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 |