Table 2.
Drug exposure in Japanese and non-Japanese patients
| Japanese subpopulation | Non-Japanese subpopulation | |||
|---|---|---|---|---|
| Regorafenib (n = 65) | Placebo (n = 32) | Regorafenib (n = 435) | Placebo (n = 221) | |
| Overall duration of treatment,a weeks | ||||
| Mean ± SD | 10.3 ± 7.9 | 7.3 ± 4.7 | 12.3 ± 10.0 | 7.9 ± 5.3 |
| Median (range) | 7.3 (0.3–28.9) | 7.0 (0.6–22.9) | 7.3 (0.3–47.0) | 7.0 (0.6–38.6) |
| Actual daily dose, mg | ||||
| Mean ± SD | 142.2 ± 20.2 | 158.3 ± 9.4 | 147.9 ± 18.3 | 159.4 ± 3.8 |
| Median (range) | 152.7 (91.1–160.0) | 160.0 (107.0–160.0) | 160.0 (85.7–160.0) | 160.0 (121.6–160.0) |
| Dose intensity (%) | ||||
| Mean ± SD | 69.3 ± 21.2 | 89.1 ± 17.7 | 80.4 ± 19.3 | 90.3 ± 16.1 |
| Median (range) | 71.4 (9.5–100.0) | 98.8 (19.1–100.0) | 83.3 (9.5–114.3) | 100.0 (19.1–100.0) |
| Patients with drug-related adverse events leading to: | ||||
| Dose modification,b n (%) | 55 (84.6) | 6 (18.8) | 223 (51.3) | 17 (7.7) |
| Permanent discontinuation, n (%) | 9 (13.8) | 0 | 32 (7.4) | 3 (1.4) |
aIncludes time off drug and dose interruptions
bIncludes dose interruptions and reductions
Abbreviation: SD, standard deviation