Study: NCT00570700

Adverse event: Fatigue/asthenia
Serious: yes
Organ System: General disorders
Notes: Grade 3 Fatigue/asthenia in 5 (19%) of subjects.
Frequency: 5 affected / 38 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3 Diarrhea occurred in 2 (8%) of subjects.
Frequency: 2 affected / 38 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 3 Dyspnea occurred in 2 (8%) subjects.
Frequency: 2 affected / 38 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3 GI bleed occurred in 2 (8%) subjects.
Frequency: 2 affected / 38 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: 1 (4%) Grade 3 and 1 (4%) Grade 4 Hyponatremia event occurred.
Frequency: 2 affected / 38 at risk

Adverse event: Elevated lipase
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 3 Elevated lipase occurred in 1 (4) subject.
Frequency: 1 affected / 38 at risk

Adverse event: Pleural / pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Notes: Grade 3 Pleural / pericardial effusion occurred in 1 (4%) subject.
Frequency: 1 affected / 38 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 3 Anemia occurred in 1 (4%) subject.
Frequency: 1 affected / 38 at risk

Adverse event: Venous thrombosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 3 Venous thrombosis occurred in 1 (4%) subject.
Frequency: 1 affected / 38 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 38 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 38 at risk

Adverse event: Elevated Alkaline Phosphatase Levels
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 38 at risk

Adverse event: Elevated Amylase
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 38 at risk

Adverse event: Elevated Aspartate Aminotransferase Levels
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 38 at risk

Adverse event: Elevated lipase levels
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 38 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 38 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 6 affected / 38 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 38 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 2 affected / 38 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 38 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 38 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 38 at risk