Study: NCT01332630

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 21 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 21 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 21 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 21 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 21 at risk

Adverse event: Oedema
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 21 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 21 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 21 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 21 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 2
Frequency: 3 affected / 21 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 2
Frequency: 3 affected / 21 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 3
Frequency: 1 affected / 21 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 2
Frequency: 2 affected / 21 at risk

Adverse event: Decreased ANC
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 2
Frequency: 7 affected / 21 at risk

Adverse event: Decreased ANC
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 3
Frequency: 2 affected / 21 at risk

Adverse event: Decreased Lymphocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 2
Frequency: 6 affected / 21 at risk

Adverse event: Decreased Lymphocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 3
Frequency: 2 affected / 21 at risk

Adverse event: Decreased WBC
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 2
Frequency: 3 affected / 21 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Grade 2
Frequency: 1 affected / 21 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Grade 3
Frequency: 1 affected / 21 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Nervous system disorders
Notes: Grade 2
Frequency: 1 affected / 21 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Nervous system disorders
Notes: Grade 3
Frequency: 2 affected / 21 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Nervous system disorders
Notes: Grade 2
Frequency: 1 affected / 21 at risk

Adverse event: Increased alk phos
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 2
Frequency: 1 affected / 21 at risk

Adverse event: increased AST
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 2
Frequency: 1 affected / 21 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: Cardiac disorders
Notes: Grade 2
Frequency: 1 affected / 21 at risk

Adverse event: Fatigue
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 2
Frequency: 10 affected / 21 at risk

Adverse event: Fatigue
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 3
Frequency: 5 affected / 21 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Immune system disorders
Notes: Grade 2
Frequency: 1 affected / 21 at risk

Adverse event: Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 3
Frequency: 2 affected / 21 at risk

Adverse event: Hand foot syndrone
Serious: no
Organ System: Immune system disorders
Notes: Grade 2
Frequency: 3 affected / 21 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Grade 3
Frequency: 1 affected / 21 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Notes: Grade 3
Frequency: 1 affected / 21 at risk

Adverse event: HTN
Serious: no
Organ System: Cardiac disorders
Notes: Grade 2
Frequency: 1 affected / 21 at risk

Adverse event: Hypoalbuninemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 2
Frequency: 1 affected / 21 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 2
Frequency: 1 affected / 21 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: Grade 2
Frequency: 1 affected / 21 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 2
Frequency: 2 affected / 21 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 2 affected / 21 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Notes: Grade 2
Frequency: 7 affected / 21 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Grade 2
Frequency: 5 affected / 21 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Grade 3
Frequency: 3 affected / 21 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Notes: Grade 2
Frequency: 1 affected / 21 at risk

Adverse event: Skin tissue disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 2
Frequency: 2 affected / 21 at risk

Adverse event: Syncope
Serious: no
Organ System: Cardiac disorders
Notes: Grade 3
Frequency: 1 affected / 21 at risk

Adverse event: Vulvovaginal candidiasis
Serious: no
Organ System: General disorders
Notes: Grade 2
Frequency: 1 affected / 21 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 1 affected / 21 at risk