Table 9 Adverse events by severity and causality.
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) | |
|---|---|---|---|---|---|---|---|---|
Severity | ||||||||
Grade 1 | 19 (25.7)b | 13 (21.3) | 8 (21.1) | 8 (25.0) | 6 (31.6) | 8 (44.4) | 8 (53.3) | 6 (8.1) |
Grade 2 | 33 (44.6) | 30 (49.2) | 13 (34.2) | 7 (21.9) | 2 (10.5) | 2 (11.1) | 3 (20.0) | 25 (33.8) |
Grade 3 | 10 (13.5) | 9 (14.8) | 8 (21.1) | 4 (12.5) | 2 (10.5) | 2 (11.1) | 2 (13.3) | 28 (37.8) |
Grade 4 | 3 (4.1) | 0 | 1 (2.6) | 1 (3.1) | 2 (10.5) | 0 | 1 (6.7) | 8 (10.8) |
Grade 5 | 2 (2.7) | 2 (3.3) | 1 (2.6) | 1 (3.1) | 0 | 0 | 0 | 6 (8.1) |
Relationship to talabostat c | ||||||||
Not related | 6 (8.1) | 11 (18.0) | 7 (18.4) | 5 (15.6) | 0 | 1 (5.6) | 3 (20.0) | 6 (8.1) |
Unlikely | 11 (14.9) | 6 (9.8) | 10 (26.3) | 5 (15.6) | 2 (10.5) | 1 (5.6) | 2 (13.3) | 8 (10.8) |
Possible | 33 (44.6) | 31 (50.8) | 9 (23.7) | 10 (31.3) | 8 (42.1) | 7 (38.9) | 4 (26.7) | 38 (51.4) |
Probable | 10 (13.5) | 2 (3.3) | 4 (10.5) | 0 | 1 (5.3) | 2 (11.1) | 3 (20.0) | 11 (14.9) |
Definite | 7 (9.5) | 4 (6.6) | 1 (2.6) | 1 (3.1) | 1 (5.3) | 1 (5.6) | 2 (13.3) | 10 (13.5) |
Relationship to cisplatin c | ||||||||
Not related | 3 (4.1) | 5 (8.2) | 5 (13.2) | 3 (9.4) | 1 (5.3) | 2 (11.1) | 4 (26.7) | 3 (4.1) |
Unlikely | 4 (5.4) | 5 (8.2) | 5 (13.2) | 2 (6.3) | 3 (15.8) | 2 (11.1) | 2 (13.3) | 2 (2.7) |
Possible | 14 (18.9) | 11 (18.0) | 4 (10.5) | 4 (12.5) | 1 (5.3) | 2 (11.1) | 1 (6.7) | 11 (14.9) |
Probable | 28 (37.8) | 18 (29.5) | 9 (23.7) | 6 (18.8) | 5 (26.3) | 5 (27.8) | 5 (33.3) | 30 (40.5) |
Definite | 18 (24.3) | 15 (24.6) | 8 (21.1) | 6 (18.8) | 2 (10.5) | 1 (5.6) | 2 (13.3) | 27 (36.5) |