Table 2.

Drug-related all-grade adverse events in 15% or more of patients and grade III or higher adverse events in 5% or more of patients, by dose and schedule

Once daily 7-d 5 mg (n = 3)Once daily 7-d 80 mg (n = 3)Once daily 7-d 150 mg (n = 3)Twice daily 7-d 50 mg (n = 14)Twice daily 7-d 60 mg (n = 6)Twice daily 7-d 75 mg (n = 3)Twice daily 7-d 100 mg (n = 6)Once daily 14-d 50 mg (n = 7)Once daily 21-d 50 mg (n = 7)Once daily 21-d 70 mg (n = 7)Total (N = 59), n (%)
All-grade adverse events (≥15%), n123753657746 (78)
 Alopecia023042413524 (41)
 Neutropenia003342523224 (41)
 Somnolence022321301519 (32)
 Leukopenia002321611218 (31)
 Stomatitis012322403118 (31)
 Anemia011122313014 (24)
 Asthenia001122213214 (24)
 Nausea002021311313 (22)
 Diarrhea001112211211 (19)
 Thrombocytopenia002211410011 (19)
 Vomiting001021301311 (19)
Grade ≥III adverse events (≥5%), n002342633225 (42)
 Neutropenia002242512220 (34)
 Leukopenia001121610113 (22)
 Thrombocytopenia00111031007 (12)
 Anemia00101120106 (10)
 Lymphopenia00110001104 (7)
 Stomatitis00010030004 (7)