Table 2.
Treatment-emergent AEs occurring in >10% of patients in the safety analysis set by CTCAE grade.
| All patients and doses (N = 57) | 160 mg BD melanoma (N = 6) | 240 mg BD melanoma (N = 9) | ||||
|---|---|---|---|---|---|---|
| Any grade | Grade ≥3 | Any grade | Grade ≥3 | Any grade | Grader ≥3 | |
| n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | |
| Patients with any AE | 57 (100%) | 28 (49.1%) | 6 (100%) | 4 (67%) | 5 (56%) | 5 (56%) |
| Anemia | 27 (47%) | 13 (23%) | 5 (83.3%) | 3 (50%) | 2 (22.2%) | 2 (22.2%) |
| Neutropenia and neutrophil count decreased | 24 (42%) | 17 (30%) | 4 (83.3%) | 4 (67%) | 5 (56%) | 5 (56%) |
| Anorexia | 17 (30%) | 0 | 2 (33.3%) | 0 | 2 (22.2%) | 0 |
| Nausea | 17 (30%) | 1 (2%) | 2 (33.3%) | 0 | 3 (33.3%) | 0 |
| Alopecia | 15 (26%) | 0 | 2 (33.3%) | 0 | 0 | 0 |
| Fatigue | 10 (17%) | 0 | 1 (17%) | 0 | 3 (33.3%) | 0 |
| Platelet count decreased and thrombocytopenia | 7 (12%) | 5 (9%) | 1 (17%) | 1 (17%) | 4 (44.4%) | 3 (33.3%) |
| Pruritus | 7 (12%) | 0 | 2 (33.3%) | 0 | 4 (44.4) | 0 |
| Vomiting | 7 (12%) | 1 (2%) | 1 (17%) | 0 | 2 (22.2%) | 0 |
| Rash | 7 (12%) | 0 | 2 (33.3%) | 0 | 1 (11.1%) | 0 |