Table 5.
Most common TEAEs a in ⩾20% of patients treated with sorafenib.
| Preferred term, n (%) | CP-B, n = 47 |
CP-A, n = 427 |
||
|---|---|---|---|---|
| Any grade | Grade ⩾3 | Any grade | Grade ⩾3 | |
| Abdominal pain | 11 (23.4) | 2 (4.3) | 76 (17.8) | 11 (2.6) |
| Alopecia | 2 (4.3) | 0 | 117 (27.4) | 0 |
| Aspartate aminotransferase increased | 12 (25.5) | 9 (19.1) | 68 (15.9) | 29 (6.8) |
| Blood bilirubin increased | 18 (38.3) | 9 (19.1) | 45 (10.5) | 14 (3.3) |
| Constipation | 11 (23.4) | 0 | 41 (9.6) | 0 |
| Decreased appetite | 18 (38.3) | 0 | 109 (25.5) | 6 (1.4) |
| Diarrhea | 18 (38.3) | 2 (4.3) | 202 (47.3) | 18 (4.2) |
| Fatigue | 19 (40.4) | 6 (12.8) | 100 (23.4) | 11 (2.6) |
| Hypertension | 8 (17.0) | 4 (8.5) | 136 (31.9) | 64 (15.0) |
| Palmar-plantar erythrodysesthesia syndrome | 16 (34.0) | 2 (4.3) | 233 (54.6) | 52 (12.2) |
| Weight decreased | 10 (21.3) | 1 (2.1) | 96 (22.5) | 13 (3.0) |
a
AEs were graded using Common Terminology Criteria for Adverse Events version 4.0.
CP, Child-Pugh; TEAEs, treatment-emergent adverse events.