TABLE 3.
Most commonly reported treatment-emergent adverse events (≥1% in either treatment group) in the safety population
| TEAEa | No. (%) of patients with the indicated TEAE |
|
|---|---|---|
| 200 mg tedizolid once daily | 600 mg linezolid twice daily | |
| Total no. of patients | 662 | 662 |
| Gastrointestinal disorders | 106 (16.0)b | 152 (23.0) |
| Nausea | 54 (8.2)b | 81 (12.2) |
| Diarrhea | 26 (3.9) | 35 (5.3) |
| Vomiting | 19 (2.9)b | 37 (5.6) |
| Constipation | 9 (1.4) | 6 (0.9) |
| Dyspepsia | 4 (0.6) | 8 (1.2) |
| Infections and infestations | 91 (13.7) | 78 (11.8) |
| Abscess | 35 (5.3) | 26 (3.9) |
| Cellulitis | 17 (2.6) | 14 (2.1) |
| Vulvovaginal mycotic infection | 2 (0.3) | 9 (1.4) |
| Nervous system disorders | 65 (9.8) | 67 (10.1) |
| Headache | 41 (6.2) | 39 (5.9) |
| Dizziness | 12 (1.8) | 14 (2.1) |
| Skin and subcutaneous tissue disorders | 47 (7.1) | 40 (6.0) |
| Pruritus generalized | 11 (1.7) | 7 (1.1) |
| Pruritus | 3 (0.5) | 9 (1.4) |
| General disorders and administration site conditions | 36 (5.4) | 39 (5.9) |
| Fatigue | 9 (1.4) | 12 (1.8) |
| Psychiatric disorders | 17 (2.6) | 8 (1.2) |
| Insomnia | 10 (1.5) | 5 (0.8) |
a
TEAE, treatment-emergent adverse event.
b
P < 0.05.