Table 3.
Treatment-emergent adverse events occurring at any grade in ≥10 patients, and corresponding rates of drug-related treatment-emergent adverse events*
| Adverse events, % | Regorafenib (N=100) |
|||||
| Treatment-emergent | Drug-related treatment-emergent | |||||
| Any grade | Grade 3 | Grade 4 | Any grade | Grade 3 | Grade 4 | |
| Hand–foot skin reaction | 29 | 5 | NA | 27 | 5 | NA |
| Hyperbilirubinaemia | 25 | 13 | 1 | 13 | 5 | 1 |
| Anorexia | 21 | 7 | 0 | 16 | 5 | 0 |
| Fatigue | 20 | 9 | NA | 18 | 8 | NA |
| Hypertension | 20 | 7 | 0 | 16 | 5 | 0 |
| Weight loss | 20 | 1 | NA | 13 | 0 | NA |
| Hypophosphataemia | 19 | 15 | 0 | 15 | 11 | 0 |
| AST increased | 17 | 8 | 0 | 8 | 4 | 0 |
| Diarrhoea | 17 | 3 | 0 | 15 | 2 | 0 |
| Anaemia | 16 | 3 | 0 | 9 | 2 | 0 |
| Hoarseness | 13 | 0 | NA | 9 | 0 | NA |
| Hypothyroidism | 13 | 1 | 0 | 11 | 1 | 0 |
| Alkaline phosphatase increased | 12 | 6 | 0 | 3 | 1 | 0 |
| ALT increased | 12 | 5 | 0 | 7 | 5 | 0 |
Categories and severity by NCI-CTCAE V.4.0.
*Includes events occurring during treatment through the 30-day post-treatment follow-up period.
ALT, alanine aminotransferase; AST, aspartate aminotransferase; NA, not applicable; NCI-CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events.