Table 5.
Sub code-/group | Adverse event description | Start date | End date | SAE? | Severity | Plausible relation to study drug | Outcome |
---|---|---|---|---|---|---|---|
032–B coagulans | Acidity | October 24, 2020 | October 24, 2020 | No | Mild | No | Resolved |
032–B coagulans | Vomiting | October 27, 2020 | October 27, 2020 | No | Mild | No | Resolved |
032–B coagulans | Acidity | November 03, 2020 | November 03, 2020 | No | Mild | No | Resolved |
A total of 70 subjects were enrolled and 66 subjects completed the study. One subject in B coagulans group reported mild adverse event which was resolved within a day.
SAE = serious adverse event.