Table 3.

Definitions of investigator-associated clinical and microbiological responses.

Definitions
Clinical response	Assessed by the investigator as resolution or improvement in core clinical signs and symptoms of cUTI present at baseline and no new symptom emerged, or return to pre-infection baseline.
Clinical failure	No apparent response to therapy, persistence of signs and/or symptoms of cUTI infection, or reappearance of signs and/or symptoms that were present at an earlier visit.
Indeterminate clinical response	Observed when the clinical response could not be determined due to the patient being lost to follow-up.
Microbiological eradication	Eradication of baseline Gram-negative pathogen by quantitative microbiological assessment (i.e., urine culture of the causative pathogen growing at ⩾105 CFU/mL at baseline was reduced to <104 CFU/mL).
Microbiological failure	Persistence of baseline Gram-negative pathogen by quantitative microbiological assessment (i.e., urine culture of the causative pathogen growing at ⩾105 CFU/mL at baseline grew at ⩾104 CFU/mL).
Indeterminate microbiological response	No urine culture was taken or a urine culture that could not be interpreted for any reason.

CFU, colony-forming unit; cUTI, complicated urinary tract infection.