Table 4.
Summary of Treatment-Emergent Adverse Eventsa (Safety Population)
| TEAE | Secnidazole 2 g (n = 74) | Placebo (n = 73) | ||
|---|---|---|---|---|
| Patientsb, No. (%) | Events, No. | Patientsb, No. (%) | Events, No. | |
| Any TEAE | 11 (14.9) | 13 | 16 (21.9) | 20 |
| Nausea | 2 (2.7) | 2 | 3 (4.1) | 3 |
| Abdominal pain | 1 (1.4) | 1 | 1 (1.4) | 1 |
| Diarrhea | 1 (1.4) | 1 | 2 (2.7) | 2 |
| Vomiting | 1 (1.4) | 1 | 1 (1.4) | 1 |
| Vulvovaginal candidiasis | 2 (2.7) | 2 | 0 | 0 |
| Vulvovaginal mycotic infection | 1 (1.4) | 1 | 0 | 0 |
| Trichomoniasis | 0 | 0 | 2 (2.7) | 2 |
| Productive cough | 1 (1.4) | 1 | 0 | 0 |
| Upper-airway cough syndrome | 1 (1.4) | 1 | 0 | 0 |
| Myalgia | 1 (1.4) | 1 | 0 | 0 |
| Back pain | 0 | 0 | 1 (1.4) | 1 |
| Headache | 1 (1.4) | 1 | 5 (6.8) | 5 |
| Vulvovaginal pruritus | 1 (1.4) | 1 | 0 | 0 |
| Dysmenorrhea | 0 | 0 | 2 (2.7) | 2 |
| Irregular menstruation | 0 | 0 | 1 (1.4) | 1 |
| Thirst | 0 | 0 | 1 (1.4) | 1 |
| Pruritus | 0 | 0 | 1 (1.4) | 1 |
Abbreviation: TEAE, treatment-emergent adverse event.
aIncludes all TEAEs during the primary phase (start date on or before the test-of-cure visit).
bPatients experiencing multiple TEAEs are counted only once within a given cell.