Safety summary of patients with HMA-naïve CMML in part 2B
| AEs . | TEAEs (N = 21), n (%) . | TRAEs (N = 21), n (%) . |
|---|---|---|
| Any grade | 21 (100) | 19 (90.5) |
| Grade ≥3 | 15 (71.4) | 11 (52.4) |
| Grade ≥3 leading to discontinuation | 1 (4.76) | 1 (4.76)∗ |
| Grade ≥3 leading to dose reduction | 2 (9.52) | 2 (9.52)† |
| SAEs | 7 (33.3) | 6 (28.6) |
| SAE leading to discontinuation | 1 (4.76) | 1 (4.76)∗ |
| SAE leading to dose reduction | 0 | 0 |
| SAE leading to death | 1 (4.76) | 0 |
| TRAEs occurring in ≥10% of patients and any TEAEs of the same type regardless of incidence rate, n (%) | ||
| Nausea | 10 (47.6) | 7 (33.3) |
| Diarrhea | 7 (33.3) | 6 (28.6) |
| Anemia | 7 (33.3) | 5 (23.8) |
| IRR | 5 (23.8) | 5 (23.8) |
| Pruritus | 6 (28.6) | 5 (23.8) |
| Pyrexia | 7 (33.3) | 3 (14.3) |
| Constipation | 11 (52.4) | 3 (14.3) |
| AEs . | TEAEs (N = 21), n (%) . | TRAEs (N = 21), n (%) . |
|---|---|---|
| Any grade | 21 (100) | 19 (90.5) |
| Grade ≥3 | 15 (71.4) | 11 (52.4) |
| Grade ≥3 leading to discontinuation | 1 (4.76) | 1 (4.76)∗ |
| Grade ≥3 leading to dose reduction | 2 (9.52) | 2 (9.52)† |
| SAEs | 7 (33.3) | 6 (28.6) |
| SAE leading to discontinuation | 1 (4.76) | 1 (4.76)∗ |
| SAE leading to dose reduction | 0 | 0 |
| SAE leading to death | 1 (4.76) | 0 |
| TRAEs occurring in ≥10% of patients and any TEAEs of the same type regardless of incidence rate, n (%) | ||
| Nausea | 10 (47.6) | 7 (33.3) |
| Diarrhea | 7 (33.3) | 6 (28.6) |
| Anemia | 7 (33.3) | 5 (23.8) |
| IRR | 5 (23.8) | 5 (23.8) |
| Pruritus | 6 (28.6) | 5 (23.8) |
| Pyrexia | 7 (33.3) | 3 (14.3) |
| Constipation | 11 (52.4) | 3 (14.3) |