TABLE 5.
Phase III open-label study: common TEAEs (≥2% of patients in either group; safety population)
| PATIENTS, N (%) | PLACEBO/ SARECYCLINE (N=236) |
SARECYCLINE/SARECYCLINE (N=247) |
TOTAL (N=483) |
|---|---|---|---|
| Nasopharyngitisa | 13 (5.5) | 5 (2.0) | 18 (3.7) |
| Upper-respiratory-tract infection | 7 (3.0) | 9 (3.6) | 16 (3.3) |
| Headache | 9 (3.8) | 5 (2.0)b | 14 (2.9)b |
| Nausea | 4 (1.7)b | 6 (2.4) | 10 (2.1)b |
| Vomiting | 3 (1.3)b | 6 (2.4) | 9 (1.9)b |
| Urinary tract infection | 2 (0.8) | 5 (2.0) | 7 (1.4) |
a
One patient in each treatment group had an AE that occurred more than 30 days after the dose of sarecycline
b
One of these TEAEs was an AE that occurred more than 30 days after the last dose of sarecycline but before study completion
AE: adverse event; TEAE: treatment-emergent adverse event