Table 2.
Number of patients (%) | |
---|---|
Clinical adverse events | |
Diarrhea | 3 (3%) |
Muscular pain | 3 (3%) |
Headache | 4 (4%) |
Fatigue | 13 (13.5%) |
Dizziness | 1 (1%) |
Insomnia | 7 (7%) |
Biological Abnormalities* | |
Total serum bilirubin | |
Grade 1 (>ULN − 1.5 × ULN) | 4 (4%) |
Grade 2 (>1.5–3.0 × ULN) | 1 (1%) |
CPK | |
Grade 1 (>ULN − 2.5 × ULN) | 4 (4%) |
Grade 2 (>2.5–5 × ULN) | 1 (1%) |
*Grade classification according to “Common Terminology Criteria for Adverse Events v4.0”34 CPK: creatinine phosphokinase, ULN: upper limit of normal range.