Event | Previous clinical trials | ||
---|---|---|---|
HFSR incidence ratio | Â | ||
 All grades | 66.7% (95% CI: 46.0–83.5%) | 76%6, 58.2%7 | |
 Grade 1 | 22.2% (95% CI: 9.6–42.3%) |  | |
 Grade 2 | 37.0% (95% CI: 19.4–57.6%) |  | |
 Grade 3 | 7.4%* (80% CI: 2.0–18.5%) | 21%6, 19%7 | |
Incidence of regorafenib dosage change (discontinuation/interruption/dosage reduction) due to HFSR | Â | ||
 Discontinuation | 0% |  | |
 Interruption | 11% (95% CI: 2.4–29.2%) |  | |
 Dosage reduction | 0% |  | |
Incidence of regorafenib dosage changes due to adverse effects related to aluminum chloride | 0% | Â | |
Time to development of HFSR of any grade, median days | 15.0 days (95% CI: 8.0–47.0) | 7.0 days [17] | |
Time to improvement from HFRS ≥ grade 2 to ≤ grade 1, median days | 8.0 days (95% CI: 4.0–10.0) |  |