Table 3. Adverse eventsa of interest.
| CC-486 300 mg once daily 14 days/cycle (n=28) | CC-486 300 mg once daily 21 days/cycle (n=27) | |
|---|---|---|
| Adverse events (any grade) | ||
| Gastrointestinal disorders, n (%) | ||
| All | 28 (100) | 27 (100) |
| Diarrhea | 22 (79) | 20 (74) |
| Nausea | 17 (61) | 14 (52) |
| Vomiting | 13 (46) | 16 (59) |
| Infections, n (%) | ||
| All | 18 (64) | 12 (44) |
| Pneumonia | 4 (14) | 1 (4) |
| Cellulitis | 8 (29) | 1 (4) |
| Grade 3–4 adverse events of interest | ||
| All | 19 (68) | 19 (70) |
| Hematologic adverse events, n (%) | ||
| Neutropenia | 2 (7) | 7 (26) |
| Febrile neutropenia | 1 (4) | 3 (11) |
| Thrombocytopenia | 3 (11) | 4 (15) |
| Anemia | 4 (14) | 4 (15) |
| Non-hematologic adverse events, n (%) | ||
| Diarrhea | 2 (7) | 4 (15) |
| Vomiting | 2 (7) | 2 (7) |
| Pneumonia | 4 (14) | 1 (4) |
| Cellulitis | 3 (11) | 1 (4) |
Patient exposures ranged from 1 to 24 CC-486 treatment cycles.
a
Adverse events graded by NCI-CTCAE v3.0.