TABLE 6.
Summary of treatment-emergent adverse eventsa
| Subject group | Specific adverse event | Relatedness to FEP-ZIDb | Severity |
|---|---|---|---|
| Renal impairment (mild) | Injection site erythema | Certainly | Mild |
| Injection site swelling | Certainly | Moderate | |
| Renal impairment (moderate) | Atrial fibrillation | Unrelated | Moderate |
| Control | Pruritus | Probably/likely | Mild |
| Rash | Probably/likely | Mild |
a
Adverse events following a single intravenous dose of WCK 5222. n = 48.
b
Relationship to FEP-ZID rated as certainly related, probably/likely related, possibly related, unlikely related, not related, or nonassessable.