Table 3.
Summary of Adverse Events During Intravenous Therapy and the 14-Day Follow-up Period in the Safety Population
| Patients With AEs | IMI/REL (n = 31) | Colistin + IMI (n = 16) | Unadjusted Difference (95% Confidence Interval)a |
|---|---|---|---|
| At least 1 AE, n (%) | 22 (71.0) | 13 (81.3) | –10.3 (–33.1, 18.0) |
| Drug-related AEs, n (%) | 5 (16.1) | 5 (31.3) | –15.1 (–42.3, 9.2) |
| Serious AEs, n (%) | 3 (9.7) | 5 (31.3) | –26.1 (–47.8,1.3) |
| Serious drug-related AEs, n (%) | 0 (0.0) | 0 (0.0) | 0.0 (–19.7, 11.2) |
| Deaths, n (%) | 2 (6.5) | 3 (18.8) | –12.3 (–37.8, 6.5) |
| Drug-related deaths, n (%) | 0 (0.0) | 0 (0.0) | 0.0 (–19.7, 11.2) |
| Discontinued drug due to AE, n (%) | 0 (0.0) | 3 (18.8) | –18.8 (–43.3, –6.2) |
| Discontinued drug due to drug-related AE, n (%) | 0 (0.0) | 2 (12.5) | –12.5 (–36.3, –0.3) |
Abbreviations: AE, adverse event; IMI, imipenem/cilastatin; IMI/REL, imipenem/cilastatin plus relebactam.
aBased on the Miettinen and Nurminen method.