Study: NCT00351039

Adverse event: Syncope
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Causality: Unlikely
Frequency: 1 affected / 8 at risk

Adverse event: Non Febrile Neutropenia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Causality: Definitely Related
Frequency: 2 affected / 8 at risk

Adverse event: Fatigue
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Causality: 2 Definitely Related, 1 Probably Related
Frequency: 3 affected / 8 at risk

Adverse event: Dyspnea with exertion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Causality: Definitely Related
Frequency: 1 affected / 8 at risk

Adverse event: Proteinuria
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Causality: Probably Related
Frequency: 1 affected / 8 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Causality: Possibly Related
Frequency: 1 affected / 8 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Causality: Unrelated
Frequency: 1 affected / 8 at risk

Adverse event: Pain, Penis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Causality: Unrelated
Frequency: 1 affected / 8 at risk

Adverse event: Secondary Malignancy (bladder tumor)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Causality: Unrelated
Frequency: 1 affected / 8 at risk

Adverse event: Right Hip Pain
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Causality: Unrelated
Frequency: 1 affected / 8 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Causality: Probably Related
Frequency: 1 affected / 8 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Causality: Probably Related
Frequency: 1 affected / 8 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Causality: Probably Related
Frequency: 1 affected / 8 at risk

Adverse event: Pruritus
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Causality: Probably Related
Frequency: 1 affected / 8 at risk

Adverse event: Fatigue
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Causality: 1 Definitely Related, 1 Probably Related, 1 Unrelated
Frequency: 3 affected / 8 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Causality: 1 Probably Related, 1 Possibly Related
Frequency: 2 affected / 8 at risk

Adverse event: Anaemia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Causality: 1 Definitely Related, 1 Unlikely
Frequency: 2 affected / 8 at risk

Adverse event: Generalized Weakness
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Causality: Definitely Related
Frequency: 1 affected / 8 at risk

Adverse event: Nausea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Causality: Probably Related
Frequency: 1 affected / 8 at risk

Adverse event: Vomiting
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Causality: Probably Related
Frequency: 1 affected / 8 at risk

Adverse event: Aphasia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Causality: Unlikely
Frequency: 1 affected / 8 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Causality: Probably Related
Frequency: 1 affected / 8 at risk

Adverse event: Serum Creatinine Elevation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Causality: Probably Related
Frequency: 1 affected / 8 at risk

Adverse event: ALT Elevation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Causality: Probably Related
Frequency: 1 affected / 8 at risk

Adverse event: Non Febrile Neutropenia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Causality: Probably Related
Frequency: 1 affected / 8 at risk

Adverse event: Bilateral Lower Extremity Weakness
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Causality: Unlikely
Frequency: 1 affected / 8 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Causality: Probably Related
Frequency: 1 affected / 8 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Causality: Unrelated
Frequency: 1 affected / 8 at risk

Adverse event: Pain, Left Axillary Area
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Causality: Unrelated
Frequency: 1 affected / 8 at risk

Adverse event: Pain, Back
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Causality: Unrelated
Frequency: 1 affected / 8 at risk

Adverse event: Constipation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Causality: Unrelated
Frequency: 1 affected / 8 at risk

Adverse event: Left Hip Pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Causality: Unrelated
Frequency: 1 affected / 8 at risk

Adverse event: Gingivitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Causality: Unrelated
Frequency: 1 affected / 8 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Causality:Probably Related
Frequency: 1 affected / 8 at risk

Adverse event: Rash-Acneiform
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Causality: Definitely Related
Frequency: 1 affected / 8 at risk

Adverse event: Fungal infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Causality: Unrelated
Frequency: 1 affected / 8 at risk