Table 1 Adverse Events Observed in Subjects Completing the Study
Number of adverse events | |||||||
|---|---|---|---|---|---|---|---|
Baseline | Opra Kappa 10 mg × 4 days | ||||||
HV, n =40 | EACD, n =23 | DFFCD, n =7 | |||||
Total | Related | Total | Related | Total | Related | ||
Pruritus | 0 | 5 | 5 | 9 | 9 | 2 | 2 |
Mood change | 0 | 5 | 5 | 4 | 4 | 3 | 3 |
Somnolence/drowsiness | 0 | 6 | 6 | 0 | 0 | 0 | 0 |
Hot flash | 0 | 3 | 3 | 5 | 5 | 1 | 1 |
Headache | 0 | 2 | 2 | 3 | 3 | 1 | 1 |
Nausea | 0 | 0 | 0 | 3 | 3 | 0 | 0 |
Abdominal pain/discomfort | 0 | 3 | 3 | 2 | 2 | 1 | 1 |
Diarrhea | 0 | 1 | 1 | 3 | 3 | 0 | 0 |
Dry mouth | 0 | 0 | 0 | 2 | 2 | 1 | 1 |
Numbness | 0 | 2 | 2 | 0 | 0 | 1 | 1 |
Vivid dreams | 0 | 0 | 0 | 1 | 1 | 0 | 0 |
Appetite suppression | 0 | 0 | 0 | 1 | 1 | 0 | 0 |
