TABLE 4.
Overall safety: treatment-emergent adverse events (safety population)
| TEAE typea | Value for the group (no. of patients [%]) |
|
|---|---|---|
| Tedizolid phosphate (N = 292)b | Linezolid (N = 297)c | |
| Any event | 145 (49.7) | 136 (45.8) |
| Mild | 95 (32.5) | 89 (30.0) |
| Moderate | 37 (12.7) | 40 (13.5) |
| Severe | 12 (4.1) | 7 (2.4) |
| Missing | 1 (0.3) | 0 (0) |
| Drug-related event | 61 (20.9) | 47 (15.8) |
| Serious event | 11 (3.8) | 8 (2.7) |
| Drug-related serious event | 0 (0) | 0 (0) |
| Event leading to discontinuation of study drug | 6 (2.1) | 6 (2.0) |
| Serious event leading to discontinuation of study drug | 0 (0) | 3 (1.0) |
| Any event leading to death | 0 (0) | 0 (0) |
a
TEAE, treatment-emergent adverse event.
b
Dosed 200 mg once daily for 6 days.
c
Dosed at 600 mg twice daily for 10 days.