Clinical response: Clinical response of cure was defined as complete resolution or significant improvement of signs and symptoms of the index infection such that no further antimicrobial therapy, drainage, or surgical intervention was necessary. TOC was after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion; clinical failure: Death related to intra-abdominal infection, Persisting or recurrent infection within the abdomen, Postsurgical wound infections, participant who received treatment with additional antibiotics for ongoing symptoms of intra-abdominal infection; Indeterminate: Study data was not available for evaluation of efficacy for any reason. TOC was after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion.

CE analysis set included participants who had an appropriate diagnosis of cIAI; either received therapy for greater than or equal to (>=) 48 hours, with >=80 percent (%) of the scheduled drug administered over number of days administered or received therapy less than (<) 48 hours before discontinuing treatment due to an adverse event (AE).

Clinical response: Clinical response of cure was defined as complete resolution or significant improvement of signs and symptoms of the index infection such that no further antimicrobial therapy, drainage, or surgical intervention was necessary. TOC was after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion; clinical failure: Death related to intra-abdominal infection, Persisting or recurrent infection within the abdomen, Postsurgical wound infections, participant who received treatment with additional antibiotics for ongoing symptoms of intra-abdominal infection; Indeterminate: Study data was not available for evaluation of efficacy for any reason. EOT: within 24 hours after completion of last IV infusion. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion.

CE analysis set evaluated. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Here, "Number Analyzed" signifies participants included in CE analysis set at EOT and LFU respectively.

Clinical response: Clinical response of cure was defined as complete resolution or significant improvement of signs and symptoms of the index infection such that no further antimicrobial therapy, drainage, or surgical intervention was necessary. TOC was after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion; clinical failure: Death related to intra-abdominal infection, Persisting or recurrent infection within the abdomen, Postsurgical wound infections, participant who received treatment with additional antibiotics for ongoing symptoms of intra-abdominal infection; Indeterminate: Study data was not available for evaluation of efficacy for any reason. EOT: within 24 hours after completion of last IV infusion. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion.

MITT analysis set included all enrolled participants who had clinical evidence of cIAI and received any amount of study drug.

Clinical response: Clinical response of cure was defined as complete resolution or significant improvement of signs and symptoms of the index infection such that no further antimicrobial therapy, drainage, or surgical intervention was necessary. TOC was after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion; clinical failure: Death related to intra-abdominal infection, Persisting or recurrent infection within the abdomen, Postsurgical wound infections, participant who received treatment with additional antibiotics for ongoing symptoms of intra-abdominal infection; Indeterminate: Study data was not available for evaluation of efficacy for any reason. EOT: within 24 hours after completion of last IV infusion. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion.

mMITT analysis set included all enrolled participant who met the disease definition of cIAI; received any amount of study drug and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities).

Clinical response: Clinical response of cure was defined as complete resolution or significant improvement of signs and symptoms of the index infection such that no further antimicrobial therapy, drainage, or surgical intervention was necessary. TOC was after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion; clinical failure: Death related to intra-abdominal infection, Persisting or recurrent infection within the abdomen, Postsurgical wound infections, participant who received treatment with additional antibiotics for ongoing symptoms of intra-abdominal infection; Indeterminate: Study data was not available for evaluation of efficacy for any reason. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion.

ME analysis set included participants who were included in a subset of CE participants and had at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible. Here, "Number Analyzed" signifies participants included in ME analysis set at EOT and LFU respectively.

Clinical response: Clinical response of cure was defined as complete resolution or significant improvement of signs and symptoms of the index infection such that no further antimicrobial therapy, drainage, or surgical intervention was necessary. TOC was after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion; clinical failure: Death related to intra-abdominal infection, Persisting or recurrent infection within the abdomen, Postsurgical wound infections, participant who received treatment with additional antibiotics for ongoing symptoms of intra-abdominal infection; Indeterminate: Study data was not available for evaluation of efficacy for any reason. EOT: within 24 hours after completion of last IV infusion. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion.

eME analysis set included participants who were included in a subset of CE participants and had at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that is susceptible. Here, "Number Analyzed" signifies participants included in eME analysis set at EOT and LFU respectively.

Microbiological response: Favorable microbiological response assessments include "eradication", "presumed eradication" and "colonization". Unfavorable microbiological response assessments include "persistence", "persistence with increasing MIC", and "presumed persistence. Indeterminate: Study data are not available for evaluation of efficacy. "Indeterminate" were not included in the denominator. EOT: within 24 hours after completion of last IV infusion. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion.

mMITT analysis set included all enrolled participant who met the disease definition of cIAI; received any amount of study drug and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities).

Microbiological response: Favorable microbiological response assessments include "eradication", "presumed eradication" and "colonization". Unfavorable microbiological response assessments include "persistence", "persistence with increasing MIC", and "presumed persistence. Indeterminate: Study data was not available for evaluation of efficacy. "Indeterminate" were not included in the denominator. EOT: within 24 hours after completion of last IV infusion. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion.

ME analysis set included participants who were included in a subset of CE participants and had at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible. Here, "Number Analyzed" signifies participants included in ME analysis set at EOT, TOC and LFU respectively.

Microbiological response: Favorable microbiological response assessments include "eradication", "presumed eradication" and "colonization". Unfavorable microbiological response assessments include "persistence", "persistence with increasing MIC", and "presumed persistence. Indeterminate: Study data was not available for evaluation of efficacy. "Indeterminate" were not included in the denominator. EOT: within 24 hours after completion of last IV infusion. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion.

eME analysis set included participants who were included in a subset of CE participants and had at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that is susceptible. Here, "Number Analyzed" signifies participants included in eME analysis set at EOT, TOC and LFU respectively.

Microbiological response: Favorable microbiological response assessments include "eradication", "presumed eradication" and "colonization". Unfavorable microbiological response assessments include "persistence", "persistence with increasing MIC", and "presumed persistence. Indeterminate: Study data was not available for evaluation of efficacy. "Indeterminate" were not included in the denominator. EOT: within 24 hours after completion of last IV infusion. Response of baseline pathogens cultured from intra-abdominal site or blood. A participant can have more than 1 pathogen. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion.

mMITT analysis set:all enrolled participant who met disease definition of cIAI; received any amount of study drug; had at least 1 etiologic pathogen identified at study entry."Overall Number of Participants Analyzed": participants evaluable for this outcome measure however all participants reported under 'Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row. "Number Analyzed":participants included in eME analysis set at EOT, TOC & LFU.

Microbiological response: Favorable microbiological response assessments include "eradication", "presumed eradication" and "colonization". Unfavorable microbiological response assessments include "persistence", "persistence with increasing MIC", and "presumed persistence. Indeterminate: Study data are not available for evaluation of efficacy. "Indeterminate" were not included in the denominator. EOT: within 24 hours after completion of last IV infusion. Response of baseline pathogens cultured from intra-abdominal site or blood. A participant can have more than 1 pathogen. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion.

ME analysis set: participants who were included in subset of CE participants & had at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible. "Overall Number of Participants Analyzed":participants evaluable for this outcome measure however all participants reported under 'Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row. "Number Analyzed":participants included in ME analysis set at EOT,TOC & LFU

Microbiological response: Favorable microbiological response assessments include "eradication", "presumed eradication" and "colonization". Unfavorable microbiological response assessments include "persistence", "persistence with increasing MIC", and "presumed persistence. Indeterminate: Study data was not available for evaluation of efficacy. "Indeterminate" were not included in the denominator. EOT: within 24 hours after completion of last IV infusion. Response of baseline pathogens cultured from intra-abdominal site or blood. A participant can have more than 1 pathogen. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion.

eME analysis set: participants who were included in subset of CE participants & had at least 1 Gram-negative aerobic pathogen in initial/prestudy culture that is susceptible. Overall Number of Participants Analyzed":participants evaluable for this outcome measure however all participants reported under 'Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row. "Number Analyzed": participants included in eME analysis set at EOT, TOC & LFU.

Microbiological response: Favorable microbiological response assessments include "eradication", "presumed eradication" and "colonization". Unfavorable microbiological response assessments include "persistence", "persistence with increasing MIC", and "presumed persistence. Indeterminate: Study data was not available for evaluation of efficacy. "Indeterminate" were not included in the denominator. EOT: within 24 hours after completion of last IV infusion. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion.

mMITT analysis set:all enrolled participant who met disease definition of cIAI; received any amount of study drug; had at least 1 etiologic pathogen identified at study entry."Overall Number of Participants Analyzed": participants evaluable for this outcome measure however all participants reported under 'Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row. "Number Analyzed":participants included in eME analysis set at EOT, TOC & LFU

Microbiological response: Favorable microbiological response assessments include "eradication", "presumed eradication" and "colonization". Unfavorable microbiological response assessments include "persistence", "persistence with increasing MIC", and "presumed persistence. Indeterminate: Study data was not available for evaluation of efficacy. "Indeterminate" were not included in the denominator. EOT: within 24 hours after completion of last IV infusion. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion.

ME analysis set: participants who were included in subset of CE participants & had at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible. "Overall Number of Participants Analyzed":participants evaluable for this outcome measure however all participants reported under 'Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row. "Number Analyzed":participants included in ME analysis set at EOT,TOC & LFU

Microbiological response: Favorable microbiological response assessments include "eradication", "presumed eradication" and "colonization". Unfavorable microbiological response assessments include "persistence", "persistence with increasing MIC", and "presumed persistence. Indeterminate: Study data was not available for evaluation of efficacy. "Indeterminate" were not included in the denominator. EOT: within 24 hours after completion of last IV infusion. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion.

eME analysis set: participants who were included in subset of CE participants & had at least 1 Gram-negative aerobic pathogen in initial/prestudy culture that is susceptible. Overall Number of Participants Analyzed":participants evaluable for this outcome measure however all participants reported under 'Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row. "Number Analyzed": participants included in eME analysis set at EOT, TOC & LFU.

An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. SAE was defined as any untoward medical occurrence that, at any dose that resulted in death, was life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent disability/incapacity, a congenital anomaly/birth defect as per medical or scientific judgment. AEs included both SAEs and non-SAEs. TEAE was defined as an AE that emerges or worsened during the effective duration of treatment. All events that started on or after the first dosing day were flagged as TEAEs.

Safety analysis set included all participants who received any amount of IV study intervention.

Number of participants with death is presented.

Safety analysis set included all participants who received any amount of IV study intervention.

Number of participants who discontinued treatment and study due to adverse events is presented.

Safety analysis set included all participants who received any amount of IV study intervention.

A semiautomated recording device was used to measure SBP and DBP with participant in a supine position after at least 5 minutes of rest.

Safety analysis set included all participants who received any amount of IV study intervention. Here, "Number Analyzed" signifies participants included in safety analysis set at EOT, TOC and LFU respectively. Here, "Number Analyzed" signifies number of participants evaluable for specified rows.

Pulse rate was measured for in a supine position preceded by at least 5 minutes of rest for the participant.

Safety analysis set included all participants who received any amount of IV study intervention. Here, "Number Analyzed" signifies participants included in safety analysis set at EOT, TOC and LFU respectively. Here, "Number Analyzed" signifies number of participants evaluable for specified rows.

Body weight was measured using a balance scale.

Safety analysis set included all participants who received any amount of IV study intervention. Here, "Number Analyzed" signifies participants included in safety analysis set at EOT, TOC and LFU respectively. Here, "Number Analyzed" signifies number of participants evaluable for specified rows.

Temperature was measured in a supine position, after the participant had rest for at least 5 minutes.

Safety analysis set included all participants who received any amount of IV study intervention. Here, "Number Analyzed" signifies participants included in safety analysis set at EOT, TOC and LFU respectively. Here, "Number Analyzed" signifies participants evaluable for specified rows.

Respiratory rate was measured in a supine position, after the participant had rest for at least 5 minutes.

Safety analysis set included all participants who received any amount of IV study intervention. Here, "Number Analyzed" signifies participants included in safety analysis set at EOT, TOC and LFU respectively. Here, "Number Analyzed" signifies participants evaluable for specified rows.

Criteria for abnormal laboratory values for chemistry parameters: Bilirubin >1.5*upper limit of normal (ULN), direct Bilirubin >1.5*ULN, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase >3.0*ULN, total protein and albumin <0.8*lower limit of normal (LLN), urea nitrogen and creatinine >1.3*ULN, sodium >0.95*LLN, potassium >0.9*LLN and >1.1*ULN, calcium >0.9*LLN, glucose > 1.5*LLN; hematology parameters: Hemoglobin, hematocrit, erythrocytes <0.8*LLN, platelets <0.5*LLN and > 1.75*ULN, leukocytes <0.6*LLN and <0.6*LLN, lymphocytes <0.8* LLN, lymphocytes/leukocytes <0.8* LLN and >1.2*ULN, neutrophils >1.2*ULN, neutrophils/leukocytes <0.8*LLN and >1.2* ULN, basophils/leukocytes >1.2*ULN, eosinophils >1.2*ULN, eosinophils/leukocytes >1.2*ULN, monocytes and monocytes/leukocytes >1.2*ULN; Criteria for abnormal laboratory values for urinalysis parameters: urine glucose, >=1, urine protein >=1, urine Hemoglobin>=1.

Safety analysis set included all participants who received any amount of IV study intervention.

Plasma concentrations of avibactam was measured by nominal sampling window.

Pharmacokinetic (PK) analysis set included all participants who have at least 1 plasma concentration data value available for either Ceftazidime or Avibactam. Overall number of participants analyzed signifies participants evaluable for this outcome measure. 'Number Analyzed' signifies participants evaluable for specified rows.

Plasma concentrations of ceftazidime was measured by nominal sampling window.

PK analysis set included all participants who have at least 1 plasma concentration data value available for either Ceftazidime or Avibactam. Overall number of participants analyzed signifies participants evaluable for this outcome measure. Here, "Number Analyzed" signifies participants evaluable for specified rows.

Clinical response: Clinical response of cure was defined as complete resolution or significant improvement of signs and symptoms of the index infection such that no further antimicrobial therapy, drainage, or surgical intervention was necessary. TOC was after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion; clinical failure: Death related to intra-abdominal infection, Persisting or recurrent infection within the abdomen, Postsurgical wound infections, participant who received treatment with additional antibiotics for ongoing symptoms of intra-abdominal infection; Indeterminate: Study data was not available for evaluation of efficacy for any reason. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion.

MITT analysis set included all enrolled participants who had clinical evidence of cIAI.

Clinical response: Clinical response of cure was defined as complete resolution or significant improvement of signs and symptoms of the index infection such that no further antimicrobial therapy, drainage, or surgical intervention was necessary. TOC was after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion; clinical failure: Death related to intra-abdominal infection, Persisting or recurrent infection within the abdomen, Postsurgical wound infections, participant who received treatment with additional antibiotics for ongoing symptoms of intra-abdominal infection; Indeterminate: Study data was not available for evaluation of efficacy for any reason. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion.

mMITT analysis set included all enrolled participant who met the disease definition of cIAI; received any amount of study drug and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities).

Clinical response: Clinical response of cure was defined as complete resolution or significant improvement of signs and symptoms of the index infection such that no further antimicrobial therapy, drainage, or surgical intervention was necessary. TOC was after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion; clinical failure: Death related to intra-abdominal infection, Persisting or recurrent infection within the abdomen, Postsurgical wound infections, participant who received treatment with additional antibiotics for ongoing symptoms of intra-abdominal infection; Indeterminate: Study data was not available for evaluation of efficacy for any reason. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion.

ME analysis set included participants who were included in a subset of CE participants and had at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible.

Clinical response: Clinical response of cure was defined as complete resolution or significant improvement of signs and symptoms of the index infection such that no further antimicrobial therapy, drainage, or surgical intervention was necessary. TOC was after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion; clinical failure: Death related to intra-abdominal infection, Persisting or recurrent infection within the abdomen, Postsurgical wound infections, participant who received treatment with additional antibiotics for ongoing symptoms of intra-abdominal infection; Indeterminate: Study data was not available for evaluation of efficacy for any reason. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion.

eME analysis set included participants who were included in a subset of CE participants and had at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that is susceptible.

Clinical response of cure was defined as complete resolution or significant improvement of signs & symptoms of index infection such that no further antimicrobial therapy, drainage, or surgical intervention was necessary. TOC was after 28 calendar days from day of 1st IV infusion, allowed visit window was 28¬-35 calendar days after day of 1st IV infusion; clinical failure: Death related to intra-abdominal infection, Persisting or recurrent infection within abdomen, Postsurgical wound infections, participant who received treatment with additional antibiotics for ongoing symptom of intra-abdominal infection; Indeterminate:Study data was not available for evaluation of efficacy for any reason. EOT: within 24 hours after completion of last IV infusion. LFU:after 42 calendar days from day of 1st IV infusion, allowed visit window was 42-49 calendar days from 1st IV infusion. TOC:after 28 calendar days from 1st IV infusion, allowed visit window was 28-35 calendar days after 1st IV infusion.

Sepsis participants subset included participants who satisfied clinical & microbiological criteria; total score >=2 in Sequential Organ Failure Assessment (SOFA) for intensive care unit (ICU) participants, 2 items or more in quick SOFA (qSOFA) for non-ICU participants; most relevant pathogens (aerobic Gram-negative bacteria -either Enterobacterales or aerobic Gram-negative pathogens other than Enterobacterales) isolated from blood at Baseline regardless of susceptibility.

Clinical response of cure was defined as complete resolution or significant improvement of signs & symptoms of index infection such that no further antimicrobial therapy, drainage, or surgical intervention was necessary. TOC was after 28 calendar days from day of 1st IV infusion, allowed visit window was 28¬-35 calendar days after day of 1st IV infusion; clinical failure: Death related to intra-abdominal infection, Persisting or recurrent infection within abdomen, Postsurgical wound infections, participant who received treatment with additional antibiotics for ongoing symptom of intra-abdominal infection; Indeterminate:Study data was not available for evaluation of efficacy for any reason. EOT: within 24 hours after completion of last IV infusion. LFU:after 42 calendar days from day of 1st IV infusion, allowed visit window was 42-49 calendar days from 1st IV infusion. TOC:after 28 calendar days from 1st IV infusion, allowed visit window was 28-35 calendar days after 1st IV infusion.

Sepsis evaluable participants subset: participants who satisfied both clinical and microbiological criteria; Clinical: at least one criteria at Baseline. 1) body temperature >=38 degree Celsius or <36 degree Celsius, 2) WBC >12000 cells/mm3 or <4000 cells/mm3, or immature neutrophil >10%, 3) heart rate >90 beats per minute (bpm), 4) SBP <90mmHg, 5) C-reactive protein (CRP) >=20 mg/dL. Microbiological: The most relevant pathogens isolated from blood at Baseline regardless of susceptibility.

Microbiological response: Favorable microbiological response assessments include "eradication", "presumed eradication" and "colonization". Unfavorable microbiological response assessments include "persistence", "persistence with increasing MIC", and "presumed persistence. Indeterminate: Study data are not available for evaluation of efficacy. EOT: within 24 hours after completion of last IV infusion. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion.

Sepsis participants subset included participants who satisfied clinical & microbiological criteria; total score >=2 in SOFA for ICU participants, 2 items or more in qSOFA for non-ICU participants; most relevant pathogens (aerobic Gram-negative bacteria -either Enterobacterales or aerobic Gram-negative pathogens other than Enterobacterales) isolated from blood at Baseline regardless of susceptibility.

Microbiological response: Favorable microbiological response assessments include "eradication", "presumed eradication" and "colonization". Unfavorable microbiological response assessments include "persistence", "persistence with increasing MIC", and "presumed persistence. Indeterminate: Study data are not available for evaluation of efficacy. EOT: within 24 hours after completion of last IV infusion. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion.

Sepsis evaluable participants subset: participants who satisfied both clinical and microbiological criteria. Clinical: at least 1 criteria at Baseline, 1) body temperature >=38 or <36 degree Celsius, 2) WBC >12000 or <4000 cells/mm3, or immature neutrophil >10%, 3) heart rate >90 bpm, 4) SBP <90 mmHg, 5) CRP >=20 mg/dL. Microbiological: The most relevant pathogens isolated from blood at Baseline regardless of susceptibility.

Microbiological response: Favorable microbiological response assessments include "eradication", "presumed eradication" and "colonization". Unfavorable microbiological response assessments include "persistence", "persistence with increasing MIC", and "presumed persistence. Indeterminate: Study data was not available for evaluation of efficacy. EOT: within 24 hours after completion of last IV infusion. Response of baseline pathogens cultured from intra-abdominal site or blood. A participant can have more than 1 pathogen. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion.

Sepsis participants subset: participants who satisfied clinical & microbiological criteria; total score >=2 in SOFA for ICU participants, 2 items or more in qSOFA for non-ICU participants; most relevant pathogens (aerobic Gram-negative bacteria -either Enterobacterales or aerobic Gram-negative pathogens other than Enterobacterales) isolated from blood at Baseline regardless of susceptibility. "Number Analyzed": participants included in Sepsis participants subset at EOT & LFU respectively.

Microbiological response: Favorable microbiological response assessments include "eradication", "presumed eradication" and "colonization". Unfavorable microbiological response assessments include "persistence", "persistence with increasing MIC", and "presumed persistence. Indeterminate: Study data was not available for evaluation of efficacy. EOT: within 24 hours after completion of last IV infusion. Response of baseline pathogens cultured from intra-abdominal site or blood. A participant can have more than 1 pathogen. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion.

Sepsis evaluable participants subset: participants who satisfied both clinical and microbiological criteria. Clinical: at least 1 criteria at Baseline, 1) body temperature >=38 or <36 degree Celsius, 2) WBC >12000 or <4000 cells/mm3, or immature neutrophil >10%, 3) heart rate >90 bpm, 4) SBP <90 mmHg, 5) CRP >=20 mg/dL. Microbiological: The most relevant pathogens isolated from blood at Baseline regardless of susceptibility.

Microbiological response: Favorable microbiological response assessments include "eradication", "presumed eradication" and "colonization". Unfavorable microbiological response assessments include "persistence", "persistence with increasing MIC", and "presumed persistence. Indeterminate: Study data was not available for evaluation of efficacy. EOT: within 24 hours after completion of last IV infusion. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion.

Sepsis participants subset: participants who satisfied clinical & microbiological criteria: total score >=2 in SOFA for ICU participants, 2 items or more in qSOFA for non-ICU participants; most relevant pathogens isolated from blood at Baseline regardless of susceptibility. Here, "Number Analyzed" signifies participants included in Sepsis participants subset at EOT and LFU respectively.

Microbiological response: Favorable microbiological response assessments include "eradication", "presumed eradication" and "colonization". Unfavorable microbiological response assessments include "persistence", "persistence with increasing MIC", and "presumed persistence. Indeterminate: Study data was not available for evaluation of efficacy. EOT: within 24 hours after completion of last IV infusion. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion.

Sepsis evaluable participants subset: participants who satisfied both clinical and microbiological criteria. Clinical: at least 1 criteria at Baseline, 1) body temperature >=38 or <36 degree Celsius, 2) WBC >12000 or <4000 cells/mm3, or immature neutrophil >10%, 3) heart rate >90 bpm, 4) SBP <90 mmHg, 5) CRP >=20 mg/dL. Microbiological: The most relevant pathogens isolated from blood at Baseline regardless of susceptibility.

An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. SAE was defined as any untoward medical occurrence that, at any dose that resulted in death, was life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent disability/incapacity, a congenital anomaly/birth defect as per medical or scientific judgment. AEs included both SAEs and non-SAEs. TEAE was defined as an AE that emerges or worsened during the effective duration of treatment. All events that started on or after the first dosing day were flagged as TEAEs.

Sepsis participants subset included participants who satisfied clinical & microbiological criteria; total score >=2 in SOFA for ICU participants, 2 items or more in qSOFA for non-ICU participants; most relevant pathogens (aerobic Gram-negative bacteria -either Enterobacterales or aerobic Gram-negative pathogens other than Enterobacterales) isolated from blood at Baseline regardless of susceptibility.

An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. SAE was defined as any untoward medical occurrence that, at any dose that resulted in death, was life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent disability/incapacity, a congenital anomaly/birth defect as per medical or scientific judgment. AEs included both SAEs and non-SAEs. TEAE was defined as an AE that emerges or worsened during the effective duration of treatment. All events that started on or after the first dosing day were flagged as TEAEs.

Sepsis evaluable participants subset: participants who satisfied both clinical and microbiological criteria. Clinical: at least 1 criteria at Baseline, 1) body temperature >=38 or <36 degree Celsius, 2) WBC >12000 or <4000 cells/mm3, or immature neutrophil >10%, 3) heart rate >90 bpm, 4) SBP <90 mmHg, 5) CRP >=20 mg/dL. Microbiological: The most relevant pathogens isolated from blood at Baseline regardless of susceptibility.