Table 3. Adverse Drug Reactionsa.
| Adverse drug reactions | UDCA, 300 mg (n = 172) | UDCA, 600 mg (n = 178) | Placebo (n = 166) | P value | |||
|---|---|---|---|---|---|---|---|
| No. (%) | Exact 95% CI | No. (%) | Exact 95% CI | No. (%) | Exact 95% CI | ||
| Participants with ADRs | 8 (4.7) | 2.03-8.96 | 3 (1.7) | 0.35-4.85 | 3 (1.8) | 0.37-5.19 | .18 |
| Gastrointestinal symptoms | 3 (1.7) | NA | 2 (1.1) | NA | 2 (1.2) | NA | NA |
| Nausea | 2 (1.2) | NA | 1 (0.6) | NA | 1 (0.6) | NA | NA |
| Diarrhea | 0 | NA | 1 (0.6) | NA | 0 | NA | NA |
| Dyspepsia | 0 | NA | 0 | NA | 1 (0.6) | NA | NA |
| Vomiting | 1 (0.6) | NA | 0 | NA | 0 | NA | NA |
| Skin or subcutaneous symptoms | 4 (2.3) | NA | 1 (0.6) | NA | 1 (0.6) | NA | NA |
| Rash | 2 (1.2) | NA | 0 | NA | 1 (0.6) | NA | NA |
| Alopecia | 2 (1.2) | NA | 0 | NA | 0 | NA | NA |
| Pruritus | 1 (0.6) | NA | 0 | NA | 0 | NA | NA |
| Urticaria | 0 | NA | 1 (0.6) | NA | 0 | NA | NA |
| Others | 1 (0.6) | NA | 0 | NA | 0 | NA | NA |
| Chest discomfort | 1 (0.6) | NA | 0 | NA | 0 | NA | NA |
| Participants with serious ADRs | 0 | 0.00-2.12 | 0 | 0.00-2.05 | 0 | 0.00-2.20 | NA |
| Participants with ADRs leading to death | 0 | 0.00-2.12 | 0 | 0.00-2.05 | 0 | 0.00-2.20 | NA |
Abbreviations: ADR, adverse drug reaction; NA, not applicable; UDCA, ursodeoxycholic acid.
a
Patients analyzed who had received at least 1 dose of trial medication after randomization.