Table 3.
Summary of adverse events
| Parameter | Adverse event | ||
|---|---|---|---|
| Increase in no. daily stools | Elevated ALT and AST | Cough and runny nose | |
| No. cases | 5 | 1 | 1 |
| Cohort (no. of cases) | 4 (1), 8 (2), 11 (2) | 4 (1) | 11 (1) |
| Group | Active ingredients | Active ingredients | Placebo |
| Severity | Mild | Mild | Mild |
| Duration, days | 1–2 | 5 | 16 |
| Relationship to study drug | Probably or possibly related | Probably related | Unrelated |
| Outcome | Recovered spontaneously | Recovered spontaneously | Recovered spontaneously |
ALT Alanine aminotransferase, AST Aspartate transaminase