PMC

Patient flow. The detailed reasons for exclusion from each population are summarized in Supplementary Table 1 of the Supplementary appendix. Patients who discontinued the study include those stopped study treatment before receiving the minimum 5 days of treatment for any reason or whose treatment was stopped at any time and for any reason before the complicated intra-abdominal infection was considered resolved or cured, with a nonstudy antibiotic required to complete treatment. Abbreviations: CE, clinically evaluable; MITT, modified intention-to-treat; mMITT, microbiologically MITT.

Difference in clinical cure rates at test-of-cure (TOC) visit by renal function. Dark gray line represents −12.5% noninferiority margin required by the European Medicines Agency for the overall primary populations. Subgroups were not required to meet this noninferiority margin. Confidence intervals (CIs) were calculated using Miettinen and Nurminen method without adjustments. Renal function was based on CrCl reported by the site using the Cockcroft-Gault method [] and based on local laboratory data. Patients with a baseline CrCl <31 mL/min were recorded as having a missing renal status and were not included in the renal status subgroup analyses shown. Clinical cure rates in patients with missing renal status receiving CAZ-AVI plus MTZ or MER, respectively, were 2 of 3 patients (66.6%) and 2 of 2 (100%) in the MITT population; 2 of 2 (100%) and 1 of 1 (100%) in the CE population; and 1 of 3 (33.3%) and 2 of 2 (100%) in the mMITT population. Abbreviations: CAZ-AVI, ceftazidime-avibactam; CE, clinically evaluable; CrCl, creatinine clearance; MER, meropenem; MITT, modified intention-to-treat; mMITT, microbiologically MITT; MTZ, metronidazole.