Table 3.
Treatment-Emergent Adverse Events for Oritavancin-Treated Patients in the CHROMEa Registry and SOLO Clinical Program
| Adverse Event | CHROME (n = 112), % (n/N) | Pooled SOLO (n = 976), % (n/N) |
|---|---|---|
| Patients with a drug-related adverse event | 4.5 (5/112) | 27.2 (417/1535)b |
| Patients with a drug-related serious adverse event | 0 | 0.33 (5/1535)b |
| Discontinuation due to any adverse event | 0 | 3.7 (36/976)c |
| Incidence of selected adverse event | ||
| Hypersensitivity | 1.8 (2/112) | 7.7 (75/976)d |
| Diarrhea | 1.8 (2/112) | 3.7 (36/976)c |
| Vomiting | 0.9 (1/112) | 4.6 (45/976)c |
| Clostridium difficile–associated diarrhea | 0.9 (1/112) | 0c |
Abbreviation: CHROME, Clinical and Historic Registry and Orbactiv Medical Evaluation.
aIn CHROME, adverse events (AEs) with a reasonable possibility of a causal relationship to oritavancin, as assessed by the Investigator, were reported. In SOLO, AEs for which there was reasonable evidence to suggest a causal relationship between the AE and the study medication and AEs that were considered to be related to the study medication with a high degree of certainty were considered “related.”
bReference 15. Denominator represents total number of treatment-emergent adverse events in 976 patients.
cReference 4.
dData on file.