Table 5.
Incidence of Adverse Drug Reactions (Safety Set)
| Fexuprazan | Placebo (n=108) | p-value | ||
|---|---|---|---|---|
| 20 mg once a day (n=109) | 10 mg twice a day (n=108) | |||
| Gastrointestinal disorders | 2 (1.8) [3] | 1 (0.9) [2] | 2 (1.9) [2] | |
| Abdominal distension | 0 | 1 (0.9) [1] | 0 | |
| Abdominal pain | 1 (0.9) [1] | 1 (0.9) [1] | 0 | |
| Bowel habit change | 1 (0.9) [1] | 0 | 0 | |
| Diarrhea | 0 | 0 | 2 (1.9) [2] | |
| Dyspepsia | 1 (0.9) [1] | 0 | 0 | |
| Nervous system disorders | 2 (1.8) [2] | 0 | 0 | |
| Headache | 1 (0.9) [1] | 0 | 0 | |
| Somnolence | 1 (0.9) [1] | 0 | 0 | |
| Renal and urinary disorders | 1 (0.9) [1] | 0 | 0 | |
| Urinary calculus | 1 (0.9) [1] | 0 | 0 | |
| Laboratory abnormalities | 0 | 2 (1.9) [2] | 0 | |
| Liver enzyme elevation | 0 | 1 (0.9) [1] | 0 | |
| Leukopenia | 0 | 1 (0.9) [1] | 0 | |
| Total | 4 (3.7) [6] | 3 (2.8) [4] | 2 (1.9) [2] | 0.912 |
Data are presented as number (%) [case].