Table 3.
Treatment-emergent adverse events by ECOG PS, Child-Pugh status and BCLC stage
| Treatment-emergent adverse events,n(%) | Total (n = 1571) | ECOG PS | Child-Pugh status*,† | BCLC stage*,‡ | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| ≤ 1 (n = 1297) | 2 (n = 143) | A (< 7) (n = 957) | B (7–9) (n = 367) | C (> 9) (n = 35) | A (n = 115) | B (n = 298) | C (n = 851) | D (n = 92) | ||
| AEs (all grades) | 1307 (83) | 1066 (82) | 121 (85) | 780 (82) | 326 (89) | 30 (86) | 82 (71) | 244 (82) | 718 (84) | 76 (83) |
| AEs (grade 3 or 4) | 472 (30) | 391 (30) | 42 (29) | 278 (29) | 115 (31) | 12 (34) | 34 (30) | 101 (34) | 243 (29) | 25 (27) |
| Drug-related AEs (all grades) | 1010 (64) | 850 (66) | 79 (55) | 639 (67) | 230 (63) | 16 (46) | 70 (61) | 206 (69) | 562 (66) | 45 (49) |
| Drug-related AEs (grade 3 or 4) | 366 (23) | 315 (24) | 26 (18) | 228 (24) | 80 (22) | 8 (23) | 29 (25) | 84 (28) | 187 (22) | 19 (21) |
| SAEs§ (all grades) | 587 (37) | 435 (34) | 83 (58) | 278 (29) | 206 (56) | 22 (63) | 27 (24) | 94 (32) | 324 (38) | 51 (55) |
| Drug-related SAEs§ (all grades) | 142 (9) | 123 (9) | 11 (8) | 72 (8) | 54 (15) | 2 (6) | 10 (9) | 35 (12) | 75 (9) | 6 (7) |
| AEs resulting in permanent discontinuation of sorafenib¶ | 434 (28) | 336 (26) | 56 (39) | 225 (24) | 141 (38) | 18 (51) | 28 (24) | 76 (26) | 226 (27) | 40 (44) |
| Deaths** | 343 (22) | 250 (19) | 49 (34) | 154 (16) | 125 (34) | 13 (37) | 14 (12) | 48 (16) | 196 (23) | 34 (37) |
AE, adverse event; BCLC, Barcelona Clinic Liver Cancer; ECOG PS, Eastern Cooperative Oncology Group performance status; SAE, serious adverse event.
At start of therapy.
Child-Pugh status unknown for five patients; 207 patients not evaluable and not tabulated.
Data missing for 13 patients; 202 patients not evaluable and not tabulated.
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.