Table 5.
Overview of Treatment-emergent Adverse Events, by Treatment Group
| Parameter | Omadacycline (n = 691) | Linezolid (n = 689) |
|---|---|---|
| Patients with any TEAE | 353 (51.1) | 284 (41.2) |
| Number of patients (%) with: | ||
| Drug-related TEAE | 197 (28.5) | 111 (16.1) |
| Serious TEAE | 16 (2.3) | 13 (1.9) |
| Drug-related serious TEAE | 0 | 1 (0.1) |
| TEAE leading to deatha | 1 (0.1%) | 3 (0.4) |
| TEAE leading to early discontinuation of study drug | 12 (1.7) | 10 (1.5) |
| TEAE leading to dose interruption of study drug | 2 (0.3) | 0 |
| Serious TEAEs leading to early discontinuation of study drug | 6 (0.9) | 5 (0.7) |
Data are presented as No. (%) and are from the safety population. Percentages were based on the number of patients. If a patient had >1 TEAE with the same preferred term, the patient was counted only once for that preferred term.
Abbreviation: TEAE, treatment-emergent adverse event.
aCauses of death: 1 opiate overdose in the omadacycline group; 1 cardiac arrest, 1 cardiac failure, and 1 illicit drug overdose in the linezolid group.