Table 2.
Most Common (≥5% of All Patients) Grades 3–4 TEAEs
| AE | CC-486 200 mg QD for 7 Days (n = 3) | CC-486 300 mg QD for 7 Days (n = 4) | CC-486 150 mg QD for 14 Days (n = 4) | CC-486 200 mg QD for 14 Days (n = 19) | Total (N = 30) |
|---|---|---|---|---|---|
| Patients with ≥1 grade 3–4 TEAE | 2 (67) | 3 (75) | 3 (75) | 14 (74) | 22 (73) |
| Hematologic | |||||
| Lymphopenia | 0 | 0 | 3 (75) | 3 (16) | 6 (20) |
| Neutropenia | 0 | 0 | 1 (25) | 4 (21) | 5 (17) |
| Anemia | 0 | 0 | 1 (25) | 3 (16) | 4 (13) |
| Thrombocytopenia | 1 (33) | 0 | 0 | 2 (11) | 3 (10) |
| gastrointestinal | |||||
| Diarrhea | 1 (33) | 0 | 2 (50) | 3 (16) | 6 (20) |
| Vomiting | 1 (33) | 1 (25) | 1 (25) | 2 (11) | 5 (17) |
| Nausea | 1 (33) | 0 | 0 | 3 (16) | 4 (13) |
| GI GVHD* | 0 | 0 | 0 | 3 (16) | 3 (10) |
| Abdominal pain | 0 | 0 | 0 | 2 (11) | 2 (7) |
| Other | |||||
| Device-related infection | 0 | 1 (25) | 1 (25) | 0 | 2 (7) |
| Dehydration | 0 | 0 | 1 (25) | 1 (5) | 2 (7) |
| Pneumonia | 0 | 0 | 1 (25) | 1 (5) | 2 (7) |
Values are n (%). GI indicates gastrointestinal.
Acute or chronic.