Study: NCT00215930

Adverse event: Allergic Reaction - Grade 3
Serious: yes
Organ System: General disorders
Notes: Causality: Probably Related
Frequency: 1 affected / 53 at risk

Adverse event: Anemia - Grade 3
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Causality: Possibly Related
Frequency: 1 affected / 53 at risk

Adverse event: Cough - Grade 3
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Causality: Probably Related
Frequency: 1 affected / 53 at risk

Adverse event: Death not associated with CTCAE term - Grade 5
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Causality: Probably Related
Frequency: 1 affected / 53 at risk

Adverse event: Dehydration - Grade 5
Serious: yes
Organ System: General disorders
Notes: Causality: Possibly Related
Frequency: 1 affected / 53 at risk

Adverse event: Dyspnea - Grade 3
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Causality: 1 Probably Related, 1 Unknown
Frequency: 2 affected / 53 at risk

Adverse event: FN-ANC <1.0/Fever >=38.5C - Grade 3
Serious: yes
Organ System: General disorders
Notes: Causality: 1 Possibly Related, 1 Unknown
Frequency: 2 affected / 53 at risk

Adverse event: Fatigue - Grade 3
Serious: yes
Organ System: General disorders
Notes: Causality: 2 Probably Related, 1 Possibly Related, 2 Unknown
Frequency: 4 affected / 53 at risk

Adverse event: Hand/Foot Syndrome - Grade 3
Serious: yes
Organ System: General disorders
Notes: Causality: 1 Probably Related, 1 Definitely Related
Frequency: 2 affected / 53 at risk

Adverse event: Hemoglobin - Grade 3
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Causality: Unknown
Frequency: 2 affected / 53 at risk

Adverse event: Hyperglycemia - Grade 3
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Causality: Unknown
Frequency: 2 affected / 53 at risk

Adverse event: Hypokalemia - Grade 3
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Causality: Unknown
Frequency: 2 affected / 53 at risk

Adverse event: Hyponatremia - Grade 3
Serious: yes
Organ System: General disorders
Notes: Causality: Unknown
Frequency: 3 affected / 53 at risk

Adverse event: Hypoxia - Grade 3
Serious: yes
Organ System: General disorders
Notes: Causality: Probably Related
Frequency: 1 affected / 53 at risk

Adverse event: International Normalization Ratio (INR) - Grade 3
Serious: yes
Organ System: General disorders
Notes: Causality: Unknown
Frequency: 1 affected / 53 at risk

Adverse event: Intracranial Hemorrhage - Grade 5
Serious: yes
Organ System: Vascular disorders
Notes: Causality: Probably Related
Frequency: 1 affected / 53 at risk

Adverse event: Lacrimation - Grade 3
Serious: yes
Organ System: General disorders
Notes: Causality: Probably Related
Frequency: 1 affected / 53 at risk

Adverse event: Leukocytes - Grade 3
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Causality: 1 Probably Related, 4 Unknown
Frequency: 7 affected / 53 at risk

Adverse event: Lymphocytes - Grade 3
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Causality: Unknown
Frequency: 11 affected / 53 at risk

Adverse event: Nail Changes - Grade 3
Serious: yes
Organ System: General disorders
Notes: Causality: Definitely Related
Frequency: 1 affected / 53 at risk

Adverse event: Neuropathy-Motor - Grade 3
Serious: yes
Organ System: General disorders
Notes: Causality: Possibly Related
Frequency: 1 affected / 53 at risk

Adverse event: Neuropathy-Sensory - Grade 3
Serious: yes
Organ System: General disorders
Notes: Causality: Possibly Related
Frequency: 1 affected / 53 at risk

Adverse event: Neutropenia - Grade 3
Serious: yes
Organ System: General disorders
Notes: Causality: Probably Related
Frequency: 2 affected / 53 at risk

Adverse event: Neutropenia - Grade 4
Serious: yes
Organ System: General disorders
Notes: Causality: Probably Related
Frequency: 1 affected / 53 at risk

Adverse event: Neutrophils - Grade 3
Serious: yes
Organ System: General disorders
Notes: Causality: Unknown
Frequency: 5 affected / 53 at risk

Adverse event: Pain/Nausea/Vomiting - Grade 3
Serious: yes
Organ System: General disorders
Notes: Causality: Probably Related
Frequency: 1 affected / 53 at risk

Adverse event: Pedal Edema - Grade 3
Serious: yes
Organ System: General disorders
Notes: Causality: Probably Related
Frequency: 1 affected / 53 at risk

Adverse event: Platelet Count - Grade 3
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Causality: Unknown
Frequency: 1 affected / 53 at risk

Adverse event: Pulmonary Embolism - Grade 4
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Causality: Not Related
Frequency: 1 affected / 53 at risk

Adverse event: RLL DVT - Grade 3
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Causality: Possibly Related
Frequency: 1 affected / 53 at risk

Adverse event: Syncope - Grade 3
Serious: yes
Organ System: Vascular disorders
Notes: Causality: Possibly Related
Frequency: 1 affected / 53 at risk

Adverse event: Thrombocytopenia - Grade 3
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Causality: Probably Related
Frequency: 1 affected / 53 at risk

Adverse event: Hemoglobin - Grade 1
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Causality: Unknown
Frequency: 1 affected / 53 at risk

Adverse event: Hypokalemia - Grade 1
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Causality: Unknown
Frequency: 1 affected / 53 at risk

Adverse event: Leukocytes - Grade 1
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Causality: Unknown
Frequency: 1 affected / 53 at risk

Adverse event: Lymphocytes - Grade 1
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Causality: Unknown
Frequency: 1 affected / 53 at risk

Adverse event: Platelet Count - Grade 1
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Causality: Unknown
Frequency: 1 affected / 53 at risk