Table 3.
Treatment-emergent adverse events by preferred term that were reported in 5 or more patients in either treatment group in the safety population
| Adverse eventa | No. (%) of patients with each adverse event who were given: |
|
|---|---|---|
| Omadacycline (n = 111) | Comparator (n = 108) [no. of subjects given linezolid plus aztreonam] | |
| Nausea | 13 (11.7) | 8 (7.4) [3] |
| Vomiting | 5 (4.5) | 4 (3.7) [1] |
| Diarrhea | 3 (2.7) | 6 (5.6) [5] |
| Constipation | 5 (4.5) | 2 (1.9) [2] |
| Fatigue | 5 (4.5) | 2 (1.9) [1] |
| Alanine aminotransferase increase | 3 (2.7) | 7 (6.5) [6] |
| Aspartate aminotransferase increase | 3 (2.7) | 5 (4.6) [5] |
| Dizziness | 4 (3.6) | 5 (4.6) [2] |
| Headache | 7 (6.3) | 9 (8.3) [5] |
| Rash/rash erythematous | 5 (4.5) | 2 (1.9) [1] |
a
Coded using the Medical Dictionary for Regulatory Affairs, version 12.0.