 grade 2=8 grade 3=1
Frequency: 16 affected / 31 at risk

Adverse event: fever: non-neutropenic
Serious: no
Organ System: Gastrointestinal disorders
Notes: number of subjects effected: Grade 1=3 grade 2=2 grade 3=0
Frequency: 5 affected / 31 at risk

Adverse event: Flushing
Serious: no
Organ System: General disorders
Notes: number of subjects effected: Grade 1=5 grade 2=2 grade 3=0
Frequency: 7 affected / 31 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Notes: number of subjects effected: Grade 1=6 grade 2=2 grade 3=0
Frequency: 8 affected / 31 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: number of subjects effected: Grade 1=10 grade 2=5 grade 3=0
Frequency: 15 affected / 31 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: number of subjects effected: Grade 1=8 grade 2=3 grade 3=0
Frequency: 11 affected / 31 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: number of subjects effected: Grade 1=10 grade 2=8 grade 3=1
Frequency: 19 affected / 31 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: number of subjects effected: Grade 1=10 grade 2=3 grade 3=0
Frequency: 13 affected / 31 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: number of subjects effected: Grade 1=6 grade 2=0 grade 3=0
Frequency: 6 affected / 31 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: number of subjects effected: Grade 1=4 grade 2=5 grade 3=3
Frequency: 12 affected / 31 at risk

Adverse event: Pneumonitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: number of subjects effected: Grade 1=0 grade 2=1 grade 3=2
Frequency: 3 affected / 31 at risk

Adverse event: paricardial effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: number of subjects effected: Grade 1=2 grade 2=0 grade 3=0
Frequency: 2 affected / 31 at risk

Adverse event: pain: abdomen
Serious: no
Organ System: Gastrointestinal disorders
Notes: number of subjects effected: Grade 1=6 grade 2=0 grade 3=0
Frequency: 6 affected / 31 at risk

Adverse event: pain: bone
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: number of subjects effected: Grade 1=5 grade 2=0 grade 3=1
Frequency: 6 affected / 31 at risk

Adverse event: pain: chestwall
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: number of subjects effected: Grade 1=2 grade 2=2 grade 3=0
Frequency: 4 affected / 31 at risk

Adverse event: pain:extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: number of subjects effected: Grade 1=3 grade 2=2 grade 3=1
Frequency: 6 affected / 31 at risk

Adverse event: pain: headache
Serious: no
Organ System: Nervous system disorders
Notes: number of subjects effected: Grade 1=9 grade 2=2 grade 3=0
Frequency: 11 affected / 31 at risk

Adverse event: pain:joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: number of subjects effected: Grade 1=4 grade 2=3 grade 3=2
Frequency: 9 affected / 31 at risk

Adverse event: pain: muscle
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: number of subjects effected: Grade 1=1 grade 2=3 grade 3=0
Frequency: 4 affected / 31 at risk

Adverse event: elevated ALT
Serious: no
Organ System: Hepatobiliary disorders
Notes: number of subjects effected: Grade 1=4 grade 2=1 grade 3=0
Frequency: 5 affected / 31 at risk

Adverse event: elevated AST
Serious: no
Organ System: Hepatobiliary disorders
Notes: number of subjects effected: Grade 1=2 grade 2=0 grade 3=0
Frequency: 4 affected / 31 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Investigations
Notes: number of subjects effected: Grade 1=1 grade 2=0 grade 3=1
Frequency: 2 affected / 31 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Investigations
Notes: number of subjects effected: Grade 1=0 grade 2=1 grade 3=1
Frequency: 2 affected / 31 at risk

Adverse event: Deep vein thrombosis
Serious: no
Organ System: Vascular disorders
Notes: number of subjects effected: Grade 1=0 grade 2=0 grade 3=2
Frequency: 2 affected / 31 at risk

Adverse event: edema:facial
Serious: no
Organ System: General disorders
Notes: number of subjects effected: Grade 1=4 grade 2=1 grade 3=0
Frequency: 5 affected / 31 at risk

Adverse event: edema: extremity
Serious: no
Organ System: General disorders
Notes: number of subjects effected: Grade 1=5 grade 2=1 grade 3=0
Frequency: 6 affected / 31 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: number of subjects effected: Grade 1=0 grade 2=0 grade 3=1
Frequency: 1 affected / 31 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: number of subjects effected: Grade 1=14 grade 2=2 grade 3=0
Frequency: 16 affected / 31 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: number of subjects effected: Grade 1=4 grade 2=0 grade 3=0
Frequency: 4 affected / 31 at risk

Adverse event: Rhinitis
Serious: no
Organ System: General disorders
Notes: number of subjects effected: Grade 1=5 grade 2=0 grade 3=0
Frequency: 5 affected / 31 at risk

Adverse event: neuropathy sensory
Serious: no
Organ System: Nervous system disorders
Notes: number of subjects effected: Grade 1=7 grade 2=2 grade 3=0
Frequency: 9 affected / 31 at risk

Adverse event: plueral effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: number of subjects effected: Grade 1=5 grade 2=8 grade 3=3
Frequency: 16 affected / 31 at risk