Table 3.
Most Frequent Treatment-emergent Adverse Events (≥2% for Any Group) 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) |
|---|---|---|---|
| Patients with ≥1 TEAE | 510 (47.5) | 284 (41.2) | 188 (48.5) |
| Gastrointestinal disorders | 241 (22.5) | 103 (14.9) | 70 (18.0) |
| Nausea | 160 (14.9) | 60 (8.7) | 21 (5.4) |
| Vomiting | 89 (8.3) | 27 (3.9) | 6 (1.5) |
| Diarrhea | 26 (2.4) | 20 (2.9) | 31 (8.0) |
| General disorders and administration-site conditions | 70 (6.5) | 42 (6.1) | 18 (4.6) |
| Infusion-site extravasation | 28 (2.6) | 19 (2.8) | 0 |
| Infections | 132 (12.3) | 92 (13.4) | 41 (10.6) |
| Wound infection | 30 (2.8) | 22 (3.2) | 0 |
| Cellulitis | 28 (2.6) | 24 (3.5) | 0 |
| Subcutaneous abscess | 23 (2.1) | 27 (3.9) | 0 |
| Investigations | 93 (8.7) | 56 (8.1) | 46 (11.9) |
| ALT increased | 42 (3.9) | 25 (3.6) | 18 (4.6) |
| AST increased | 33 (3.1) | 24 (3.5) | 14 (3.6) |
| GGT increased | 15 (1.4) | 8 (1.2) | 8 (2.1) |
| Nervous system disorders | 49 (4.6) | 32 (4.6) | 12 (3.1) |
| Headache | 31 (2.9) | 21 (3.0) | 5 (1.3) |
| Psychiatric disorders | 23 (2.1) | 13 (1.9) | 17 (4.4) |
| Insomnia | 14 (1.3) | 6 (0.9) | 8 (2.1) |
| Vascular disorders | 36 (3.4) | 8 (1.2) | 16 (4.1) |
| Hypertension | 19 (1.8) | 5 (0.7) | 11 (2.8) |
Data are presented as No. (%). A TEAE was defined as an AE with a start date/time on or after the date/time of the first dose of active study drug. Percentages were based on the number of patients in each treatment group. Patients may have been counted in >1 row.
Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; GGT, γ-glutamyltransferase; TEAE, treatment-emergent adverse event.