Table 3.
Safety across prior treatment subgroups (AT population)
| AE, n (%) | RAM | No RAM | PAC (no RAM) | RAM + PAC | No RAM or PAC | IRI | No IRI | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| FTD/ | Placebo | FTD/ | Placebo | FTD/ | Placebo | FTD/ | Placebo | FTD/ | Placebo | FTD/ | Placebo | FTD/ | Placebo | |
| TPI | TPI | TPI | TPI | TPI | TPI | TPI | ||||||||
| (n = 113) | (n = 55) | (n = 222) | (n = 113) | (n = 99) | (n = 36) | (n = 105) | (n = 48) | (n = 123) | (n = 77) | (n = 183) | (n = 97) | (n = 152) | (n = 71) | |
| AE of any cause | 111 (98) | 47 (85) | 215 (97) | 110 (97) | 97 (98) | 36 (100) | 103 (98) | 41 (85) | 118 (96) | 74 (96) | 177 (97) | 90 (93) | 149 (98) | 67 (94) |
| Grade ≥ 3 AE of any cause | 86 (76) | 32 (58) | 181 (82) | 65 (58) | 79 (80) | 22 (61) | 80 (76) | 29 (60) | 102 (83) | 43 (56) | 141 (77) | 52 (54) | 126 (83) | 45 (63) |
| Any serious AE | 40 (35) | 27 (49) | 103 (46) | 43 (38) | 45 (45) | 12 (33) | 38 (36) | 24 (50) | 58 (47) | 31 (40) | 77 (42) | 43 (44) | 66 (43) | 27 (38) |
| AEs leading to treatment discontinuation | 8 (7) | 7 (13) | 35 (16) | 21 (19) | 14 (14) | 7 (19) | 7 (7) | 6 (12) | 21 (17) | 14 (18) | 24 (13) | 11 (11) | 19 (12) | 17 (24) |
| AEs leading to dose modification | 68 (60) | 17 (31) | 127 (57) | 20 (18) | 63 (64) | 7 (19) | 63 (60) | 14 (29) | 64 (52) | 13 (17) | 98 (54) | 26 (27) | 97 (64) | 11 (15) |
AE adverse event, AT as-treated, FTD/TPI trifluridine/tipiracil, IRI irinotecan, PAC paclitaxel, RAM ramucirumab