Table 4.
Specific Treatment-emergent and Drug-related Adverse Events During Intravenous Therapy and the 14-Day Follow-up Period in the Safety Population, as Reported by the Investigator
| IMI/REL (n = 31) | Colistin + IMI (n = 16) | |
|---|---|---|
| Treatment-emergent AEsa (incidence ≥10% in either treatment arm), n (%) | ||
| Pyrexia | 4 (12.9) | 2 (12.5) |
| Increased aspartate aminotransferase | 3 (9.7) | 3 (18.8) |
| Increased alanine aminotransferase | 2 (6.5) | 3 (18.8) |
| Nausea | 2 (6.5) | 3 (18.8) |
| Decreased creatinine renal clearance | 2 (6.5) | 2 (12.5) |
| Increased γ-glutamyltransferase | 1 (3.2) | 2 (12.5) |
| Increased blood alkaline phosphatase | 1 (3.2) | 2 (12.5) |
| Infusion site phlebitis | 1 (3.2) | 2 (12.5) |
| Dizziness | 0 (0.0) | 2 (12.5) |
| Increased blood bilirubin | 0 (0.0) | 2 (12.5) |
| Increased blood creatinine | 0 (0.0) | 4 (25.0) |
| Oral hypoesthesia | 0 (0.0) | 2 (12.5) |
| Drug-related AEsb (any incidence), n (%) | ||
| Decreased creatinine renal clearance | 2 (6.5) | 2 (12.5) |
| Hyperglycemia | 1 (3.2) | 0 |
| Infusion site erythema | 1 (3.2) | 0 |
| Pyrexia | 1 (3.2) | 0 |
| Dizziness | 0 | 2 (12.5) |
| Increased alanine aminotransferase | 0 | 1 (6.3) |
| Increased aspartate aminotransferase | 0 | 1 (6.3) |
| Increased blood creatinine | 0 | 1 (6.3) |
| Oral hypoesthesia | 0 | 1 (6.3) |
| Leukopenia | 0 | 1 (6.3) |
Abbreviations: AE, adverse event; IMI, imipenem/cilastatin; IMI/REL, imipenem/cilastatin plus relebactam.
aTreatment-emergent AEs refers to all reported AEs, regardless of their causality.
bDrug-related AEs refers to those treatment-emergent events that were deemed as related to study treatment by the investigator.