Table 4.
Treatment-emergent adverse events by initial sorafenib dose and age
| Treatment-emergent adverse events,n(%) | Total (n = 1571) | Initial sorafenib dose | Age | ||
|---|---|---|---|---|---|
| 400 mg (n = 347) | 800 mg (n = 1161) | < 65 years (n = 883) | ≥ 65 years (n = 688) | ||
| AEs (all grades) | 1307 (83) | 318 (92) | 940 (81) | 713 (81) | 594 (86) |
| AEs (grade 3 or 4) | 472 (30) | 123 (35) | 334 (29) | 233 (26) | 239 (35) |
| Drug-related AEs (all grades) | 1010 (64) | 237 (68) | 740 (64) | 530 (60) | 480 (70) |
| Drug-related AEs (grade 3 or 4) | 366 (23) | 84 (24) | 274 (24) | 172 (20) | 194 (28) |
| SAEs* (all grades) | 587 (37) | 152 (44) | 412 (36) | 329 (37) | 258 (38) |
| Drug-related SAEs* (all grades) | 142 (9) | 33 (10) | 101 (9) | 60 (7) | 82 (12) |
| AEs resulting in permanent discontinuation of sorafenib† | 434 (28) | 109 (31) | 309 (27) | 219 (25) | 215 (31) |
| Deaths‡ | 343 (22) | 84 (24) | 248 (21) | 199 (23) | 144 (21) |
AE, adverse event; BCLC, Barcelona Clinic Liver Cancer; SAE, serious adverse event.
*
An SAE is defined as any AE occurring at any dose that results in any of the following outcomes: death; life-threatening; hospitalisation or prolongation of existing hospitalisation; persistent or significant disability/incapacity; congenital anomaly/birth defect; medically important event.
†
Any AE.
‡
Deaths while on treatment and up to 30 days after last study medication dose.