Table 2.
Overview of Adverse Events in Phase III Acute Bacterial Skin and Skin Structure Infection and Community-acquired Bacterial Pneumonia Studies (AC3 Pool)
| Adverse Event | Omadacycline (n = 1073) | Linezolid (n = 689) | Moxifloxacin (n = 388) |
|---|---|---|---|
| Any TEAE | 510 (47.5) | 284 (41.2) | 188 (48.5) |
| Drug-related TEAE | 236 (22.0) | 111 (16.1) | 69 (17.8) |
| Serious TEAE | 39 (3.6) | 13 (1.9) | 26 (6.7) |
| Drug-related serious TEAE | 2 (0.2) | 1 (0.1) | 2 (0.5) |
| TEAE leading to deatha | 9 (0.8) | 3 (0.4) | 4 (1.0) |
| TEAE leading to premature discontinuation of study drug | 33 (3.1) | 10 (1.5) | 27 (7.0) |
| TEAE leading to dose interruption of study drug | 2 (0.2) | 0 | 0 |
| Serious TEAE leading to premature discontinuation of study drug | 16 (1.5) | 5 (0.7) | 11 (2.8) |
Data are presented as No. (%).
Abbreviation: TEAE, treatment-emergent adverse event.
aCauses of death by preferred term in the omadacycline group were pleural effusion and metastatic lung cancer, overdose, cerebrovascular accident, aortic aneurysm rupture, septic shock, pneumonia and acute respiratory distress syndrome, cardiogenic shock, cardiorespiratory arrest, acute respiratory failure and multiorgan failure, and acute myocardial infarction; in the linezolid group: cardiac failure, cardiac arrest, and unknown; and in the moxifloxacin group: cardiac failure, acute respiratory failure, lung neoplasm, and pancreatic carcinoma.