Table 6.
Treatment-Emergent Adverse Events in CHROME for Oritavancin-Treated Single-Dose and Multiple-Dose Patientsa
| Incidence of Selected Adverse Event | All CHROME Patients (n = 440), No. (%) | ||
|---|---|---|---|
| Hypersensitivity | 5 (1.1) | ||
| Diarrhea | 3 (0.7) | ||
| Vomiting | 3 (0.7) | ||
| Clostridioides difficile–associated diarrheab | 1 (0.2) | ||
| Adverse Event | Single-Dose (n = 408), No. (%) | Multiple- Dose (n = 32), No. (%) | All CHROME Patients (n = 440), No. (%) |
| Patients with a drug-related adverse event | 27 (6.6) | 2 (6.3) | 29 (6.6) |
| Patients with a drug-related serious adverse event | 1 (0.2) | 0 (0) | 1 (0.2) |
| Discontinuation due to any adverse event | 5 (1.2) | 1 (3.1) | 6 (1.4) |
aAdverse events with a reasonable possibility of a causal relationship to oritavancin, as assessed by the investigator, were reported.
b Clostridium difficile–associated diarrhea was identified in a single-dose patient.