Study: NCT00551525

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 60 at risk

Adverse event: Neutrophil count decreased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 60 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 60 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 60 at risk

Adverse event: Blood disorder
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 60 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 25 affected / 60 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 60 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 60 at risk

Adverse event: Gastrointestinal disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 60 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 60 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 60 at risk

Adverse event: Proctitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 60 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 30 affected / 60 at risk

Adverse event: Pain [other]
Serious: no
Organ System: General disorders
Frequency: 3 affected / 60 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 60 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Investigations
Frequency: 39 affected / 60 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 11 affected / 60 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 26 affected / 60 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 46 affected / 60 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 60 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 60 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 60 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 60 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 26 affected / 60 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 16 affected / 60 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 60 at risk

Adverse event: Urogenital disorder
Serious: no
Organ System: Renal and urinary disorders
Frequency: 10 affected / 60 at risk

Adverse event: Erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 7 affected / 60 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 60 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 10 affected / 60 at risk