Table 4.
Treatment related adverse events (TRAE) in the study population by treatment.
| Variables | Nivolumab group (n = 32) | Regorafenib group (n = 58) | ||
|---|---|---|---|---|
| Any, n (%) | Grade ≥ 3, n (%) | Any, n (%) | Grade ≥ 3, n (%) | |
| Total patients with TRAE* | 12 (37.5) | 2 (6.2) | 40 (68) | 6 (10.2) |
| Hand foot skin reaction, n (%) | 0 | 0 | 14 (23.8) | 1 (1.7) |
| Diarrhea, n (%) | 1 (3.1) | 0 | 7 (11.9) | 0 |
| Fatigue, n (%) | 4 (12.4) | 0 | 6 (10.2) | 2 (3.4) |
| Elevated AST, n (%) | 0 | 0 | 6 (10.2) | 0 |
| Decreased appetite, n(%) | 1(3.1) | 0 | 4 (6.8) | 0 |
| Dermatitis, n (%) | 3 (9.3) | 0 | 4 (6.8) | 0 |
| Elevated T-bil, n (%) | 2 (6.2) | 2 (6.2) | 4 (6.8) | 3 (5.1) |
| Paresthesia, n (%) | 1 (3.1) | 0 | 0 | 0 |
| Hypertension, n (%) | 0 | 0 | 1 (1.7) | 0 |
| Hoarseness, n (%) | 0 | 0 | 1 (1.7) | 0 |
| Pruritus, n (%) | 0 | 0 | 1 (1.7) | 0 |
AST, aspartate aminotransferase; T-bil, total bilirubin; TRAE, treatment related adverse event.
*The comparison of total patients with TRAE between two groups was significant different (p=0.006).