TABLE 7.
Phase III open-label study: other TEAEs of interest (safety population)
| PATIENTS, N (%) | PLACEBO/ SARECYCLINE (N=236) |
SARECYCLINE/SARECYCLINE (N=247) |
TOTAL (N=483) |
|---|---|---|---|
| Decreased blood TSH | 2 (0.8) | 0 | 2 (0.4) |
| Sunburn | 0 | 1 (0.4) | 1 (0.2) |
| Skin hyperpigmentation | 1 (0.4) | 0 | 1 (0.2) |
| Fungal infection | |||
| Vulvovaginal mycotic infectiona | 0 | 2 (1.6) | 2 (0.8) |
| Genital fungal infection | 0 | 1 (0.4) | 1 (0.2) |
| Genital candidiasis | 1 (0.4) | 0 | 1 (0.2) |
| Body tinea | 0 | 1 (0.4) | 1 (0.2) |
| Tinea infection | 1 (0.4) | 0 | 1 (0.2) |
| Tinea versicolor | 1 (0.4) | 0 | 1 (0.2) |
| Potentially vestibular related | |||
| Nausea | 4 (1.7) | 6 (2.4) | 10 (2.1) |
| Vomiting | 3 (1.3) | 6 (2.4) | 9 (1.9) |
| Dizziness | 1 (0.4) | 1 (0.4) | 2 (0.4) |
| Vertigo | 0 | 0 | 0 |
| Tinnitus | 0 | 0 | 0 |
TSH: thyroid-stimulating hormone; TEAE: treatment-emergent adverse event
a
Percentages were calculated based on the number of female patients