Figure 1. Patient Disposition and Analysis Populations.

Analysis populations referenced in this study are described in the Methods section. Other study populations are defined in eTable 1 in Supplement 3.

^aThe inclusion and exclusion criteria are listed in the eBox in Supplement 3.

^bIntravenous drug administration was not feasible in this patient and therefore the patient was not able to comply with the protocol.

^cA patient could discontinue treatment but remain in the study, discontinue treatment but discontinue study at a later date, or discontinue treatment and discontinue study at the same time.

^dThree patients refused continuation of study treatment; 1 patient did not have clinical improvement; 1 patient was deemed resistant to cefepime; 1 patient had an estimated glomerular filtration rate drop below 30 mL/min/1.73 m² on day 2; 1 patient did not receive last dose on day 7 by error; in 1 patient treatment could not be continued due to lack of investigational product; and 1 patient discharged themself early.

^eNine patients did not return to site for assessment but were contacted and 1 with whom contact was lost.

^fTwo patients refused continuation of study treatment and 1 patient had a negative confirmation result of urine culture.

^gFour patients did not return to site for assessment but were contacted and 1 patient had a negative confirmation result of urine culture.

^hIncludes 10 patients who had a baseline culture that was considered contaminated and 16 patients with a baseline gram-positive pathogen only.