Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (≥10^5 CFU/mL) is eradicated to <10^3 CFU/mL. Clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI.

The microITT analysis population consists of all patients in the ITT analysis population who had a positive study entry urine culture defined as ≥10^5 CFU/mL of a gram-negative pathogen(s) against which both cefepime/VNRX-5133 and meropenem have antibacterial activity AND those patients who had no more than 2 microorganisms identified in the study entry culture regardless of colony count.

Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (≥10^5 CFU/mL) is eradicated to <10^3 CFU/mL.

The microITT analysis population consists of all patients in the ITT analysis population who had a positive study entry urine culture defined as ≥10^5 CFU/mL of a gram-negative pathogen(s) against which both cefepime/VNRX-5133 and meropenem have antibacterial activity AND those patients who had no more than 2 microorganisms identified in the study entry culture regardless of colony count.

Symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI.

The microITT analysis population consists of all patients in the ITT analysis population who had a positive study entry urine culture defined as ≥10^5 CFU/mL of a gram-negative pathogen(s) against which both cefepime/VNRX-5133 and meropenem have antibacterial activity AND those patients who had no more than 2 microorganisms identified in the study entry culture regardless of colony count.

Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (≥10^5 CFU/mL) is eradicated to <10^3 CFU/mL. Symptomatic clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI.

The extended microITT analysis population consists of all patients in the ITT analysis population who had a positive study entry urine culture defined as ≥10^5 CFU/mL of a gram-negative pathogen(s) against which at least 1 study drug (cefepime/VNRX-5133 and/or meropenem) have antibacterial activity AND those patients who had no more than 2 microorganisms identified in the study entry culture regardless of colony count.

Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (≥10^5 CFU/mL) is eradicated to <10^3 CFU/mL. Clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI.

The microITT analysis population consists of all patients in the ITT analysis population who had a positive study entry urine culture defined as ≥10^5 CFU/mL of a gram-negative pathogen(s) against which both cefepime/VNRX-5133 and meropenem have antibacterial activity AND those patients who had no more than 2 microorganisms identified in the study entry culture regardless of colony count.

Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (≥10^5 CFU/mL) is eradicated to <10^3 CFU/mL.

The microITT analysis population consists of all patients in the ITT analysis population who had a positive study entry urine culture defined as ≥10^5 CFU/mL of a gram-negative pathogen(s) against which both cefepime/VNRX-5133 and meropenem have antibacterial activity AND those patients who had no more than 2 microorganisms identified in the study entry culture regardless of colony count.

Clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI.

The microITT analysis population consists of all patients in the ITT analysis population who had a positive study entry urine culture defined as ≥10^5 CFU/mL of a gram-negative pathogen(s) against which both cefepime/VNRX-5133 and meropenem have antibacterial activity AND those patients who had no more than 2 microorganisms identified in the study entry culture regardless of colony count.

Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (≥10^5 CFU/mL) is eradicated to <10^3 CFU/mL. Clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI.

The microITT analysis population consists of all patients in the ITT analysis population who had a positive study entry urine culture defined as ≥10^5 CFU/mL of a gram-negative pathogen(s) against which both cefepime/VNRX-5133 and meropenem have antibacterial activity AND those patients who had no more than 2 microorganisms identified in the study entry culture regardless of colony count.

Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (≥10^5 CFU/mL) is eradicated to <10^3 CFU/mL.

The microITT analysis population consists of all patients in the ITT analysis population who had a positive study entry urine culture defined as ≥10^5 CFU/mL of a gram-negative pathogen(s) against which both cefepime/VNRX-5133 and meropenem have antibacterial activity AND those patients who had no more than 2 microorganisms identified in the study entry culture regardless of colony count.

Clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI.

The microITT analysis population consists of all patients in the ITT analysis population who had a positive study entry urine culture defined as ≥10^5 CFU/mL of a gram-negative pathogen(s) against which both cefepime/VNRX-5133 and meropenem have antibacterial activity AND those patients who had no more than 2 microorganisms identified in the study entry culture regardless of colony count.

The proportion of patients with clinical success based on investigator opinion at TOC.

The microITT analysis population consists of all patients in the ITT analysis population who had a positive study entry urine culture defined as ≥10^5 CFU/mL of a gram-negative pathogen(s) against which both cefepime/VNRX-5133 and meropenem have antibacterial activity AND those patients who had no more than 2 microorganisms identified in the study entry culture regardless of colony count.

Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (≥10^5 CFU/mL) is eradicated to <10^3 CFU/mL. Clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI.

The microITT analysis population consists of all patients in the ITT analysis population who had a positive study entry urine culture defined as ≥10^5 CFU/mL of a gram-negative pathogen(s) against which both cefepime/VNRX-5133 and meropenem have antibacterial activity AND those patients who had no more than 2 microorganisms identified in the study entry culture regardless of colony count.

Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (≥10^5 CFU/mL) is eradicated to <10^3 CFU/mL.

The microITT analysis population consists of all patients in the ITT analysis population who had a positive study entry urine culture defined as ≥10^5 CFU/mL of a gram-negative pathogen(s) against which both cefepime/VNRX-5133 and meropenem have antibacterial activity AND those patients who had no more than 2 microorganisms identified in the study entry culture regardless of colony count.

Clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI.

The microITT analysis population consists of all patients in the ITT analysis population who had a positive study entry urine culture defined as ≥10^5 CFU/mL of a gram-negative pathogen(s) against which both cefepime/VNRX-5133 and meropenem have antibacterial activity AND those patients who had no more than 2 microorganisms identified in the study entry culture regardless of colony count.

Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (≥10^5 CFU/mL) is eradicated to <10^3 CFU/mL. Clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI.

The microITT analysis population consists of all patients in the ITT analysis population who had a positive study entry urine culture defined as ≥10^5 CFU/mL of a gram-negative pathogen(s) against which both cefepime/VNRX-5133 and meropenem have antibacterial activity AND those patients who had no more than 2 microorganisms identified in the study entry culture regardless of colony count.

Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (≥10^5 CFU/mL) is eradicated to <10^3 CFU/mL.

The microITT analysis population consists of all patients in the ITT analysis population who had a positive study entry urine culture defined as ≥10^5 CFU/mL of a gram-negative pathogen(s) against which both cefepime/VNRX-5133 and meropenem have antibacterial activity AND those patients who had no more than 2 microorganisms identified in the study entry culture regardless of colony count.

Clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI.

The microITT analysis population consists of all patients in the ITT analysis population who had a positive study entry urine culture defined as ≥10^5 CFU/mL of a gram-negative pathogen(s) against which both cefepime/VNRX-5133 and meropenem have antibacterial activity AND those patients who had no more than 2 microorganisms identified in the study entry culture regardless of colony count.

Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (≥10^5 CFU/mL) is eradicated to <10^3 CFU/mL. Clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI.

The microITT analysis population consists of all patients in the ITT analysis population who had a positive study entry urine culture defined as ≥10^5 CFU/mL of a gram-negative pathogen(s) against which both cefepime/VNRX-5133 and meropenem have antibacterial activity AND those patients who had no more than 2 microorganisms identified in the study entry culture regardless of colony count.

Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (≥10^5 CFU/mL) is eradicated to <10^3 CFU/mL.

The microITT analysis population consists of all patients in the ITT analysis population who had a positive study entry urine culture defined as ≥10^5 CFU/mL of a gram-negative pathogen(s) against which both cefepime/VNRX-5133 and meropenem have antibacterial activity AND those patients who had no more than 2 microorganisms identified in the study entry culture regardless of colony count.

Clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI.

The microITT analysis population consists of all patients in the ITT analysis population who had a positive study entry urine culture defined as ≥10^5 CFU/mL of a gram-negative pathogen(s) against which both cefepime/VNRX-5133 and meropenem have antibacterial activity AND those patients who had no more than 2 microorganisms identified in the study entry culture regardless of colony count.

Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (≥10^5 CFU/mL) is eradicated to <10^3 CFU/mL. Clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI.

All patients who meet the criteria for the microITT population AND had a diagnosis of cUTI; received treatment for ≥48 hours; were evaluated at EOT with a response that was not indeterminate; did not violate prior antibacterials exclusion or received concomitant antibiotic therapy with activity against baseline pathogens except for patients failing study drug; or had other confounding factors that interfered with the assessment of outcome including unblinding.

Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (≥10^5 CFU/mL) is eradicated to <10^3 CFU/mL.

All patients who meet the criteria for the microITT population AND had a diagnosis of cUTI; received treatment for ≥48 hours; were evaluated at EOT with a response that was not indeterminate; did not violate prior antibacterials exclusion or received concomitant antibiotic therapy with activity against baseline pathogens except for patients failing study drug; or had other confounding factors that interfered with the assessment of outcome including unblinding.

Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (≥10^5 CFU/mL) is eradicated to <10^3 CFU/mL. Symptomatic clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI.

All patients who meet the criteria for the microITT population AND had a diagnosis of cUTI; received treatment for ≥48 hours; were evaluated at TOC with a response that was not indeterminate; did not violate prior antibacterials exclusion or received concomitant antibiotic therapy with activity against baseline pathogens except for patients failing study drug; or had other confounding factors that interfered with the assessment of outcome including unblinding.

Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (≥10^5 CFU/mL) is eradicated to <10^3 CFU/mL.

All patients who meet the criteria for the microITT population AND had a diagnosis of cUTI; received treatment for ≥48 hours; were evaluated at TOC with a response that was not indeterminate; did not violate prior antibacterials exclusion or received concomitant antibiotic therapy with activity against baseline pathogens except for patients failing study drug; or had other confounding factors that interfered with the assessment of outcome including unblinding.

Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (≥10^5 CFU/mL) is eradicated to <10^3 CFU/mL. Symptomatic clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI.

All patients who meet the criteria for the microITT population AND had a diagnosis of cUTI; received treatment for ≥48 hours; were evaluated at LFU with a response that was not indeterminate; did not violate prior antibacterials exclusion or received concomitant antibiotic therapy with activity against baseline pathogens except for patients failing study drug; or had other confounding factors that interfered with the assessment of outcome including unblinding.

Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (≥10^5 CFU/mL) is eradicated to <10^3 CFU/mL.

All patients who meet the criteria for the microITT population AND had a diagnosis of cUTI; received treatment for ≥48 hours; were evaluated at LFU with a response that was not indeterminate; did not violate prior antibacterials exclusion or received concomitant antibiotic therapy with activity against baseline pathogens except for patients failing study drug; or had other confounding factors that interfered with the assessment of outcome including unblinding.

Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (≥10^5 CFU/mL) is eradicated to <10^3 CFU/mL. Symptomatic clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI.

All patients who meet the criteria for the microITT population AND had a diagnosis of cUTI; received treatment for ≥48 hours; were evaluated at EOT with a response that was not indeterminate; did not violate prior antibacterials exclusion or received concomitant antibiotic therapy with activity against baseline pathogens except for patients failing study drug; or had other confounding factors that interfered with the assessment of outcome including unblinding.

Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (≥10^5 CFU/mL) is eradicated to <10^3 CFU/mL.

All patients who meet the criteria for the microITT population AND had a diagnosis of cUTI; received treatment for ≥48 hours; were evaluated at EOT with a response that was not indeterminate; did not violate prior antibacterials exclusion or received concomitant antibiotic therapy with activity against baseline pathogens except for patients failing study drug; or had other confounding factors that interfered with the assessment of outcome including unblinding.

Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (≥10^5 CFU/mL) is eradicated to <10^3 CFU/mL. Symptomatic clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI.

All patients who meet the criteria for the microITT population AND had a diagnosis of cUTI; received treatment for ≥48 hours; were evaluated at TOC with a response that was not indeterminate; did not violate prior antibacterials exclusion or received concomitant antibiotic therapy with activity against baseline pathogens except for patients failing study drug; or had other confounding factors that interfered with the assessment of outcome including unblinding.

Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (≥10^5 CFU/mL) is eradicated to <10^3 CFU/mL.

All patients who meet the criteria for the microITT population AND had a diagnosis of cUTI; received treatment for ≥48 hours; were evaluated at TOC with a response that was not indeterminate; did not violate prior antibacterials exclusion or received concomitant antibiotic therapy with activity against baseline pathogens except for patients failing study drug; or had other confounding factors that interfered with the assessment of outcome including unblinding.

Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (≥10^5 CFU/mL) is eradicated to <10^3 CFU/mL. Symptomatic clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI.

All patients who meet the criteria for the microITT population AND had a diagnosis of cUTI; received treatment for ≥48 hours; were evaluated at LFU with a response that was not indeterminate; did not violate prior antibacterials exclusion or received concomitant antibiotic therapy with activity against baseline pathogens except for patients failing study drug; or had other confounding factors that interfered with the assessment of outcome including unblinding.

Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (≥10^5 CFU/mL) is eradicated to <10^3 CFU/mL.

All patients who meet the criteria for the microITT population AND had a diagnosis of cUTI; received treatment for ≥48 hours; were evaluated at LFU with a response that was not indeterminate; did not violate prior antibacterials exclusion or received concomitant antibiotic therapy with activity against baseline pathogens except for patients failing study drug; or had other confounding factors that interfered with the assessment of outcome including unblinding.

Symptomatic clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI.

The CE analysis population consists of all patients in the ITT analysis population who had a diagnosis of cUTI; received treatment for ≥48 hours; were evaluated at EOT with a response that was not indeterminate; did not violate prior antibacterials exclusion or received concomitant antibiotic therapy with activity against baseline pathogens except for patients failing study drug; or had other confounding factors that interfered with the assessment of outcome including unblinding.

Symptomatic clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI.

The CE analysis population consists of all patients in the ITT analysis population who had a diagnosis of cUTI; received treatment for ≥48 hours; were evaluated at EOT with a response that was not indeterminate; did not violate prior antibacterials exclusion or received concomitant antibiotic therapy with activity against baseline pathogens except for patients failing study drug; or had other confounding factors that interfered with the assessment of outcome including unblinding.

Symptomatic clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI.

The CE analysis population consists of all patients in the ITT analysis population who had a diagnosis of cUTI; received treatment for ≥48 hours; were evaluated at EOT with a response that was not indeterminate; did not violate prior antibacterials exclusion or received concomitant antibiotic therapy with activity against baseline pathogens except for patients failing study drug; or had other confounding factors that interfered with the assessment of outcome including unblinding.

Symptomatic clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI.

The CE analysis population consists of all patients in the ITT analysis population who had a diagnosis of cUTI; received treatment for ≥48 hours; were evaluated at EOT with a response that was not indeterminate; did not violate prior antibacterials exclusion or received concomitant antibiotic therapy with activity against baseline pathogens except for patients failing study drug; or had other confounding factors that interfered with the assessment of outcome including unblinding.

Symptomatic clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI.

The CE analysis population consists of all patients in the ITT analysis population who had a diagnosis of cUTI; received treatment for ≥48 hours; were evaluated at EOT with a response that was not indeterminate; did not violate prior antibacterials exclusion or received concomitant antibiotic therapy with activity against baseline pathogens except for patients failing study drug; or had other confounding factors that interfered with the assessment of outcome including unblinding.

Symptomatic clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI.

The CE analysis population consists of all patients in the ITT analysis population who had a diagnosis of cUTI; received treatment for ≥48 hours; were evaluated at EOT with a response that was not indeterminate; did not violate prior antibacterials exclusion or received concomitant antibiotic therapy with activity against baseline pathogens except for patients failing study drug; or had other confounding factors that interfered with the assessment of outcome including unblinding.

Per-pathogen eradication by baseline gram-negative pathogens. The number analyzed corresponds to the number of specified pathogens. The number is the percent of the specified pathogen identified at baseline in each treatment group that had been eradicated.

The microITT analysis population consists of all patients in the ITT analysis population who had a positive study entry urine culture defined as ≥10^5 CFU/mL of a gram-negative pathogen(s) against which both cefepime/VNRX-5133 and meropenem have antibacterial activity AND those patients who had no more than 2 microorganisms identified in the study entry culture regardless of colony count.

Per-pathogen eradication by baseline gram-negative pathogens. The number analyzed corresponds to the number of specified pathogens. The number is the percent of the specified pathogen identified at baseline in each treatment group that had been eradicated.

The microITT analysis population consists of all patients in the ITT analysis population who had a positive study entry urine culture defined as ≥10^5 CFU/mL of a gram-negative pathogen(s) against which both cefepime/VNRX-5133 and meropenem have antibacterial activity AND those patients who had no more than 2 microorganisms identified in the study entry culture regardless of colony count.

Per-pathogen eradication by baseline gram-negative pathogens. The number analyzed corresponds to the number of specified pathogens. The number is the percent of the specified pathogen identified at baseline in each treatment group that had been eradicated.

The microITT analysis population consists of all patients in the ITT analysis population who had a positive study entry urine culture defined as ≥10^5 CFU/mL of a gram-negative pathogen(s) against which both cefepime/VNRX-5133 and meropenem have antibacterial activity AND those patients who had no more than 2 microorganisms identified in the study entry culture regardless of colony count.

Per-pathogen eradication by baseline gram-negative pathogens (only pathogens identified 10 or more times are reported). The number analyzed corresponds to the number of specified pathogens. The number is the percent of the specified pathogen identified at baseline in each treatment group that had been eradicated.

The microITT analysis population consists of all patients in the ITT analysis population who had a positive study entry urine culture defined as ≥10^5 CFU/mL of a gram-negative pathogen(s) against which both cefepime/VNRX-5133 and meropenem have antibacterial activity AND those patients who had no more than 2 microorganisms identified in the study entry culture regardless of colony count.

Per-pathogen eradication by baseline gram-negative pathogens (only pathogens identified 10 or more times are reported). The number analyzed corresponds to the number of specified pathogens. The number is the percent of the specified pathogen identified at baseline in each treatment group that had been eradicated.

The microITT analysis population consists of all patients in the ITT analysis population who had a positive study entry urine culture defined as ≥10^5 CFU/mL of a gram-negative pathogen(s) against which both cefepime/VNRX-5133 and meropenem have antibacterial activity AND those patients who had no more than 2 microorganisms identified in the study entry culture regardless of colony count.

Per-pathogen eradication by baseline gram-negative pathogens (only pathogens identified 10 or more times are reported). The number analyzed corresponds to the number of specified pathogens. The number is the percent of the specified pathogen identified at baseline in each treatment group that had been eradicated.

The microITT analysis population consists of all patients in the ITT analysis population who had a positive study entry urine culture defined as ≥10^5 CFU/mL of a gram-negative pathogen(s) against which both cefepime/VNRX-5133 and meropenem have antibacterial activity AND those patients who had no more than 2 microorganisms identified in the study entry culture regardless of colony count.

Per-pathogen eradication by baseline gram-negative pathogens. The number analyzed corresponds to the number of specified pathogens. The number is the percent of the specified pathogen identified at baseline in each treatment group that had been eradicated.

All patients who meet the criteria for the microITT population AND had a diagnosis of cUTI; received treatment for ≥48 hours; were evaluated at EOT with a response that was not indeterminate; did not violate prior antibacterials exclusion or received concomitant antibiotic therapy with activity against baseline pathogens except for patients failing study drug; or had other confounding factors that interfered with the assessment of outcome including unblinding.

Per-pathogen eradication by baseline gram-negative pathogens. The number analyzed corresponds to the number of specified pathogens. The number is the percent of the specified pathogen identified at baseline in each treatment group that had been eradicated.

All patients who meet the criteria for the microITT population AND had a diagnosis of cUTI; received treatment for ≥48 hours; were evaluated at TOC with a response that was not indeterminate; did not violate prior antibacterials exclusion or received concomitant antibiotic therapy with activity against baseline pathogens except for patients failing study drug; or had other confounding factors that interfered with the assessment of outcome including unblinding.

Per-pathogen eradication by baseline gram-negative pathogens. The number analyzed corresponds to the number of specified pathogens. The number is the percent of the specified pathogen identified at baseline in each treatment group that had been eradicated.

All patients who meet the criteria for the microITT population AND had a diagnosis of cUTI; received treatment for ≥48 hours; were evaluated at LFU with a response that was not indeterminate; did not violate prior antibacterials exclusion or received concomitant antibiotic therapy with activity against baseline pathogens except for patients failing study drug; or had other confounding factors that interfered with the assessment of outcome including unblinding.

Per-pathogen eradication by baseline gram-negative pathogens (only pathogens identified 10 or more times are reported). The number analyzed corresponds to the number of specified pathogens. The number is the percent of the specified pathogen identified at baseline in each treatment group that had been eradicated.

All patients who meet the criteria for the microITT population AND had a diagnosis of cUTI; received treatment for ≥48 hours; were evaluated at EOT with a response that was not indeterminate; did not violate prior antibacterials exclusion or received concomitant antibiotic therapy with activity against baseline pathogens except for patients failing study drug; or had other confounding factors that interfered with the assessment of outcome including unblinding.

Per-pathogen eradication by baseline gram-negative pathogens (only pathogens identified 10 or more times are reported). The number analyzed corresponds to the number of specified pathogens. The number is the percent of the specified pathogen identified at baseline in each treatment group that had been eradicated.

All patients who meet the criteria for the microITT population AND had a diagnosis of cUTI; received treatment for ≥48 hours; were evaluated at TOC with a response that was not indeterminate; did not violate prior antibacterials exclusion or received concomitant antibiotic therapy with activity against baseline pathogens except for patients failing study drug; or had other confounding factors that interfered with the assessment of outcome including unblinding.

Per-pathogen eradication by baseline gram-negative pathogens (only pathogens identified 10 or more times are reported). The number analyzed corresponds to the number of specified pathogens. The number is the percent of the specified pathogen identified at baseline in each treatment group that had been eradicated.

All patients who meet the criteria for the microITT population AND had a diagnosis of cUTI; received treatment for ≥48 hours; were evaluated at LFU with a response that was not indeterminate; did not violate prior antibacterials exclusion or received concomitant antibiotic therapy with activity against baseline pathogens except for patients failing study drug; or had other confounding factors that interfered with the assessment of outcome including unblinding.

Percent of participants experiencing Treatment Emergent Adverse Events (TEAE). Treatment emergent is defined as any event that starts or worsens during or after treatment.

Patients with at least one TEAE.

Percent of participants experiencing treatment emergent Serious Adverse Events (SAE).

Patients with at least one treatment-emergent SAE.