Table 3.
Summary of Adverse Events During Intravenous Therapy and the 14-Day Follow-up Period in the Safety Population
| Patients With Adverse Events | IMI/REL (n = 266a) | PIP/TAZ (n = 269a) | Unadjusted Difference, % (95% CI)b |
|---|---|---|---|
| At least 1 AE | 226 (85.0) | 233 (86.6) | −1.7 (−7.7 to 4.3) |
| Drug-relatedc AEs | 31 (11.7) | 26 (9.7) | 2.0 (−3.3 to 7.4) |
| Serious AEs | 71 (26.7) | 86 (32.0) | −5.3 (−13.0 to 2.5) |
| Serious drug-relatedc AEs | 3 (1.1) | 2 (0.7) | 0.4 (−1.7 to 2.6) |
| Deaths | 40 (15.0) | 57 (21.2) | −6.2 (−12.7 to .4) |
| Drug-relatedc deaths | 0 (0.0) | 0 (0.0) | 0.0 (−1.4 to 1.4) |
| Discontinued drug due to AE | 15 (5.6) | 22 (8.2) | −2.5 (−7.1 to 1.8) |
| Discontinued drug due to drug-relatedc AE | 6 (2.3)d | 4 (1.5)e | 0.8 (−1.8 to 3.5) |
Data are presented as the number (%) of patients who had at least 1 of the indicated type of AE, unless otherwise indicated.
Abbreviations: AE, adverse event; CI, confidence interval; IMI/REL, imipenem/cilastatin with relebactam; PIP/TAZ, piperacillin/tazobactam.
aOverall values indicate the total number of patients in the safety population of the particular treatment arm.
bBased on the Miettinen and Nurminen method [28].
cAE causality in relation to the study therapy was determined by the investigator.
dSpecific drug-related AEs that led to study therapy discontinuation were as follows: liver function abnormalities (n = 2), rash (n = 2), and thrombocytopenia/decreased platelet count (n = 2).
eSpecific drug-related AEs that led to study therapy discontinuation were as follows: liver function abnormalities (n = 1), hallucinations (n = 1), generalized tonic-clonic seizure (n = 1), and pyrexia (n = 1).