Table 3.
Treatment‐Emergent Adverse Events (TEAEs) in at Least 5% of Patients Treated with Omadacycline in Phase III Study Populations25, 27, 28
| Adverse Events, n (%) | CABP | ABSSSI | ||||
|---|---|---|---|---|---|---|
| OPTIC | OASIS | OASIS‐2 | ||||
| Omadacycline IV/PO (n=382) | Moxifloxacin IV/PO (n=388) | Omadacycline IV/PO (n=323) | Linezolid IV/PO (n=322) | Omadacycline PO (n=368) | Linezolid PO (n=367) | |
| Any TEAE | 157 (41.1) | 188 (48.5) | 156 (48.3) | 147 (45.7) | 197 (53.5) | 137 (37.3) |
| Nausea | 9 (2.4) | 21 (5.4) | 10 (12.4) | 32 (9.9) | 111 (30.2) | 28 (7.6) |
| Infusion site extravasation | 4 (1.0) | 9 (2.3) | 28 (8.7) | 19 (5.9) | – | – |
| Subcutaneous abscess | – | – | 17 (5.3) | 19 (5.9) | – | – |
| Vomiting | 10 (2.6) | 6 (1.5) | 17 (5.3) | 16 (5.0) | 62 (16.8) | 11 (3) |
| Wound Infection | 1 (0.3) | – | 15 (4.6) | 15 (4.7) | 22 (6.0) | 17 (4.6) |
| ALT Increased | 14 (3.7) | 18 (4.6) | 9 (2.8) | 14 (4.3) | 19 (5.2) | 11 (3.0) |
ALT = alanine transaminase; ABSSSI = acute bacterial skin and skin structure infection; CABP = community‐acquired bacterial pneumonia; IV = intravenous; OASIS = Omadacycline in Acute Skin and Skin Infections Study; OPTIC = Omadacycline for Pneumonia Treatment In the Community; PO = oral; TEAE = treatment‐emergent adverse event.