Table 5.
Treatment-emergent drug-related adverse events (any grade) in ≥ 5% of the total study population stratified by initial sorafenib dose, Child-Pugh status and BCLC stage at start of therapy
| n(%) | Total Any grade (n = 1571) | Initial sorafenib dose | Child-Pugh status | BCLC stage | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 400 mg (n = 347) | 800 mg (n = 1161) | 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) | ||
| Any adverse event | 1010 (64) | 237 (68) | 740 (64) | 639 (67) | 230 (63) | 16 (46) | 70 (61) | 206 (69) | 562 (66) | 45 (49) |
| Diarrhoea | 387 (25) | 90 (26) | 289 (25) | 248 (26) | 86 (23) | 3 (9) | 26 (23) | 95 (32) | 217 (26) | 13 (14) |
| Hand-foot skin reaction | 380 (24) | 79 (23) | 293 (25) | 278 (29) | 54 (15) | 1 (3) | 22 (19) | 91 (31) | 213 (25) | 14 (15) |
| Fatigue | 222 (14) | 60 (17) | 157 (14) | 139 (15) | 41 (11) | 6 (17) | 18 (16) | 41 (14) | 122 (14) | 10 (11) |
| Rash/desquamation | 190 (12) | 47 (14) | 140 (12) | 123 (13) | 36 (10) | 2 (6) | 14 (12) | 41 (14) | 96 (11) | 9 (10) |
| Anorexia | 141 (9) | 31 (9) | 108 (9) | 93 (10) | 30 (8) | 1 (3) | 12 (10) | 24 (8) | 84 (10) | 6 (7) |
| Hypertension | 104 (7) | 25 (7) | 78 (7) | 85 (9) | 11 (3) | 0 | 5 (4) | 23 (8) | 66 (8) | 2 (2) |
| Alopecia | 102 (7) | 19 (6) | 82 (7) | 79 (8) | 11 (3) | 1 (3) | 8 (7) | 21 (7) | 63 (7) | 3 (3) |
| Nausea | 93 (6) | 26 (8) | 65 (6) | 51 (5) | 18 (5) | 2 (6) | 10 (9) | 6 (2) | 44 (5) | 9 (10) |
| Weight loss | 74 (5) | 14 (4) | 60 (5) | 45 (5) | 15 (4) | 1 (3) | 11 (10) | 18 (6) | 34 (4) | 3 (3) |
BCLC, Barcelona Clinic Liver Cancer.