Table 6.
Observed treatment-emergent AEs
| AEs | Mild grade
|
Causality assessment | Taken action/outcome | |
|---|---|---|---|---|
| Reference | Test | |||
|
| ||||
| Nausea | 3 (9.7%) | 2 (6.5%) | Possibly related | None/recovered |
| Headache | 1 (3.2%) | 1 (3.2%) | Possibly related | None/recovered |
| Dizziness | 1 (3.2%) | 0 | Possibly related | None/recovered |
| Vasovagal reflex | 1 (3.2%) | 0 | Unclassifiable | Bed rest/recovered |
Notes: The severity grade of all observed AEs was mild. No serious AEs (moderate to severe grade) were observed.
Abbreviation: AEs, adverse events.