Table 4.
Number of patients with drug-related AEs in >10 % of patients in schedules A and B combined: schedule B (all doses)
| Schedule B (mg) | 18 (n = 3) | 18 (n = 3) | 24 (n = 3) | 32 (n = 4) | 43 (n = 3) | 58 (n = 3) | 78 (n = 3) | 105 (n = 6) | 125 (n = 3) | 150 (n = 3) | 180 (n = 3) | 230 (n = 13) | 270 (n = 13) | 300 (n = 3) | Total (N = 58) | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Grade, n (%) | All | ≥3 | All | ≥3 | All | ≥3 | All | ≥3 | All | ≥3 | All | ≥3 | All | ≥3 | All | ≥3 | All | ≥3 | All | ≥3 | All | ≥3 | All | ≥3 | All | ≥3 | All | ≥3 | All | ≥3 |
| Neutropenia | – | – | – | – | – | – | – | – | – | – | 1 | 1 | – | – | 3 | 3 | 2 | 2 | 1 | 1 | 2 | 2 | 9 | 8 | 5 | 4 | 3 | 3 | 26 (44.8) | 24 (41.4) |
| Fatigue | – | – | 2 | – | – | – | – | – | 2 | – | 2 | – | – | – | 2 | 1 | 1 | – | 2 | – | – | – | 3 | – | 1 | – | 1 | – | 16 (27.6) | 1 (1.7) |
| Leukopenia | – | – | – | – | – | – | – | – | – | – | – | – | – | – | 3 | 3 | 2 | 2 | 1 | 1 | 1 | 1 | 9 | 9 | 4 | 4 | 3 | 3 | 23 (39.7) | 23 (39.7) |
| Nausea | – | – | – | – | – | – | 1 | – | – | – | 1 | – | – | – | 1 | – | 1 | – | 1 | – | 1 | – | 3 | – | 1 | – | 1 | – | 11 (19.0) | – |
| Alopecia | – | – | – | – | 1 | – | – | – | – | – | – | – | – | – | 1 | – | 1 | – | 1 | – | 1 | – | 4 | – | 2 | – | 1 | – | 12 (20.7) | – |
| Diarrhea | 1 | – | – | – | – | – | – | – | – | – | 2 | – | – | – | – | – | – | – | 1 | – | – | – | 3 | – | 2 | – | – | – | 9 (15.5) | – |
| Decreased appetite | – | – | – | – | – | – | 1 | – | – | – | 1 | – | – | – | – | – | – | – | 1 | – | – | – | 2 | – | – | – | 2 | – | 9 (15.5) | – |
AE adverse event