Table 6 Adverse events.
From: Phase II assessment of talabostat and cisplatin in second-line stage IV melanoma
Cycle 1 (n = 74)a | Cycle 2 (n = 61) | Cycle 3 (n = 38) | Cycle 4 (n = 32) | Cycle 5 (n = 19) | Cycle 6 (n = 18) | >Cycle 6 (n = 15) | Overall (N = 74) | |
|---|---|---|---|---|---|---|---|---|
Number of AEs | 448 | 245 | 128 | 79 | 38 | 28 | 105 | 1071 |
No AEs | 7 (9.5)b | 7 (11.5) | 7 (18.4) | 11 (34.4) | 7 (36.8) | 6 (33.3) | 1 (6.7) | 1 (1.4) |
≥ 1AE | 67 (90.5) | 54 (88.5) | 31 (81.6) | 21 (65.6) | 12 (63.2) | 12 (66.7) | 14 (93.3) | 73 (98.6) |
≥ 1Possibly, probably, or definitely talabostat-related AEs | 50 (67.6) | 37 (60.7) | 14 (36.8) | 11 (34.4) | 10 (52.6) | 10 (55.6) | 9 (60.0) | 59 (79.7) |
≥ 1Grade 3 or 4 AEs | 15 (20.3) | 11 (18.0) | 10 (26.3) | 6 (18.8) | 4 (21.1) | 2 (11.1) | 3 (20.0) | 42 (56.8) |
Discontinued talabostat due to ≥ 1 AE | 8 (10.8) | 1 (1.6) | 0 | 1 (3.1) | 1 (5.3) | 0 | 3 (20.0) | 14 (18.9) |
≥ 1SAE | 9 (12.2) | 8 (13.1) | 3 (7.9) | 2 (6.3) | 1 (5.3) | 1 (5.6) | 0 | 23 (31.1) |
Deaths | 10 (13.5) | 12 (19.7) | 6 (15.8) | 5 (15.6) | 1 (5.3) | 1 (5.6) | 4 (26.7) | 39 (52.7) |