Study: NCT00121238

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: 2 CTCAE Grade 3 atrial fibrillation occured in 2 separate patients
Frequency: 2 affected / 15 at risk

Adverse event: Arthritis (Gr1)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 2 events of Gr1 arthritis
Frequency: 2 affected / 15 at risk

Adverse event: Increased aspartate aminotransferase (Gr1)
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Gr1 event affecting 1 patient
Frequency: 1 affected / 15 at risk

Adverse event: Constipation (Gr1)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 1 occurence of Gr1 constipation
Frequency: 1 affected / 15 at risk

Adverse event: Diarrhea (Gr1)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 1 occurrence of Gr1 diarrhea
Frequency: 1 affected / 15 at risk

Adverse event: Dry eye syndrome (Gr1)
Serious: no
Organ System: Eye disorders
Notes: 1 occurence of grade 1 dry eye syndrome
Frequency: 1 affected / 15 at risk

Adverse event: Edema (Gr.1)
Serious: no
Organ System: General disorders
Notes: 1 occurence of Gr. 1 edema
Frequency: 1 affected / 15 at risk

Adverse event: Fatigue (Gr.1)
Serious: no
Organ System: General disorders
Notes: 4 occurences of Gr.1 fatigue
Frequency: 4 affected / 15 at risk

Adverse event: Flushing (Gr1)
Serious: no
Organ System: General disorders
Notes: 1 occurence of Gr.1 flushing
Frequency: 1 affected / 15 at risk

Adverse event: Headache (Gr.1)
Serious: no
Organ System: General disorders
Notes: One occurrence of Gr1 headache
Frequency: 1 affected / 15 at risk

Adverse event: Decreased hemoglobin (gr1)
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: 2 occurences of decreased hemoglobin
Frequency: 2 affected / 15 at risk

Adverse event: Hyperglycemia NOS (Gr.1)
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: 1 instance of Gr1 Hyperglycemia
Frequency: 1 affected / 15 at risk

Adverse event: Hyperglycemia (Gr.1)
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: 1 instance of Gr1 Hyperglycemia
Frequency: 1 affected / 15 at risk

Adverse event: Hyponatremia (Gr.1)
Serious: no
Organ System: General disorders
Notes: 1 instance of gr.1 hyponatremia
Frequency: 1 affected / 15 at risk

Adverse event: Memory impairment (Gr.1)
Serious: no
Organ System: Nervous system disorders
Notes: 1 instance of Gr.1 memory impairment
Frequency: 1 affected / 15 at risk

Adverse event: Nausea Gr 1
Serious: no
Organ System: Gastrointestinal disorders
Notes: 1 instance of Gr.1 nausea
Frequency: 1 affected / 15 at risk

Adverse event: Rash (desquamating) (Gr.1)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 1 instance of grade 1 rash
Frequency: 1 affected / 15 at risk

Adverse event: Toothache (Gr.1)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 1 instance of grade 1 toothache
Frequency: 1 affected / 15 at risk

Adverse event: Dyspnea (Gr.2)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: 1 instance of grade 2 dyspnea
Frequency: 1 affected / 15 at risk

Adverse event: Lymphopenia (Gr.2)
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: 1 incident of grade 2 lymphopenia
Frequency: 1 affected / 15 at risk

Adverse event: Osteonecrosis (Gr.2)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 1 instance of grade 2 osteonecrosis
Frequency: 1 affected / 15 at risk