Table 4.
Adverse Events
| Placebo N = 21 | TUDCA N = 26 | p-value | |
|---|---|---|---|
| Distinct adverse events, n (%) | 8 (38%) | 11 (42%) | - |
| Patients with >1 adverse event, n (%) | 7 (33%) | 10 (38%) | 0.77 |
| GI-related adverse event, n (%) | 4 (19%) | 10 (38%) | 0.2 |
| Nausea/Vomiting | - | 2 (8%) | |
| Diarrhea | - | 3 (12%) | |
| Indigestion/Reflux | 1 (5%) | 2 (8%) | |
| Constipation | 1 (5%) | - | |
| Abdominal pain/cramps | 1 (5%) | 2 (8%) | |
| Increased flatulence | 1 (5%) | - | |
| Cholangitis | - | 1 (4%) | |
| Non-GI adverse event, n (%) | 4 (19%) | 1 (3.8%) | 0.16 |
| Urinary tract infection | 2 (10%) | - | |
| Upper respiratory infection | 1 (5%) | - | |
| Deep venous thrombosis | 1 (5%) | - | |
| Facial Rash | - | 1 | |
| Adverse event leading to hospitalization, n (%) | 0 (0%) | 1 (3.8%) | >0.99 |
| Any serious adverse event, n (%) | 0 (0%) | 1 (3.8%) | >0.99 |
a
P-values derived from Fisher’s exact test