Table 4.
Adverse Event Rates of the Safety Population
| AE Category, n (%) | Tedizolid (n = 357) | Linezolid (n = 361) |
|---|---|---|
| Any AE | 327 (91.6) | 325 (90.0) |
| Any TEAE | 326 (91.3) | 325 (90.0) |
| Drug-related TEAE | 29 (8.1) | 43 (11.9) |
| TEAE leading to discontinuation of study drug | 4 (1.1) | 3 (0.8) |
| Any TEAE leading to death | 101 (28.3) | 103 (28.5) |
| Drug-related TEAE leading to death | 0 | 1 (0.3) |
| Serious TEAE | 129 (36.1) | 149 (41.3) |
| Drug-related serious AE | 0 | 4 (1.1) |
| Most common drug-related TEAEsa | ||
| Anemia | 2 (0.6) | 4 (1.1) |
| Thrombocytopenia | 2 (0.6) | 3 (0.8) |
| Diarrhea | 6 (1.7) | 20 (5.5) |
| Nausea | 2 (0.6) | 2 (0.6) |
| Vomiting | 2 (0.6) | 0 |
| Alanine aminotransferase increased | 3 (0.8) | 2 (0.6) |
| Aspartate aminotransferase increased | 2 (0.6) | 2 (0.6) |
| Hepatic enzyme increased | 2 (0.6) | 2 (0.6) |
| Rash | 3 (0.8) | 2 (0.6) |
Four patients were randomized to tedizolid but received linezolid in error. These 4 patients were included in the linezolid safety population (not the tedizolid safety population). One patient was randomized to linezolid but received tedizolid in error. This patient was included in the tedizolid safety population (not the linezolid safety population).
Abbreviations: AE, adverse event; TEAE, treatment-emergent adverse event.
aLimited to drug-related TEAEs recorded in ≥0.5% of patients in the tedizolid treatment group.