Study: NCT00026221

Adverse event: Thrombolembolic event
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 16 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 3
Frequency: 1 affected / 16 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 3
Frequency: 1 affected / 16 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Grade 3
Frequency: 2 affected / 16 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: Grade 3
Frequency: 1 affected / 16 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 3
Frequency: 1 affected / 16 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: Grade 3
Frequency: 3 affected / 16 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Grade 3
Frequency: 5 affected / 16 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Notes: Grade 3
Frequency: 1 affected / 16 at risk

Adverse event: Thrombolembolic event
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 16 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 3
Frequency: 2 affected / 16 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 3
Frequency: 1 affected / 16 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Grade 3
Frequency: 3 affected / 16 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Grade 3
Frequency: 1 affected / 16 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: Grade 3
Frequency: 3 affected / 16 at risk

Adverse event: Mental status changes
Serious: no
Organ System: Nervous system disorders
Notes: Grade 3
Frequency: 1 affected / 16 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Grade 3
Frequency: 4 affected / 16 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Notes: Grade 3
Frequency: 1 affected / 16 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 25 at risk

Adverse event: Elevated Troponin level
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 25 at risk

Adverse event: Pulmonary Emboli
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 3
Frequency: 2 affected / 25 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Grade 3
Frequency: 3 affected / 25 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Grade 3
Frequency: 1 affected / 25 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 3
Frequency: 3 affected / 25 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Notes: Grade 3
Frequency: 3 affected / 25 at risk

Adverse event: Thrombosis/embolism
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 3 and 4
Frequency: 2 affected / 25 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 3 and 4
Frequency: 2 affected / 25 at risk

Adverse event: Confusion/Memory loss
Serious: no
Organ System: Psychiatric disorders
Notes: Grade 3 and 4
Frequency: 3 affected / 25 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 3 and 4
Frequency: 3 affected / 25 at risk

Adverse event: Neutropenia
Serious: no
Organ System: General disorders
Notes: Grade 3 or 4
Frequency: 5 affected / 25 at risk

Adverse event: AST/ALT
Serious: no
Organ System: Investigations
Notes: Grade 3 and 4
Frequency: 2 affected / 25 at risk

Adverse event: Abdominal pain/cramping
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 3 and 4
Frequency: 2 affected / 25 at risk