Table 3.
Incidence of AEs and ADRs
| Placebo (n = 20) | Dotinurad | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 1 mg (n = 20) | 2 mg (n = 19) | 4 mg (n = 21) | Total (n = 60) | |||||||
| AEs | ADRs | AEs | ADRs | AEs | ADRs | AEs | ADRs | AEs | ADRs | |
| Number of events | 16 | 4 | 7 | 3 | 21 | 8 | 18 | 3 | 46 | 14 |
| Number of patients | 7 | 3 | 6 | 3 | 12 | 5 | 11 | 2 | 29 | 10 |
| Incidence (%) | 35.0 | 15.0 | 30.0 | 15.0 | 63.2 | 26.3 | 52.4 | 9.5 | 48.3 | 16.7 |
| χ2 test | P vs. 1 mg | P vs. 2 mg | P vs. 4 mg | 1 mg vs. 2 mg | 1 mg vs. 4 mg | 2 mg vs. 4 mg | P vs. total | Cochran–Armitage test | ||
| P value (AEs) | 0.736 | 0.079 | 0.262 | 0.038* | 0.146 | 0.491 | 0.299 | 0.089 | ||
| P value (ADRs) | 1.000 | 0.382 | 0.592 | 0.382 | 0.592 | 0.163 | 0.861 | 0.859 | ||
Incidence (%) = Number of patients/Number of analyzed patients × 100
Cochran–Armitage test was used in the 1, 2, and 4 mg, and placebo groups
P placebo, Total total of dotinurad
*P < 0.05