TABLE 3.
Phase III open-label study: overall summary of patients with adverse events (safety population)
| PATIENTS, N (%) | PLACEBO/ SARECYCLINE (N=236) |
SARECYCLINE/SARECYCLINE (N=247) |
TOTAL (N=483) |
|---|---|---|---|
| Any TEAE | 94 (39.8) | 94 (38.1) | 188 (38.9) |
| Any severe TEAE | 3 (1.3) | 2 (0.8) | 5 (1.0) |
| SAEs | 2 (0.8) | 2 (0.8) | 4 (0.8) |
| Abdominal pain | 0 | 1 (0.4) | 1 (0.2) |
| Anemia | 1 (0.4) | 0 | 1 (0.2) |
| Dehydration | 0 | 1 (0.4) | 1 (0.2) |
| Headachea | 1 (0.4) | 0 | 1 (0.2) |
| Peptic ulcerb | 1 (0.4) | 0 | 1 (0.2) |
SAE: serious adverse event; TEAE: treatment-emergent adverse event
a
Considered possibly related to study treatment according to the investigator’s assessment
b
Experienced by the same patient with anemia