Table 4. . Treatment-emergent adverse events of special interest for tetracyclines in Phase III sarecycline studies.
| Selected TEAE (safety population) | SC1401, n (%) | SC1402, n (%) | ||
|---|---|---|---|---|
| Placebo (n = 483) | Sarecycline (n = 481) | Placebo (n = 513) | Sarecycline (n = 513) | |
| Sunburn | 2 (0.4) | 3 (0.6) | 1(0.2) | 1 (0.2) |
| Urticaria | 1 (0.2) | 0 | 2 (0.4) | 1 (0.2) |
| Vulvovaginal mycotic infection | 0 | 2 (0.7) | 0 | 3 (1.0) |
| Vulvovaginal candidiasis | 0 | 3 (1.1) | 0 | 1 (0.3) |
| Nausea | 12 (2.5) | 22 (4.6) | 5 (1.0) | 10 (1.9) |
| Dizziness | 7 (1.4) | 3 (0.6) | 4 (0.8) | 2 (0.4) |
| Vomiting | 7 (1.4) | 10 (2.1) | 2 (0.4) | 3 (0.6) |
| Diarrhea | 8 (1.7) | 5 (1.0) | 6 (1.2) | 6 (1.2) |
| Esophagitis | 0 | 0 | 0 | 0 |
| Tinnitus | 0 | 0 | 0 | 0 |
| Vertigo | 0 | 0 | 0 | 0 |
| Pseudotumor cerebri | 0 | 0 | 0 | 0 |