Table 5. Adverse events in the YH1 and placebo groups.
| Adverse events | YH1 Group (n = 23) |
Placebo Group (n = 23) |
p value |
|---|---|---|---|
| n (%) | n (%) | ||
| Diarrhea | 7 (30.4) | 3 (13.0) | .28 |
| Nausea, bloating, GERD | 5 (21.7) | 8 (34.8) | .51 |
| Dizziness | 0 | 4 (17.4) | - |
| Hypoglycemia | 2 (8.7) | 0 | - |
| Eczema | 1 (4.3) | 1 (4.3) | 1.00 |
| URI | 4 (17.4) | 3 (13.0) | 1.00 |
| Foot cellulitis | 0 | 1 (4.3) | - |
| Hordeolum | 0 | 1 (4.3) | - |
| Constipation | 1 (4.3) | 0 | - |
All adverse effects observed during this trial are listed. Five dropouts, including 2 subjects in the YH1 group and 3 subjects in the placebo group, were also accounted for adverse events and were reported in the safety analysis. The severities of adverse events were all below grade 2 as measured by the CTCAE grading system. Fisher’s exact test was applied for the analysis of categorical data, and there were no significant differences between groups. GERD, gastroesophageal reflux disease; URI, upper respiratory tract infection.