Table 2.
Exposure of Japanese patients with relapsed/refractory peripheral T‐cell lymphoma to pralatrexate in phase I/II study of pralatrexate
| Exposure | Phase I (n = 3) | Phase II (n = 22) | Total (N = 25) |
|---|---|---|---|
| Number of cycles | |||
| Median (range) | 8 (6–11) | 1 (1–9) | 2 (1–11) |
| Cumulative cycles, n (%) | |||
| 1 | 3 (100) | 22 (100) | 25 (100) |
| 2 | 3 (100) | 10 (45) | 13 (52) |
| 3 | 3 (100) | 8 (36) | 11 (44) |
| 4 | 3 (100) | 6 (27) | 9 (36) |
| 5 | 3 (100) | 3 (14) | 6 (24) |
| 6 | 3 (100) | 3 (14) | 6 (24) |
| 7 | 2 (67) | 3 (14) | 5 (20) |
| Number of doses | |||
| Median (range) | 34 (30–49) | 4 (1–48) | 7 (1–49) |
| Treatment duration, days | |||
| Median (range) | 347 (282–547) | 49 (12–445) | 81 (12–547) |
| Discontinued due to AE n (%) | 1 (33) | 5 (23) | 6 (24) |
| Dose reduction due to AE n (%) | 1 (33) | 6 (27) | 7 (28) |
| Dose omission due to AEn (%) | 2 (67) | 20 (91) | 22 (88) |
AE, adverse event.