A Study to Determine the Efficacy, Safety and Tolerability of Aztreonam-Avibactam (ATM-AVI) ± Metronidazole (MTZ) Versus Meropenem (MER) ± Colistin (COL) for the Treatment of Serious Infections Due to Gram Negative Bacteria.

Clinical cure was defined as improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. Additionally, for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Clinical cure was determined by the Independent Clinical Adjudication Committee. 95% confidence interval (CI) was based on Jeffrey's method.

Time frame: At TOC visit (Day 28)

Population: The ITT analysis set included all randomized participants regardless of receipt of study drug.

Clinical cure = improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. Additionally for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Clinical cure was determined by Independent Clinical Adjudication Committee. 95% CI was based on Jeffrey's method. CE analysis set:all participants in ITT analysis set; met criteria for cIAI, or HAP/VAP; received at least 48 hours of study treatment or \<48 hours of treatment before discontinuing study drug due to AE; no concomitant antibiotics for any baseline pathogens between first dose and TOC (except protocol-allowed antibiotics); no prior antibiotics other than allowed per protocol; no important protocol deviations; no clinical outcome of indeterminate at TOC; no monomicrobial infections due to non-eligible pathogens and did not have only Gram-positive pathogens.

Time frame: At TOC visit (Day 28)

Population: Analysis was performed on CE analysis set.

Population PK predicted (AUC24,ss) for participants who received aztreonam-avibactam in studies C3601002 (NCT03329092) and C3601009 (NCT03580044). Clinical response categories included, clinical cure=improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. For cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Failure was defined as participants who met any of the following criteria like death (after receiving at least 48 hours of study treatment) and participants who received treatment with further antibiotics for the index infection. Indeterminate was defined as death (after receiving less than 48 hours of study treatment) and for cIAI participants inadequate infection source control at time of initial surgical procedure.

Time frame: 0 to 24 hours at TOC (Day 28)

Population: Analysis population included participants from PK and ITT analysis set. All participants reported under 'Overall Number of Participants Analyzed' included participants evaluable for this outcome measure and contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies participants evaluable for the specified rows.

Population PK predicted (AUC24,ss) for participants who received aztreonam-avibactam in studies C3601002 (NCT03329092) and C3601009 (NCT03580044). Clinical response categories included, clinical cure=improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. For cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Failure was defined as participants who met any of the following criteria like death (after receiving at least 48 hours of study treatment) and participants who received treatment with further antibiotics for the index infection. Indeterminate was defined as death (after receiving less than 48 hours of study treatment) and for cIAI participants inadequate infection source control at time of initial surgical procedure.

Time frame: 0 to 24 hours at TOC (Day 28)

Population: Analysis population included participants from PK and ITT analysis set. All participants reported under 'Overall Number of Participants Analyzed' included participants evaluable for this outcome measure and contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies participants evaluable for the specified rows.

Population PK predicted (AUC24,ss) for participants who received ATM-AVI in studies C3601002 (NCT03329092) and C3601009 (NCT03580044). Microbiological response included Favorable =baseline pathogens for participant had a favorable outcome. Eradication: Absence of causative pathogen from an appropriately obtained specimen at site of infection. Presumed eradication: repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure. Unfavorable=persistence, persistence with increasing MIC, or presumed persistence. Persistence= Causative organism still present from appropriately obtained specimen at site of infection. Presumed persistence= Participant assessed as a clinical failure and repeat culture of specimens were not performed/clinically indicated. Indeterminate = death (after receiving\<48 hours of study treatment) and for cIAI participants inadequate infection source control at time of initial surgical procedure.

Time frame: 0 to 24 hours At TOC (Day 28)

Population: Analysis population included participants from PK and micro-ITT analysis set. All participants reported under 'Overall Number of Participants Analyzed' included participants evaluable for this outcome measure and contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' =participants evaluable for the specified rows.

Population PK predicted (AUC24,ss) for participants who received ATM-AVI in studies C3601002 (NCT03329092) and C3601009 (NCT03580044). Microbiological response included Favorable =baseline pathogens for participant had a favorable outcome. Eradication: Absence of causative pathogen from an appropriately obtained specimen at site of infection. Presumed eradication: repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure. Unfavorable=persistence, persistence with increasing MIC, or presumed persistence. Persistence= Causative organism still present from appropriately obtained specimen at site of infection. Presumed persistence= Participant assessed as a clinical failure and repeat culture of specimens were not performed/clinically indicated. Indeterminate = death (after receiving \< 48 hours of study treatment) and for cIAI participants inadequate infection source control at time of initial surgical procedure.

Time frame: 0 to 24 hours at TOC (Day 28)

Population: Analysis population included participants from PK and micro-ITT analysis set. All participants reported under 'Overall Number of Participants Analyzed' included participants evaluable for this outcome measure and contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' =participants evaluable for the specified rows.

Population PK predicted (Cmax,ss) for participants who received aztreonam-avibactam in studies C3601002 (NCT03329092) and C3601009 (NCT03580044). Clinical response categories included, clinical cure=improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. For cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Failure was defined as participants who met any of the following criteria like death (after receiving at least 48 hours of study treatment) and participants who received treatment with further antibiotics for the index infection. Indeterminate was defined as death (after receiving less than 48 hours of study treatment) and for cIAI participants inadequate infection source control at time of initial surgical procedure.

Time frame: At TOC (Day 28)

Population: Analysis population included participants from PK and ITT analysis set. All participants reported under 'Overall Number of Participants Analyzed' included participants evaluable for this outcome measure and contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies participants evaluable for the specified rows.

Population PK predicted maximum plasma concentration for a dosing interval at steady-state (Cmax,ss) for participants who received aztreonam-avibactam in studies C3601002 (NCT03329092) and C3601009 (NCT03580044). Clinical response categories included, clinical cure=improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. For cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Failure was defined as participants who met any of the following criteria like death (after receiving at least 48 hours of study treatment) and participants who received treatment with further antibiotics for the index infection. Indeterminate was defined as death (after receiving less than 48 hours of study treatment) and for cIAI participants inadequate infection source control at time of initial surgical procedure.

Time frame: At TOC (Day 28)

Population: Analysis population included participants from PK and ITT analysis set. All participants reported under 'Overall Number of Participants Analyzed' included participants evaluable for this outcome measure and contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies participants evaluable for the specified rows.

Population PK predicted (Cmax,ss) for participants who received ATM-AVI in studies C3601002 (NCT03329092) and C3601009 (NCT03580044). Microbiological response included Favorable =baseline pathogens for participant had a favorable outcome. Eradication: Absence of causative pathogen from an appropriately obtained specimen at site of infection. Presumed eradication: repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure. Unfavorable=persistence, persistence with increasing MIC, or presumed persistence. Persistence= Causative organism still present from appropriately obtained specimen at site of infection. Presumed persistence= Participant assessed as a clinical failure and repeat culture of specimens were not performed/clinically indicated. Indeterminate = death (after receiving \< 48 hours of study treatment) and for cIAI participants inadequate infection source control at time of initial surgical procedure.

Time frame: At TOC (Day 28)

Population: Analysis population included participants from PK and micro-ITT analysis set. All participants reported under 'Overall Number of Participants Analyzed' included participants evaluable for this outcome measure and contributed data to the table but may not have evaluable data for every row. Number Analyzed=participants evaluable for the specified rows.

Population PK predicted (Cmax,ss (mg/L)) for participants who received ATM-AVI in studies C3601002 (NCT03329092) and C3601009 (NCT03580044). Microbiological response included Favorable =baseline pathogens for participant had a favorable outcome. Eradication: Absence of causative pathogen from an appropriately obtained specimen at site of infection. Presumed eradication: repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure. Unfavorable=persistence, persistence with increasing MIC, or presumed persistence. Persistence= Causative organism still present from appropriately obtained specimen at site of infection. Presumed persistence= Participant assessed as a clinical failure and repeat culture of specimens were not performed/clinically indicated. Indeterminate = death (after receiving\<48 hours of study treatment) and for cIAI participants inadequate infection source control at time of initial surgical procedure.

Time frame: At TOC (Day 28)

Population: Analysis population included participants from PK and micro-ITT analysis set. All participants reported under 'Overall Number of Participants Analyzed' included participants evaluable for this outcome measure and contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' =participants evaluable for the specified rows.

Standard 12-lead ECGs were recorded with the participants in the supine position after the participant had rested in this position for 10 minutes. Clinically significant findings were based on investigators assessment.

Time frame: Baseline (latest non-missing value before start of treatment) and Day 3

Population: The safety analysis set included all participants who received any amount of study treatment.

Vitals signs, included blood pressure and, heart rate. Blood pressure (BP) and heart rate were measured using a semiautomatic BP recording device with the participant in a supine position after at least 10 minutes of rest. Criteria for abnormalities included: Systolic BP (millimeters of mercury \[mmHg\]): value more than (\>) 150 and increase from baseline more than equal (\>= 30) or value less than (\<) 90 and decrease from baseline \>= 30; DBP: value \> 100 and increase from baseline \>=20 or Value \< 50 and decrease from baseline \>= 20; Heart Rate (beats per minute \[BPM\]): value \< 40 or \> 120.

Time frame: From start of study treatment until TOC visit (Up to Day 28)

Population: Safety analysis set included all participants who received any amount of study treatment. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for the specified rows.

A complete physical examination was performed and included an assessment of the following: general appearance including site of infection, skin, head and throat (head, eyes, ears, nose, and throat), lymph nodes, lungs, cardiovascular (CV), abdomen, musculoskeletal, and neurological systems.

Time frame: Screening, End of treatment (up to 24 hours post infusion on Day 14) and Test of Cure (Day 28)

Population: The safety analysis set included all participants who received any amount of study treatment. Here, 'Number Analyzed' signifies number of participants available for specified rows.

An adverse event (AE) was any untoward medical occurrence in a study participant administered medicinal product,; the event need not necessarily have a causal relationship with product treatment or usage. A serious adverse event (SAE) was any untoward medical occurrence at any dose that: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital abnormal/birth defect or considered an important medical event.

Time frame: From start of study treatment until end of late follow-up (Up to Day 45)

Population: Safety analysis set included all participants who received any amount of study treatment. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Albumin \< 0.5\* LLN and\> 50% decrease from baseline (DFB);\> 1.5 \* ULN and\> 50% increase from baseline (IFB). Alkaline phosphatase \< 0.5 \* LLN and\> 80% DFB;\> 3.0 \* ULN and\> 100%. Alanine and Aspartate aminotransferase \> 3.0 \* ULN and\> 100% IFB. Bicarbonate \< 0.7 \* LLN and \> 40% DFB;\> 1.3 \* ULN and\> 40% IFB. Blood urea nitrogen \< 0.2 \* LLN and \> 100% DFB; \> 3.0 \* ULN and \> 200% IFB. Calcium \< 0.7 \* LLN and \> 30% DFB;\> 1.3 \* ULN and\> 30% IFB. Chloride \< 0.8 \* LLN \>and 20% DFB; \> 1.2 \* ULN and \> 20% IFB. Creatinine \> 2.0 \* ULN and\> 100% IFB; Glucose \< 0.6 \* LLN and\> 40% DFB; \> 3.0 \* ULN and\> 200% IFB. Potassium \< 0.8 \* LLN and \> 20% DFB; \> 1.2 \* ULN and\> 20% IFB. Sodium \< 0.85 \* LLN and\> 10% DFB;\> 1.1 \* ULN and \>10% IFB. Bilirubin \> 1.5 \* ULN and \> 100% IFB.; Direct bilirubin \> 2.0 \* ULN and \> 150% IFB.

Time frame: From start of study treatment until At TOC visit (Up to Day 28)

Population: Safety analysis set included all participants who received any amount of study treatment. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants available for specified rows.

Criteria for potential clinically significant hematology results were as follows: hemoglobin, hematocrit and erythrocyte \<0.7\*lower limit of normal \[LLN\] and \>30% decrease from Baseline (DFB); \>1.3\*upper limit of normal (ULN) and \>30% increase from Baseline (IFB). Platelet count \<0.65\*LLN and \> 50% decrease from baseline; \> 1.5 \* ULN and \> 100% increase from baseline. leukocyte: \< 0.65\* LLN and \> 60% decrease from baseline; \> 1.5\* ULN and 100% increase from baseline. Neutrophils/leukocytes \< 0.65 \* LLN and \>75% decrease from baseline; \> 1.6\*ULN and \> 100% increase from baseline. Lymphocytes/leukocytes \< 0.25\* LLN and \> 75% decrease from baseline;\> 1.5\* ULN and \> 100% increase from baseline, Eosinophils/leukocytes, Monocytes/leukocytes, Basophils/leukocytes \> 4.0\* ULN and \> 300% increase from baseline.

Time frame: From start of study treatment until TOC visit (Up to Day 28)

Population: Safety analysis set included all participants who received any amount of study treatment. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants available for specified rows.

Percentage of participants who died on or before 28 days after randomization is reported in this outcome measure.

Time frame: From randomization up to 28 days

Population: The ITT analysis set included all randomized participants regardless of receipt of study drug.

Percentage of participants who died on or before 28 days after randomization is reported in this outcome measure.

Time frame: From randomization up to 28 days

Population: Micro-ITT analysis set was a subset of the ITT analysis set and included all participants who had at least 1 Gram-negative baseline pathogen from an adequate specimen obtained prior to the start of study treatment.

Clinical cure = improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. Additionally, for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Clinical cure was determined by the Independent Clinical Adjudication Committee. 95% CI was based on Jeffrey's method. CE analysis set:all participants in ITT analysis set; met criteria for cIAI, or HAP/VAP; received at least 48 hours of study treatment or \<48 hours of treatment before discontinuing study drug due to AE; no concomitant antibiotics for any baseline pathogens between first dose and TOC (except protocol-allowed antibiotics); no prior antibiotics other than allowed per protocol; no important protocol deviations; no clinical outcome of indeterminate at TOC; no monomicrobial infections due to non-eligible pathogens and did not have only Gram-positive pathogens.

Time frame: At TOC visit (Day 28)

Population: CE analysis set. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for specified rows.

Clinical cure was defined as improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. Additionally, for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Clinical cure was determined by the Independent Clinical Adjudication Committee. 95% CI was based on Jeffrey's method.

Time frame: At TOC visit (Day 28)

Population: ITT analysis set included all randomized participants regardless of receipt of study drug. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for specified rows.

Clinical cure was defined as improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. Additionally, for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Clinical cure was determined by the Independent Clinical Adjudication Committee. 95% CI was based on Jeffrey's method.

Time frame: At TOC visit (Day 28)

Population: The microbiological Intent-To-Treat (micro-ITT) analysis set was a subset of the ITT analysis set and included all participants who had at least one Gram-negative baseline pathogen from an adequate specimen obtained prior to the start of study treatment.

Clinical cure was defined as improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. Additionally, for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Clinical cure was determined by the Independent Clinical Adjudication Committee. 95% CI was based on Jeffrey's method.

Time frame: At TOC visit (Day 28)

Population: ME analysis set included all participants commonly included in both micro-ITT and CE analysis sets and included participants who had at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents.

Clinical cure was defined as improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. For cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Clinical cure was determined by the Independent Clinical Adjudication Committee.

Time frame: At TOC visit (Day 28)

Population: The ME analysis set included all participants commonly included in both micro-ITT and CE analysis sets and included participants who had at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Clinical cure was defined as improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. Additionally, for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Clinical cure was determined by the Independent Clinical Adjudication Committee.

Time frame: At TOC visit (Day 28)

Population: Micro-ITT analysis set was a subset of the ITT analysis and included all participants who had at least 1 Gram-negative baseline pathogen from an adequate specimen obtained prior to the start of study treatment. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Participants were determined to have a favorable microbiological response if all baseline pathogens for that participant had a favorable outcome (eradicated or presumed eradicated). Eradication: Absence of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication: repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure.

Time frame: At TOC Visit (Day 28)

Population: The ME analysis set included all participants commonly included in both micro-ITT and CE analysis sets and included participants who had at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents.

Participants were determined to have a favorable microbiological response if all baseline pathogens for that participant had a favorable outcome (eradicated or presumed eradicated). Eradication: Absence of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication: repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure.

Time frame: At TOC visit day (28)

Population: Micro-ITT analysis set was a subset of the ITT analysis sets and included all participants who had at least 1 Gram-negative baseline pathogen from an adequate specimen obtained prior to the start of study treatment. Participants with a per participant response of indeterminate were excluded from this analysis. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Population PK predicted (%fT\>MIC ATM of 8 mg/L) for participants who received aztreonam-avibactam in studies C3601002 (NCT03329092) and C3601009 (NCT03580044). Clinical response categories included, clinical cure=improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. For cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Failure was defined as participants who met any of the following criteria like death (after receiving at least 48 hours of study treatment) and participants who received treatment with further antibiotics for the index infection. Indeterminate was defined as death (after receiving less than 48 hours of study treatment) and for cIAI participants inadequate infection source control at time of initial surgical procedure.

Time frame: At TOC (Day 28)

Population: Analysis population included participants from PK and ITT analysis set. All participants reported under 'Overall Number of Participants Analyzed' included participants evaluable for this outcome measure and contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies participants evaluable for the specified rows.

Population PK predicted (%fT\>MIC ATM of 8 mg/L) for participants who received ATM-AVI in studies C3601002 (NCT03329092) and C3601009 (NCT03580044). Microbiological response included Favorable =baseline pathogens for participant had a favorable outcome. Eradication: Absence of causative pathogen from an appropriately obtained specimen at site of infection. Presumed eradication: repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure. Unfavorable=persistence, persistence with increasing MIC, or presumed persistence. Persistence= Causative organism still present from appropriately obtained specimen at site of infection. Presumed persistence= Participant assessed as a clinical failure and repeat culture of specimens were not performed/clinically indicated. Indeterminate = death (after receiving \< 48 hours of study treatment) and for cIAI participants inadequate infection source control at time of initial surgical procedure.

Time frame: At TOC (Day 28)

Population: Analysis population included participants from PK and micro-ITT analysis set. All participants reported under 'Overall Number of Participants Analyzed' included participants evaluable for this outcome measure and contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' =participants evaluable for the specified rows.

Population PK predicted (%fT\>CT of 2.5mg/L) for participants who received aztreonam-avibactam in studies C3601002 (NCT03329092) and C3601009 (NCT03580044). Clinical response categories included, clinical cure=improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. For cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Failure was defined as participants who met any of the following criteria like death (after receiving at least 48 hours of study treatment) and participants who received treatment with further antibiotics for the index infection. Indeterminate was defined as death (after receiving less than 48 hours of study treatment) and for cIAI participants inadequate infection source control at time of initial surgical procedure.

Time frame: At TOC (Day 28)

Population: Analysis population included participants from PK and ITT analysis set. All participants reported under 'Overall Number of Participants Analyzed' included participants evaluable for this outcome measure and contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies participants evaluable for the specified rows.

Population PK predicted (%fT\>CT of 2.5 mg/L) for participants who received ATM-AVI in studies C3601002 (NCT03329092) and C3601009 (NCT03580044). Microbiological response included Favorable =baseline pathogens for participant had a favorable outcome. Eradication: Absence of causative pathogen from an appropriately obtained specimen at site of infection. Presumed eradication: repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure. Unfavorable=persistence, persistence with increasing MIC, or presumed persistence. Persistence= Causative organism still present from appropriately obtained specimen at site of infection. Presumed persistence= Participant assessed as a clinical failure and repeat culture of specimens were not performed/clinically indicated. Indeterminate = death (after receiving \< 48 hours of study treatment) and for cIAI participants inadequate infection source control at time of initial surgical procedure.

Time frame: At TOC (Day 28)

Population: Analysis population included participants from PK and micro-ITT analysis set. All participants reported under 'Overall Number of Participants Analyzed' included participants evaluable for this outcome measure and contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' =participants evaluable for the specified rows.

Plasma concentration for avibactam according to renal function (augmented, normal and mild, moderate and severe is presented in this outcome measure. Augmented = CrCL \> 150 mL/min; Normal & Mild = CrCL \> 50 to \<=150 mL/min; Moderate = CrCL \> 30 to ≤ 50 mL/min; Severe = CrCL \> 15 to ≤ 30 mL/min.

Time frame: Anytime between 25 to 30 minutes, 3.25 to 3.5 hours, 5.5 to 6.5 hours, 7.5 to 8.5 hours post start of infusion on Day 1; 2.75 to 3 hours, 3.5 to 4.5 hours, 5 to 6 and 7 to 8 hours post start of infusion on Day 4

Population: PK analysis set included all participants who had at least 1 plasma concentration data assessment available for ATM or AVI. All participants reported under 'Overall Number of Participants Analyzed' included participants evaluable for this outcome measure and contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies participants evaluable for the specified rows.

Plasma concentration for aztreonam according to renal function (augmented, normal and mild, moderate and severe is presented in this outcome measure. Augmented = Creatinine clearance (CrCL) \> 150 milliliters per minute (mL/min); Normal & Mild = CrCL \> 50 to \<=150 mL/min; Moderate = CrCL \> 30 to ≤ 50 mL/min; Severe = CrCL \> 15 to ≤ 30 mL/min.

Time frame: Anytime between 25 to 30 minutes, 3.25 to 3.5 hours, 5.5 to 6.5 hours, 7.5 to 8.5 hours post start of infusion on Day 1; 2.75 to 3 hours, 3.5 to 4.5 hours, 5 to 6 and 7 to 8 hours post start of infusion on Day 4

Population: PK analysis set included all participants who had at least 1 plasma concentration data assessment available for ATM or AVI. All participants reported under 'Overall Number of Participants Analyzed' included participants evaluable for this outcome measure and contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies participants evaluable for the specified rows.

Duration of mechanical ventilation was defined as the total number of calendar days on which the participant required mechanical ventilation from the date of randomization up to TOC. CE analysis set: all participants in ITT analysis set; met criteria for cIAI, or HAP/VAP; received at least 48 hours of study treatment or \<48 hours of treatment before discontinuing study drug due to AE; no concomitant antibiotics for any baseline pathogens between first dose and TOC (except protocol-allowed antibiotics); no prior antibiotics other than allowed per protocol; no important protocol deviations; no clinical outcome of indeterminate at TOC; no monomicrobial infections due to non-eligible pathogens and did not have only Gram-positive pathogens.

Time frame: From randomization until TOC visit (Up to Day 28)

Population: CE analysis set. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Duration of mechanical ventilation was defined as the total number of calendar days on which the participant required mechanical ventilation from the date of randomization up to TOC.

Time frame: From randomization until TOC visit (Up to Day 28)

Population: The ITT analysis set included all randomized participants regardless of receipt of study drug. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

The duration of therapy in calendar days were calculated as follows: Date of last dose of study drug - date of first dose of study drug +1.

Time frame: From first dose of study treatment until last dose of treatment (Up to 14 days)

Population: The safety analysis set included all participants who received any amount of study treatment.

The total length of ICU stay was defined as the total number of calendar days on which the participant was in ICU for the period from date of randomization until the TOC visit. CE analysis set: all participants in ITT analysis set; met criteria for cIAI, or HAP/VAP; received at least 48 hours of study treatment or \<48 hours of treatment before discontinuing study drug due to AE; no concomitant antibiotics for any baseline pathogens between first dose and TOC (except protocol-allowed antibiotics); no prior antibiotics other than allowed per protocol; no important protocol deviations; no clinical outcome of indeterminate at TOC; no monomicrobial infections due to non-eligible pathogens and did not have only Gram-positive pathogens.

Time frame: From randomization until TOC visit (Up to Day 28)

Population: CE analysis set. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

The total length of ICU stay was defined as the total number of calendar days on which the participant was in ICU for the period from date of randomization until the TOC visit.

Time frame: From randomization until TOC visit (Up to Day 28)

Population: The ITT analysis set included all randomized participants regardless of receipt of study drug. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

CE analysis set: all participants in ITT analysis set; met criteria for cIAI, or HAP/VAP; received at least 48 hours of study treatment or \<48 hours of treatment before discontinuing study drug due to AE; no concomitant antibiotics for any baseline pathogens between first dose and TOC (except protocol-allowed antibiotics); no prior antibiotics other than allowed per protocol; no important protocol deviations; no clinical outcome of indeterminate at TOC; no monomicrobial infections due to non-eligible pathogens and did not have only Gram-positive pathogens.

Time frame: Up to Day 28

Population: CE analysis set. A composite scoring system was never developed and therefore there is no data to report for this outcome measure.

Time frame: Up to Day 28

Population: The ITT analysis set included all randomized participants regardless of receipt of study drug. A composite scoring system was never developed and therefore there is no data to report for this outcome measure.

The number of participants admitted to the ICU were reported in this outcome measure. CE analysis set: all participants in ITT analysis set; met criteria for cIAI, or HAP/VAP; received at least 48 hours of study treatment or \<48 hours of treatment before discontinuing study drug due to AE; no concomitant antibiotics for any baseline pathogens between first dose and TOC (except protocol-allowed antibiotics); no prior antibiotics other than allowed per protocol; no important protocol deviations; no clinical outcome of indeterminate at TOC; no monomicrobial infections due to non-eligible pathogens and did not have only Gram-positive pathogens.

Time frame: From randomization until TOC visit (Up to Day 28)

Population: CE analysis set.

Number of participants admitted to the ICU up to TOC were reported in this outcome measure.

Time frame: From randomization until TOC visit (Up to Day 28)

Population: The ITT analysis set included all randomized participants regardless of receipt of study drug.

Participants were determined to have a favorable microbiological response if all baseline pathogens for that participant had a favorable outcome (eradicated or presumed eradicated). Eradication: Absence of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication: repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure. Only those pathogens are reported which had more than or equal to 10 isolates for either treatment group.

Time frame: At TOC visit (Day 28)

Population: Micro-ITT analysis set is a subset of the ITT analysis set and included all participants who had at least one Gram-negative baseline pathogen from an adequate specimen obtained prior to the start of study treatment. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for specified rows.

Participants were determined to have a favorable microbiological response if all baseline pathogens for that participant had a favorable outcome (eradicated or presumed eradicated). Eradication: Absence of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication: repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure. Only those pathogens are reported which had more than or equal to 10 isolates for either treatment group.

Time frame: At EOT (Within 24 hours after last infusion on Day 14)

Population: The ME analysis set included all participants commonly included in both micro-ITT and CE analysis sets and included participants who had at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for specified rows.

Participants were determined to have a favorable microbiological response if all baseline pathogens for that participant had a favorable outcome (eradicated or presumed eradicated). Eradication: Absence of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication: repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure. Only those pathogens are reported which had more than or equal to 10 isolates for either treatment group.

Time frame: At EOT (Within 24 hours after last infusion on Day 14)

Population: Micro-ITT analysis set is a subset of the ITT analysis set and included all participants who had at least one Gram-negative baseline pathogen from an adequate specimen obtained prior to the start of study treatment. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for specified rows.

Participants were determined to have a favorable microbiological response if all baseline pathogens for that participant had a favorable outcome (eradicated or presumed eradicated). Eradication: Absence of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication: repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure. Only those pathogens are reported which had more than or equal to 10 isolates for either treatment group.

Time frame: At TOC visit (Day 28)

Population: The ME analysis set included all participants commonly included in both micro-ITT and CE analysis sets and included participants who had at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for specified rows.

Number of participants with mechanical ventilation were reported in this outcome measure. CE analysis set: all participants in ITT analysis set; met criteria for cIAI, or HAP/VAP; received at least 48 hours of study treatment or \<48 hours of treatment before discontinuing study drug due to AE; no concomitant antibiotics for any baseline pathogens between first dose and TOC (except protocol-allowed antibiotics); no prior antibiotics other than allowed per protocol; no important protocol deviations; no clinical outcome of indeterminate at TOC; no monomicrobial infections due to non-eligible pathogens and did not have only Gram-positive pathogens.

Time frame: From randomization until TOC visit (Up to Day 28)

Population: CE analysis set. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Number of participants with mechanical ventilation were reported in this outcome measure.

Time frame: From randomization until TOC visit (Up to Day 28)

Population: The ITT analysis set included all randomized participants regardless of receipt of study drug. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Unplanned surgical interventions was defined as those occurring after the initial qualifying surgical intervention and prior to the TOC visit. Number of cIAI participants with unplanned surgical intervention according to clinical response categories of cure and failure is reported in this outcome measure.

Time frame: From randomization until TOC visit (Up to Day 28)

Population: CE analysis set. All participants reported under 'Overall Number of Participants Analyzed' include participants evaluable for this outcome measure and contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for specified rows.

Unplanned surgical interventions was defined as those occurring after the initial qualifying surgical intervention and prior to the TOC visit. Number of cIAI participants with unplanned surgical intervention according to clinical response categories of cure and failure is reported in this outcome measure.

Time frame: From randomization until TOC visit (Up to Day 28)

Population: The ITT analysis set included all randomized participants regardless of receipt of study drug. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for specified rows.

Percentage of participants who died on or before 14 days from randomization is reported in this outcome measure.

Time frame: From randomization up to 14 days

Population: The ITT analysis set included all randomized participants regardless of receipt of study drug.

Clinical cure was defined as improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. Additionally, for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Clinical cure was determined by the Independent Clinical Adjudication Committee. 95% CI was based on Jeffrey's method.

Time frame: At EOT visit (Within 24 hours after last infusion on Day 14)

Population: The ITT analysis set included all randomized participants regardless of the treatment received.

Clinical cure = improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. Additionally, for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Clinical cure was determined by the Independent Clinical Adjudication Committee. 95% CI was based on Jeffrey's method. CE analysis set: all participants in ITT analysis set; met criteria for cIAI, or HAP/VAP; received at least 48 hours of study treatment or \<48 hours of treatment before discontinuing study drug due to AE; no concomitant antibiotics for any baseline pathogens between first dose and TOC (except protocol-allowed antibiotics); no prior antibiotics other than allowed per protocol; no important protocol deviations; no clinical outcome of indeterminate at TOC; no monomicrobial infections due to non-eligible pathogens and did not have only Gram-positive pathogens.

Time frame: At EOT visit (Within 24 hours after last infusion on Day 14)

Population: Analysis was performed on CE analysis set.

Clinical cure was defined as improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. Additionally, for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Clinical cure was determined by the Independent Clinical Adjudication Committee. 95% CI was based on Jeffrey's method.

Time frame: At EOT visit (Within 24 hours after last infusion on Day 14)

Population: The ME analysis set included all participants commonly included in both micro-ITT and CE analysis sets and included participants who have at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents.

Clinical cure was defined as improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. For cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Clinical cure was determined by the Independent Clinical Adjudication Committee. 95% CI was based on Jeffrey's method.

Time frame: At EOT visit (Within 24 hours after last infusion on Day 14)

Population: Micro-ITT analysis set was a subset of the ITT analysis set and included all participants who had at least one Gram-negative baseline pathogen from an adequate specimen obtained prior to the start of study treatment.

Clinical cure was defined as improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. Additionally, for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Clinical cure was determined by the Independent Clinical Adjudication Committee. Percentage of participants with clinical cure by pathogen resistance type (ATM non-susceptible and Meropenem non-susceptible based on EUCAST criteria and CLSI criteria, ESBL-positive, Carbapenemase-positive, Serene Carbapenemase and Metallo-beta-lactamase-positive) is reported in this outcome measure.

Time frame: At EOT (Within 24 hours after last infusion on Day 14)

Population: The ME analysis set included all participants commonly included in both micro-ITT and CE analysis sets and included participants who had at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for specified rows.

Clinical cure was defined as improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. Additionally, for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Clinical cure was determined by the Independent Clinical Adjudication Committee. Percentage of participants with clinical cure by pathogen resistance type (ATM non-susceptible and Meropenem non-susceptible based on European Committee on Antimicrobial Susceptibility Testing \[EUCAST\] criteria and Clinical and Laboratory Standards Institute \[CLSI\] criteria, Extended spectrum beta-lactamases \[ESBL\]-positive, Carbapenemase-positive, Serene Carbapenemase and Metallo-beta-lactamase-positive) is reported in this outcome measure.

Time frame: At EOT visit (Within 24 hours after last infusion on Day 14)

Population: Micro-ITT analysis set was a subset of the ITT analysis set and included all participants who had at least one Gram-negative baseline pathogen from an adequate specimen obtained prior to the start of study treatment. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for specified rows.

Clinical cure was defined as improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. Additionally, for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Clinical cure was determined by the Independent Clinical Adjudication Committee. Percentage of participants with clinical cure by pathogen resistance type (ATM non-susceptible and Meropenem non-susceptible based on EUCAST criteria and CLSI criteria, ESBL-positive, Carbapenemase-positive, Serene Carbapenemase and Metallo-beta-lactamase-positive) is reported in this outcome measure.

Time frame: At TOC visit (Day 28)

Population: The ME analysis set included all participants commonly included in both micro-ITT and CE analysis sets and included participants who had at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for specified rows.

Clinical cure was defined as improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. Additionally, for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Clinical cure was determined by the Independent Clinical Adjudication Committee. Percentage of participants with clinical cure by pathogen resistance type (ATM non-susceptible and Meropenem non-susceptible based on EUCAST criteria and CLSI criteria, ESBL-positive, Carbapenemase-positive, Serene Carbapenemase and Metallo-beta-lactamase-positive) is reported in this outcome measure.

Time frame: At TOC (Day 28)

Population: Micro-ITT analysis set was a subset of the ITT analysis set and included all participants who had at least one Gram-negative baseline pathogen from an adequate specimen obtained prior to the start of study treatment. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for specified rows.

Clinical cure = improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. Additionally, for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Clinical cure was determined by the Independent Clinical Adjudication Committee. 95% CI was based on Jeffrey's method. CE analysis set: all participants in ITT analysis set; met criteria for cIAI, or HAP/VAP; received at least 48 hours of study treatment or \<48 hours of treatment before discontinuing study drug due to AE; no concomitant antibiotics for any baseline pathogens between first dose and TOC (except protocol-allowed antibiotics); no prior antibiotics other than allowed per protocol; no important protocol deviations; no clinical outcome of indeterminate at TOC; no monomicrobial infections due to non-eligible pathogens and did not have only Gram-positive pathogens.

Time frame: At EOT visit (Within 24 hours after last infusion on Day 24)

Population: CE analysis set. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for specified rows.

Clinical cure was defined as improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. Additionally, for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Clinical cure was determined by the Independent Clinical Adjudication Committee. 95% CI was based on Jeffrey's method.

Time frame: At EOT visit (Within 24 hours after last infusion on Day 14)

Population: The ITT analysis set included all randomized participants regardless of the treatment received. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for specified rows.

Participants were determined to have a favorable microbiological response if all baseline pathogens for that participant had a favorable outcome (eradicated or presumed eradicated). Eradication: Absence of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication: repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure.

Time frame: At EOT visit (Within 24 hours after last infusion on Day 14)

Population: The ME analysis set included all participants commonly included in both micro-ITT and CE analysis sets and included participants who had at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents.

Participants were determined to have a favorable microbiological response if all baseline pathogens for that participant had a favorable outcome (eradicated or presumed eradicated). Eradication: Absence of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication: repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure.

Time frame: At EOT visit (Within 24 hours after last infusion on Day 14)

Population: Micro-ITT analysis set is a subset of the ITT analysis set and included all participants who had at least one Gram-negative baseline pathogen from an adequate specimen obtained prior to the start of study treatment. Participants with a per participant response of indeterminate were excluded from this analysis. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Participants were determined to have a favorable microbiological response if all baseline pathogens for that participant had a favorable outcome (eradicated or presumed eradicated). Eradication: Absence of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication: repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure. Percentage of participants with favorable microbiological response by pathogen resistance type (ATM non-susceptible, Meropenem non-susceptible based on EUCAST criteria and CLSI criteria, ESBL-positive, Carbapenemase-positive, Serene Carbapenemase and Metallo-beta-lactamase-positive) is reported in this outcome measure.

Time frame: At EOT (Within 24 hours after last infusion on Day 14)

Population: ME analysis set =all participants commonly included in both micro-ITT and CE analysis sets and included participants who had at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for specified rows.

Participants were determined to have a favorable microbiological response if all baseline pathogens for that participant had a favorable outcome (eradicated or presumed eradicated). Eradication: Absence of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication: repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure. Percentage of participants with favorable microbiological response by pathogen resistance type (ATM non-susceptible and Meropenem non-susceptible based on EUCAST criteria and CLSI criteria, ESBL-positive, Carbapenemase-positive, Serene Carbapenemase and Metallo-beta-lactamase-positive) is reported in this outcome measure.

Time frame: At EOT (Within 24 hours after last infusion on Day 14)

Population: Micro-ITT analysis set=subset of ITT analysis set \& included all participants who had at least 1 Gram-negative baseline pathogen from an adequate specimen obtained prior to start of study treatment.Here, 'Overall Number of Participants Analyzed' signifies participants included in micro-ITT analysis set and contributed data to table. Number Analyzed=number of participants evaluable for specified rows and participants with per participant response of indeterminate were excluded from analysis.

Participants were determined to have a favorable microbiological response if all baseline pathogens for that participant had a favorable outcome (eradicated or presumed eradicated). Eradication: Absence of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication: repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure. Percentage of participants with favorable microbiological response by pathogen resistance type (ATM non-susceptible, Meropenem non-susceptible based on EUCAST criteria and CLSI criteria, ESBL-positive, Carbapenemase-positive, Serene Carbapenemase and Metallo-beta-lactamase-positive) is reported in this outcome measure.

Time frame: At TOC visit (Day 28)

Population: ME analysis set =all participants commonly included in both micro-ITT and CE analysis sets and included participants who had at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for specified rows.

Participants were determined to have a favorable microbiological response if all baseline pathogens for that participant had a favorable outcome (eradicated or presumed eradicated). Eradication: Absence of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication: repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure. Percentage of participants with favorable microbiological response by pathogen resistance type (ATM non-susceptible and Meropenem non-susceptible based on EUCAST criteria and CLSI criteria, ESBL-positive, Carbapenemase-positive, Serene Carbapenemase and Metallo-beta-lactamase-positive) is reported in this outcome measure.

Time frame: At TOC visit (Day 28)

Population: Micro-ITT analysis set=subset of ITT analysis set \& included all participants who had at least 1 Gram-negative baseline pathogen from an adequate specimen obtained prior to start of study treatment. Here, 'Overall Number of Participants Analyzed' signifies participants included in micro-ITT analysis set and contributed data to table. Number Analyzed=number of participants evaluable for specified rows and participants with per participant response of indeterminate were excluded from analysis.

Participants were determined to have a favorable microbiological response if all baseline pathogens for that participant had a favorable outcome (eradicated or presumed eradicated). Eradication: Absence of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication: repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure. Percentage of participants with favorable per-pathogen microbiological response by pathogen resistance type (ATM non-susceptible, Meropenem non-susceptible based on EUCAST criteria and CLSI criteria, ESBL-positive, Carbapenemase-positive, Serene Carbapenemase and Metallo-beta-lactamase-positive) is reported in this outcome measure.

Time frame: At EOT (Within 24 hours after last infusion on Day 14)

Population: The ME analysis set included all participants commonly included in both micro-ITT and CE analysis sets and included participants who had at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for specified rows.

Participants were determined to have a favorable microbiological response if all baseline pathogens for that participant had a favorable outcome (eradicated or presumed eradicated). Eradication: Absence of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication: repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure. Percentage of participants with favorable per-pathogen microbiological response by pathogen resistance type (ATM non-susceptible, Meropenem non-susceptible based on EUCAST criteria and CLSI criteria, ESBL-positive, Carbapenemase-positive, Serene Carbapenemase and Metallo-beta-lactamase-positive) is reported in this outcome measure.

Time frame: At EOT (Within 24 hours after last infusion on Day 14)

Population: Micro-ITT analysis set is a subset of the ITT analysis set and included all participants who had at least one Gram-negative baseline pathogen from an adequate specimen obtained prior to the start of study treatment. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for specified rows.

Participants were determined to have a favorable microbiological response if all baseline pathogens for that participant had a favorable outcome (eradicated or presumed eradicated). Eradication: Absence of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication: repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure. Percentage of participants with favorable per-pathogen microbiological response by pathogen resistance type (ATM non-susceptible, Meropenem non-susceptible based on EUCAST criteria and CLSI criteria, ESBL-positive, Carbapenemase-positive, Serene Carbapenemase and Metallo-beta-lactamase-positive) is reported in this outcome measure.

Time frame: At TOC visit (Day 28)

Population: The ME analysis set included all participants commonly included in both micro-ITT and CE analysis sets and included participants who had at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for specified rows.

Participants were determined to have a favorable microbiological response if all baseline pathogens for that participant had a favorable outcome (eradicated or presumed eradicated). Eradication: Absence of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication: repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure. Percentage of participants with favorable per-pathogen microbiological response by pathogen resistance type (ATM non-susceptible, Meropenem non-susceptible based on EUCAST criteria and CLSI criteria, ESBL-positive, Carbapenemase-positive, Serene Carbapenemase and Metallo-beta-lactamase-positive) is reported in this outcome measure.

Time frame: At TOC visit (Day 28)

Population: Micro-ITT analysis set is a subset of the ITT analysis set and included all participants who had at least one Gram-negative baseline pathogen from an adequate specimen obtained prior to the start of study treatment. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for specified rows.

The total length of hospital stay was defined as the total number of calendar days on which the participant was in the hospital from the date of randomization up to and including the specified time point of TOC. CE analysis set: all participants in ITT analysis set; met criteria for cIAI, or HAP/VAP; received at least 48 hours of study treatment or \<48 hours of treatment before discontinuing study drug due to AE; no concomitant antibiotics for any baseline pathogens between first dose and TOC (except protocol-allowed antibiotics); no prior antibiotics other than allowed per protocol; no important protocol deviations; no clinical outcome of indeterminate at TOC; no monomicrobial infections due to non-eligible pathogens and did not have only Gram-positive pathogens.

Time frame: From randomization up to Day 28

Population: CE analysis set.

The total length of hospital stay was defined as the total number of calendar days on which the participant was in the hospital from the date of randomization up to and including the specified time point of TOC.

Time frame: From randomization up to Day 28

Population: The ITT analysis set included all randomized participants regardless of receipt of study drug. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.