Study: NCT00365599

Adverse event: Decreased appetite
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 2, probably related
Frequency: 1 affected / 43 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 3, possibly related
Frequency: 1 affected / 43 at risk

Adverse event: Hemorrhage/Bleeding
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 2, possibly related
Frequency: 1 affected / 43 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 3, related
Frequency: 1 affected / 43 at risk

Adverse event: Platelets
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 4, related
Frequency: 1 affected / 43 at risk

Adverse event: Sodium, serum-low (hyponatremia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Grade 3, possibly related
Frequency: 1 affected / 43 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Notes: Grade 4, possibly related
Frequency: 2 affected / 43 at risk

Adverse event: Alopecia - Grade 2
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 43 at risk

Adverse event: Anorexia/weight loss - Grade 2
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 43 at risk

Adverse event: Anorexia/weight loss - Grade 3
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 43 at risk

Adverse event: Deep vein thrombosis/pulmonary embolish (DVT/PE) - Grade 4
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 43 at risk

Adverse event: Diarrhea - Grade 2
Serious: no
Organ System: Gastrointestinal disorders
Notes: (There was also one Grade 3 event, below the Frequency Threshold for reporting)
Frequency: 7 affected / 43 at risk

Adverse event: Fatigue - Grade 2
Serious: no
Organ System: General disorders
Frequency: 8 affected / 43 at risk

Adverse event: Fatigue - Grade 3
Serious: no
Organ System: General disorders
Frequency: 7 affected / 43 at risk

Adverse event: Hepatic dysfunction (alanine aminotransferase/aspartate aminotransferase [ALT/AST]) - Grade 2
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: (There was also one Grade 3 event, below the Frequency Threshold for reporting)
Frequency: 3 affected / 43 at risk

Adverse event: Hyperglycemia - Grade 2
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: (There were also 2 Grade 3 events, below the Frequency Threshold for reporting)
Frequency: 5 affected / 43 at risk

Adverse event: Leukopenia - Grade 2
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: (There were also 2 Grade 3 events, below the Frequency Threshold for reporting)
Frequency: 4 affected / 43 at risk

Adverse event: Lymphopenia - Grade 2
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 43 at risk

Adverse event: Lymphopenia - Grade 3
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 43 at risk

Adverse event: Nausea - Grade 2
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 43 at risk

Adverse event: Neutropenia - Grade 2
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 43 at risk

Adverse event: Neutropenia - Grade 3
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 43 at risk

Adverse event: Thrombocytopenia - Grade 2
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 43 at risk

Adverse event: Thrombocytopenia - Grade 3
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: (There was also one Grade 4 event, below the Frequency Threshold for reporting)
Frequency: 3 affected / 43 at risk