<clinical_study>
  <!-- This xml conforms to an XML Schema at:
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  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01726023</url>
  </required_header>
  <id_info>
    <org_study_id>D4280C00018</org_study_id>
    <secondary_id>2011-003893-97</secondary_id>
    <nct_id>NCT01726023</nct_id>
  </id_info>
  <brief_title>Compare Ceftazidime-Avibactam + Metronidazole vs Meropenem for Hospitalized Adults With Complicated Intra-Abd Infections</brief_title>
  <acronym>RECLAIM3</acronym>
  <official_title>A Phase III, Randomized, Multicenter, Double Blind, Double-Dummy, Parallel-Group, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime Avibactam Plus Metronidazole Versus Meropenem in the Treatment of Complicated Intra-Abdominal Infections In Hospitalized Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfizer</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the effects of Ceftazidime Avibactam plus&#xD;
      Metronidazole compared to Meropenem for treating hospitalized patients with complicated&#xD;
      intra-abdominal infections.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A Phase III, Randomized, Multicenter, Double Blind, Double-Dummy, Parallel-Group, Comparative&#xD;
      Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime Avibactam Plus&#xD;
      Metronidazole Versus Meropenem in the Treatment of Complicated Intra-Abdominal Infections In&#xD;
      Hospitalized Adults&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Clinically Evaluable (CE) Analysis Set.</measure>
    <time_frame>At the test of cure visit (Day 28 to35)</time_frame>
    <description>The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Microbiologically Evaluable (ME) Analysis Set.</measure>
    <time_frame>At the end of treatment (EOT) (within 24 hours after last IV dose)</time_frame>
    <description>The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Microbiologically Evaluable (ME) Analysis Set.</measure>
    <time_frame>At the test of cure (TOC) (Day 28 to 35)</time_frame>
    <description>The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Microbiologically Evaluable (ME) Analysis Set.</measure>
    <time_frame>At the late follow up (LFU) (Day 42 to 49)</time_frame>
    <description>The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.</measure>
    <time_frame>At the end of treatment (EOT) (within 24 hours after last IV dose)</time_frame>
    <description>The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.</measure>
    <time_frame>At the test of cure (TOC) (Day 28 to 35)</time_frame>
    <description>The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.</measure>
    <time_frame>At the late follow up (LFU) (Day 42 to 49)</time_frame>
    <description>The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.</measure>
    <time_frame>At the end of treatment (EOT) (within 24 hours after last IV dose)</time_frame>
    <description>The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.</measure>
    <time_frame>At the test of cure (TOC) (Day 28 to 35)</time_frame>
    <description>The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.</measure>
    <time_frame>At the late follow up (LFU) (Day 42 to 49)</time_frame>
    <description>The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Clinically Evaluable (CE) Analysis Set.</measure>
    <time_frame>At the end of treatment (EOT) (within 24 hours after last IV dose)</time_frame>
    <description>The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Clinically Evaluable (CE) Analysis Set.</measure>
    <time_frame>At late follow up (LFU) visits (Day 42 to 49)</time_frame>
    <description>The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Proportion of Patients With a Favorable Per-patient Microbiological Response at the End of Treatment (EOT) Visit in the Microbiologically Evaluable (ME) Analysis Set.</measure>
    <time_frame>At the end of treatment (EOT) (within 24 hours after last IV dose)</time_frame>
    <description>Per-patient &quot;favorable&quot; response indicates that all of the patient's baseline pathogens are &quot;eradicated&quot; or &quot;presumed eradicated&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Test of Cure (TOC) Visit in the Microbiologically Evaluable (ME) Analysis Set.</measure>
    <time_frame>At the test of cure (TOC) (Day 28 to 35)</time_frame>
    <description>Per-patient &quot;favorable&quot; response indicates that all of the patient's baseline pathogens are &quot;eradicated&quot; or &quot;presumed eradicated&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Late Follow up (LFU) Visit in the Microbiologically Evaluable (ME) Analysis Set.</measure>
    <time_frame>At the late follow up (LFU) (Day 42 to 49)</time_frame>
    <description>Per-patient &quot;favorable&quot; response indicates that all of the patient's baseline pathogens are &quot;eradicated&quot; or &quot;presumed eradicated&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Proportion of Patients With a Favorable Per-patient Microbiological Response at the End of Treatment (EOT) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.</measure>
    <time_frame>At the end of treatment (EOT) (within 24 hours after last IV dose)</time_frame>
    <description>Per-patient &quot;favorable&quot; response indicates that all of the patient's baseline pathogens are &quot;eradicated&quot; or &quot;presumed eradicated&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Test of Cure (TOC) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.</measure>
    <time_frame>At the test of cure (TOC) (Day 28 to 35)</time_frame>
    <description>Per-patient &quot;favorable&quot; response indicates that all of the patient's baseline pathogens are &quot;eradicated&quot; or &quot;presumed eradicated&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Late Follow up (LFU) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.</measure>
    <time_frame>At the late follow up (LFU) (Day 42 to 49)</time_frame>
    <description>Per-patient &quot;favorable&quot; response indicates that all of the patient's baseline pathogens are &quot;eradicated&quot; or &quot;presumed eradicated&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Proportion of Patients With a Favorable Per-patient Microbiological Response at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.</measure>
    <time_frame>At the end of treatment (EOT) (within 24 hours after last IV dose)</time_frame>
    <description>Per-patient &quot;favorable&quot; response indicates that all of the patient's baseline pathogens are &quot;eradicated&quot; or &quot;presumed eradicated&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.</measure>
    <time_frame>At the test of cure (TOC) (Day 28 to 35)</time_frame>
    <description>Per-patient &quot;favorable&quot; response indicates that all of the patient's baseline pathogens are &quot;eradicated&quot; or &quot;presumed eradicated&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.</measure>
    <time_frame>At the late follow up (LFU) (Day 42 to 49)</time_frame>
    <description>Per-patient &quot;favorable&quot; response indicates that all of the patient's baseline pathogens are &quot;eradicated&quot; or &quot;presumed eradicated&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.</measure>
    <time_frame>At the end of treatment (EOT) (within 24 hours after last IV dose)</time_frame>
    <description>The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Proportion of Favorable Per-pathogen Microbiological Response in the Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.</measure>
    <time_frame>At the test of cure (TOC) (Day 28 to 35)</time_frame>
    <description>The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Proportion of Favorable Per-pathogen Microbiological Response in the Microbiological Response at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.</measure>
    <time_frame>At the late follow up (LFU) (Day 42 to 49)</time_frame>
    <description>The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Microbiologically Evaluable (ME) Analysis Set.</measure>
    <time_frame>At the end of treatment (EOT) (within 24 hours after last IV dose)</time_frame>
    <description>The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Proportion of Favorable Per-pathogen Microbiological Response at the Test of Cure (TOC) Visit in the Microbiologically Evaluable (ME) Analysis Set.</measure>
    <time_frame>At the test of cure (TOC) (Day 28 to 35)</time_frame>
    <description>The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Proportion of Favorable Per-pathogen Microbiological Response at the Late Follow up (LFU) Visit in the Microbiologically Evaluable (ME) Analysis Set.</measure>
    <time_frame>At the late follow up (LFU) (Day 42 to 49)</time_frame>
    <description>The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.</measure>
    <time_frame>At the end of treatment (EOT) (within 24 hours after last IV dose)</time_frame>
    <description>The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Proportion of Favorable Per-pathogen Microbiological Response at the Test of Cure (TOC) Visit in the Extended Microbiologically Evaluable(ME) Analysis Set.</measure>
    <time_frame>At the test of cure (TOC) (Day 28 to 35)</time_frame>
    <description>The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Proportion of Favorable Per-pathogen Microbiological Response at the Late Follow up (LFU) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.</measure>
    <time_frame>At the late follow up (LFU) (Day 42 to 49)</time_frame>
    <description>The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Proportion of Patients With a Favorable Per Patient Microbiological Response at the Test of Cure (TOC) Visit for Patients Infected With Ceftazidime Resistant Pathogens in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.</measure>
    <time_frame>At the test of cure (TOC) (Day 28 to 35)</time_frame>
    <description>The microbiological responses as per the protocoled criteria: responses other than &quot;indeterminate&quot; were classified as &quot;favorable&quot; or &quot;unfavorable.&quot; Favorable microbiological response assessments included &quot;eradication&quot; and &quot;presumed eradication.&quot; Unfavorable microbiological response assessments included &quot;persistence,&quot; &quot;persistence with increasing minimum inhibitory concentration (MIC),&quot; and &quot;presumed persistence.&quot; Indeterminate microbiologic response assessments included cases where the clinical response was changed to indeterminate due to an SRP assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Proportion of Patients With a Favorable Per Patient Microbiological Response at the Test of Cure (TOC) Visit for Patients Infected With Ceftazidime Resistant Pathogens in the Microbiologically Evaluable (ME) Analysis Set.</measure>
    <time_frame>At the test of cure (TOC) (Day 28 to 35)</time_frame>
    <description>The microbiological responses as per the protocoled criteria: responses other than &quot;indeterminate&quot; were classified as &quot;favorable&quot; or &quot;unfavorable.&quot; Favorable microbiological response assessments included &quot;eradication&quot; and &quot;presumed eradication.&quot; Unfavorable microbiological response assessments included &quot;persistence,&quot; &quot;persistence with increasing minimum inhibitory concentration (MIC),&quot; and &quot;presumed persistence.&quot; Indeterminate microbiologic response assessments included cases where the clinical response was changed to indeterminate due to an SRP assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Proportion of Patients With a Favorable Per Patient Microbiological Response at the Test of Cure (TOC) Visit for Patients Infected With Ceftazidime Resistant Pathogens in the Extended Microbiologically Evaluable (ME) Analysis Set.</measure>
    <time_frame>At the test of cure (TOC) (Day 28 to 35)</time_frame>
    <description>The microbiological responses as per the protocoled criteria: responses other than &quot;indeterminate&quot; were classified as &quot;favorable&quot; or &quot;unfavorable.&quot; Favorable microbiological response assessments included &quot;eradication&quot; and &quot;presumed eradication.&quot; Unfavorable microbiological response assessments included &quot;persistence,&quot; &quot;persistence with increasing minimum inhibitory concentration (MIC),&quot; and &quot;presumed persistence.&quot; Indeterminate microbiologic response assessments included cases where the clinical response was changed to indeterminate due to an SRP assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Time to First Defervescence in the Clinically Evaluable (CE) Analysis Set for Patients Who Have Fever at Study Entry.</measure>
    <time_frame>while on study therapy (from Day 1 to Day 14)</time_frame>
    <description>Time to first defervescence was calculated for patients with a fever (&gt;38ºC) at baseline. Defervescence (≤37.8ºC) was defined as the absence of fever based on the highest temperature recorded on each study day. Time to first defervescence while on IV study therapy in the CE analysis set at TOC for patients who had fever at study entry is defined as time (in days) from the first dose of IV study therapy to first absence of fever.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Time to First Defervescence in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set for Patients Who Have Fever at Study Entry.</measure>
    <time_frame>while on study therapy (from Day 1 to Day 14)</time_frame>
    <description>Time to first defervescence was calculated for patients with a fever (&gt;38ºC) at baseline. Defervescence (≤37.8ºC) was defined as the absence of fever based on the highest temperature recorded on each study day. Time to first defervescence while on IV study therapy in the CE analysis set at TOC for patients who had fever at study entry is defined as time (in days) from the first dose of IV study therapy to first absence of fever.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety and Tolerability by Incidence and Severity of Adverse Events and Serious Adverse Events and Mortality.</measure>
    <time_frame>study duration (from screening to Day 49 LFU visit)</time_frame>
    <description>Adverse event data were collected from the screening/consent visit until the late follow-up visit (i.e. Day -1/0 to Day 42).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety and Tolerability by Incidence: Extent of Exposure.</measure>
    <time_frame>study duration (from screening to Day 49 LFU visit)</time_frame>
    <description>Duration of exposure is calculated as the difference between the last study therapy date and the first study therapy date converted to days plus 1 day. Actual calculated duration could be shorter or longer than a full day.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety and Tolerability: Clinical Laboratory Evaluation Hematology.</measure>
    <time_frame>study duration (from screening to Day 49 LFU visit)</time_frame>
    <description>Potentially clinically significant (PCS) post Baseline hematology values up to LFU (Safety analysis set)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety and Tolerability: Clinical Laboratory Evaluation Clinical Chemistry.</measure>
    <time_frame>study duration (from screening to Day 49 LFU visit)</time_frame>
    <description>Potentially clinically significant (PCS) post Baseline clinical chemistry values up to LFU (Safety analysis set)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety and Tolerability:ECG , QTcB and QTcF Intervals</measure>
    <time_frame>EOT visit/any observation on treatment</time_frame>
    <description>Shifts in ECG interpretation and changes in QT, QTcB, and QTcF intervals , from baseline to post baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Concentrations for Ceftazidime and Avibactam</measure>
    <time_frame>At Day 3: Anytime within 15 minutes prior to or after stopping study drug, anytime between 30 and 90 minutes after stopping study drug, anytime between 300 minutes and 360 minutes after stopping study drug.</time_frame>
    <description>Blood samples were taken from all patients on Day 3 for the pharmacokinetic evaluation of ceftazidime and avibactam plasma concentrations</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">486</enrollment>
  <condition>Complicated Intra-abdominal Infection</condition>
  <arm_group>
    <arm_group_label>Ceftazidime-Avibactam plus metronidazole</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Meropenem</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ceftazidime-avibactam</intervention_name>
    <description>Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg</description>
    <arm_group_label>Ceftazidime-Avibactam plus metronidazole</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>metronidazole</intervention_name>
    <description>Metronidazole 500mg/100ml solution for infusion</description>
    <arm_group_label>Ceftazidime-Avibactam plus metronidazole</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Meropenem</intervention_name>
    <description>Meropenem powder for solution for infusion 1000mg</description>
    <arm_group_label>Meropenem</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient must be 18 to 90 years of age, inclusive,&#xD;
&#xD;
          -  Female patients can participate if they are surgically sterilized or postmenopausal&#xD;
             for at least 1 year or her sexual partner has had a vasectomy&#xD;
&#xD;
          -  Female of childbearing potential has had normal menstrual periods for 3 months and&#xD;
             negative serum pregnancy test and agree to practice highly effective methods of birth&#xD;
             control during treatment and for at least 7 days after last dose&#xD;
&#xD;
          -  Intraoperative/postoperative enrollment with visual confirmation (presence of pus&#xD;
             within the abdominal cavity) of an intra-abdominal infection associated with&#xD;
             peritonitis&#xD;
&#xD;
          -  Confirmation of infection by surgical intervention within 24 hours of entry: evidence&#xD;
             of systemic inflammatory indicators; physical findings consistent with intra-abdominal&#xD;
             infection; supportive radiologic imaging findings of intra-abdominal infections&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient is diagnosed with traumatic bowel perforation undergoing surgery within 12&#xD;
             hours; perforation of gastroduodenal ulcers undergoing surgery within 24 hours. Other&#xD;
             intra-abdominal processes in which primary etiology is not likely to be infectious&#xD;
&#xD;
          -  Patient has abdominal wall abscess or bowel obstruction without perforation or&#xD;
             ischemic bowel without perforation&#xD;
&#xD;
          -  Patients whose surgery will include staged abdominal repair, or &quot;open abdomen&quot;&#xD;
             technique, or marsupialization&#xD;
&#xD;
          -  Patient has suspected intra-abdominal infections due to fungus, parasites, virus or&#xD;
             tuberculosis&#xD;
&#xD;
          -  Patient is considered unlikely to survive the 6- to 8-week study period or has a&#xD;
             rapidly progressive or terminal illness, including septic shock that is associated&#xD;
             with a high risk of mortality&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paul A Newell, MBBS, MRCP</last_name>
    <role>Study Director</role>
    <affiliation>AstraZeneca</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Baotou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Changsha</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Chengdu</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Chongqing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Fuzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Guangzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Guilin</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Haikou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hebei</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Jiangyin</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Liaocheng</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nan Chang</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tianjin</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Urumqi</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Wenzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Wuxi</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Xi'an</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ansan-si</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Anyang-si</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Busan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Cheongju-si</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Daejeon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Gwangju</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Jinju-si</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Wonju-si</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hanoi</city>
        <country>Vietnam</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hochiminh</city>
        <country>Vietnam</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
    <country>Korea, Republic of</country>
    <country>Vietnam</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>November 5, 2012</study_first_submitted>
  <study_first_submitted_qc>November 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 14, 2012</study_first_posted>
  <results_first_submitted>February 1, 2016</results_first_submitted>
  <results_first_submitted_qc>March 16, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">April 14, 2016</results_first_posted>
  <last_update_submitted>September 1, 2017</last_update_submitted>
  <last_update_submitted_qc>September 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ceftazidime-avibactam,</keyword>
  <keyword>Metronidazole,</keyword>
  <keyword>Meropenem,</keyword>
  <keyword>Anti-Bacterial Agents,</keyword>
  <keyword>Anti-Infective Agents,</keyword>
  <keyword>Therapeutic Uses,</keyword>
  <keyword>Pharmacologic Actions,</keyword>
  <keyword>Physiological Effects of Drugs</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Intraabdominal Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metronidazole</mesh_term>
    <mesh_term>Meropenem</mesh_term>
    <mesh_term>Ceftazidime</mesh_term>
    <mesh_term>Avibactam</mesh_term>
    <mesh_term>Avibactam, ceftazidime drug combination</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Overall, 486 patients were enrolled from 43 centers in 3 countries in this study. The first patient was enrolled on 14 January 2013 and the last patient last visit was on 14 March 2015.</recruitment_details>
      <pre_assignment_details>Of 486 enrolled patients, 42 did not meet the eligibility criteria. A further two patients were not randomized due to withdrawn consent, and one patient was not randomized due to unavailability of study drug.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Ceftazidime-Avibactam Plus Metronidazole</title>
          <description>Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion</description>
        </group>
        <group group_id="P2">
          <title>Meropenem</title>
          <description>Meropenem powder for solution for infusion 1000mg</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="219"/>
                <participants group_id="P2" count="222"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="190"/>
                <participants group_id="P2" count="196"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
                <participants group_id="P2" count="26"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other Eligibility criteria</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Baseline analysis population is MITT ; Randomized patients who received any amount of study therapy, excluding patients who received both study therapies. 9 patients were randomized but not treated, and one patient received doses of both treatments.</population>
      <group_list>
        <group group_id="B1">
          <title>Ceftazidime-Avibactam Plus Metronidazole</title>
          <description>Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion</description>
        </group>
        <group group_id="B2">
          <title>Meropenem</title>
          <description>Meropenem powder for solution for infusion 1000mg</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="214"/>
            <count group_id="B2" value="217"/>
            <count group_id="B3" value="431"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="48.5" spread="16.83"/>
                    <measurement group_id="B2" value="48.5" spread="17.43"/>
                    <measurement group_id="B3" value="48.5" spread="17.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>18-45 Years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="89"/>
                    <measurement group_id="B2" value="96"/>
                    <measurement group_id="B3" value="185"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>46-64 Years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="85"/>
                    <measurement group_id="B2" value="72"/>
                    <measurement group_id="B3" value="157"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>65-74 Years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>75-90 Years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="73"/>
                    <measurement group_id="B2" value="64"/>
                    <measurement group_id="B3" value="137"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="141"/>
                    <measurement group_id="B2" value="153"/>
                    <measurement group_id="B3" value="294"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="214"/>
                    <measurement group_id="B2" value="217"/>
                    <measurement group_id="B3" value="431"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Clinically Evaluable (CE) Analysis Set.</title>
        <description>The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.</description>
        <time_frame>At the test of cure visit (Day 28 to35)</time_frame>
        <population>The clinically evaluable (CE) analysis set included all patients who met the disease definition of cIAI and met the stringent criteria for clinical evaluation described in the protocol regarding dosing, concomitant medication, evaluation, etc.</population>
        <group_list>
          <group group_id="O1">
            <title>Ceftazidime-Avibactam Plus Metronidazole</title>
            <description>Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion</description>
          </group>
          <group group_id="O2">
            <title>Meropenem</title>
            <description>Meropenem powder for solution for infusion 1000mg</description>
          </group>
        </group_list>
        <measure>
          <title>The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Clinically Evaluable (CE) Analysis Set.</title>
          <description>The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.</description>
          <population>The clinically evaluable (CE) analysis set included all patients who met the disease definition of cIAI and met the stringent criteria for clinical evaluation described in the protocol regarding dosing, concomitant medication, evaluation, etc.</population>
          <units>Number of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="177"/>
                <count group_id="O2" value="184"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Clinical cure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="166"/>
                    <measurement group_id="O2" value="173"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Clinical failure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The Primary objective of this study was to assess the non inferiority (based on a 12.5% margin) of CAZ AVI plus metronidazole compared to meropenem alone with respect to clinical cure at the TOC visit in patients who were CE.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>The non-inferiority would be concluded if the lower limit of the 95% confidence interval (CI; corresponding to a 97.5% 1 sided lower bound) was greater than -12.5% for the primary outcome variable.</non_inferiority_desc>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>P-value for 1-sided test at test of cure (TOC) with a -12.5% non-inferiority margin, i.e. H0: diff ≤ -12.5%.</p_value_desc>
            <method>% Risk Difference (RD)</method>
            <method_desc>RD is CAZ AVI clinical cure rate minus Meropenem clinical cure rate. The CI was calculated by Miettinen and Nurminen method without adjustment.</method_desc>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>-0.20</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.53</ci_lower_limit>
            <ci_upper_limit>4.97</ci_upper_limit>
            <estimate_desc>units for RD are %</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Microbiologically Evaluable (ME) Analysis Set.</title>
        <description>The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.</description>
        <time_frame>At the end of treatment (EOT) (within 24 hours after last IV dose)</time_frame>
        <population>Microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible to both treatment groups.</population>
        <group_list>
          <group group_id="O1">
            <title>Ceftazidime-Avibactam Plus Metronidazole</title>
            <description>Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion</description>
          </group>
          <group group_id="O2">
            <title>Meropenem</title>
            <description>Meropenem powder for solution for infusion 1000mg</description>
          </group>
        </group_list>
        <measure>
          <title>The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Microbiologically Evaluable (ME) Analysis Set.</title>
          <description>The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.</description>
          <population>Microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible to both treatment groups.</population>
          <units>Number of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="106"/>
                <count group_id="O2" value="118"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Clinical cure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="103"/>
                    <measurement group_id="O2" value="113"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Clinical failure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Microbiologically Evaluable (ME) Analysis Set.</title>
        <description>The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.</description>
        <time_frame>At the test of cure (TOC) (Day 28 to 35)</time_frame>
        <population>Microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible to both treatment groups.</population>
        <group_list>
          <group group_id="O1">
            <title>Ceftazidime-Avibactam Plus Metronidazole</title>
            <description>Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion</description>
          </group>
          <group group_id="O2">
            <title>Meropenem</title>
            <description>Meropenem powder for solution for infusion 1000mg</description>
          </group>
        </group_list>
        <measure>
          <title>The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Microbiologically Evaluable (ME) Analysis Set.</title>
          <description>The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.</description>
          <population>Microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible to both treatment groups.</population>
          <units>Number of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="99"/>
                <count group_id="O2" value="113"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Clinical cure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92"/>
                    <measurement group_id="O2" value="107"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Clinical failure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Microbiologically Evaluable (ME) Analysis Set.</title>
        <description>The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.</description>
        <time_frame>At the late follow up (LFU) (Day 42 to 49)</time_frame>
        <population>Microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible to both treatment groups.</population>
        <group_list>
          <group group_id="O1">
            <title>Ceftazidime-Avibactam Plus Metronidazole</title>
            <description>Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion</description>
          </group>
          <group group_id="O2">
            <title>Meropenem</title>
            <description>Meropenem powder for solution for infusion 1000mg</description>
          </group>
        </group_list>
        <measure>
          <title>The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Microbiologically Evaluable (ME) Analysis Set.</title>
          <description>The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.</description>
          <population>Microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible to both treatment groups.</population>
          <units>Number of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="96"/>
                <count group_id="O2" value="106"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Clinical cure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89"/>
                    <measurement group_id="O2" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Clinical failure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.</title>
        <description>The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.</description>
        <time_frame>At the end of treatment (EOT) (within 24 hours after last IV dose)</time_frame>
        <population>Extended microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture regardless of susceptibility.</population>
        <group_list>
          <group group_id="O1">
            <title>Ceftazidime-Avibactam Plus Metronidazole</title>
            <description>Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion</description>
          </group>
          <group group_id="O2">
            <title>Meropenem</title>
            <description>Meropenem powder for solution for infusion 1000mg</description>
          </group>
        </group_list>
        <measure>
          <title>The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.</title>
          <description>The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.</description>
          <population>Extended microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture regardless of susceptibility.</population>
          <units>Number of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="107"/>
                <count group_id="O2" value="125"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Clinical cure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="104"/>
                    <measurement group_id="O2" value="120"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Clinical failure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.</title>
        <description>The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.</description>
        <time_frame>At the test of cure (TOC) (Day 28 to 35)</time_frame>
        <population>Extended microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture regardless of susceptibility.</population>
        <group_list>
          <group group_id="O1">
            <title>Ceftazidime-Avibactam Plus Metronidazole</title>
            <description>Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion</description>
          </group>
          <group group_id="O2">
            <title>Meropenem</title>
            <description>Meropenem powder for solution for infusion 1000mg</description>
          </group>
        </group_list>
        <measure>
          <title>The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.</title>
          <description>The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.</description>
          <population>Extended microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture regardless of susceptibility.</population>
          <units>Number of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="119"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Clinical cure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93"/>
                    <measurement group_id="O2" value="113"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Clinical failure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.</title>
        <description>The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.</description>
        <time_frame>At the late follow up (LFU) (Day 42 to 49)</time_frame>
        <population>Extended microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture regardless of susceptibility.</population>
        <group_list>
          <group group_id="O1">
            <title>Ceftazidime-Avibactam Plus Metronidazole</title>
            <description>Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion</description>
          </group>
          <group group_id="O2">
            <title>Meropenem</title>
            <description>Meropenem powder for solution for infusion 1000mg</description>
          </group>
        </group_list>
        <measure>
          <title>The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.</title>
          <description>The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.</description>
          <population>Extended microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture regardless of susceptibility.</population>
          <units>Number of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="97"/>
                <count group_id="O2" value="112"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Clinical cure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90"/>
                    <measurement group_id="O2" value="106"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Clinical failure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.</title>
        <description>The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.</description>
        <time_frame>At the end of treatment (EOT) (within 24 hours after last IV dose)</time_frame>
        <population>The microbiological modified intent-to-treat mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.</population>
        <group_list>
          <group group_id="O1">
            <title>Ceftazidime-Avibactam Plus Metronidazole</title>
            <description>Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion</description>
          </group>
          <group group_id="O2">
            <title>Meropenem</title>
            <description>Meropenem powder for solution for infusion 1000mg</description>
          </group>
        </group_list>
        <measure>
          <title>The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.</title>
          <description>The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.</description>
          <population>The microbiological modified intent-to-treat mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.</population>
          <units>Number of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="143"/>
                <count group_id="O2" value="152"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Clinical cure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="126"/>
                    <measurement group_id="O2" value="140"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Clinical failure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Indeterminate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.</title>
        <description>The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.</description>
        <time_frame>At the test of cure (TOC) (Day 28 to 35)</time_frame>
        <population>The microbiological modified intent-to-treat mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.</population>
        <group_list>
          <group group_id="O1">
            <title>Ceftazidime-Avibactam Plus Metronidazole</title>
            <description>Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion</description>
          </group>
          <group group_id="O2">
            <title>Meropenem</title>
            <description>Meropenem powder for solution for infusion 1000mg</description>
          </group>
        </group_list>
        <measure>
          <title>The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.</title>
          <description>The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.</description>
          <population>The microbiological modified intent-to-treat mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.</population>
          <units>Number of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="143"/>
                <count group_id="O2" value="152"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Clinical cure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="119"/>
                    <measurement group_id="O2" value="135"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Clinical failure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Indeterminate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.</title>
        <description>The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.</description>
        <time_frame>At the late follow up (LFU) (Day 42 to 49)</time_frame>
        <population>The microbiological modified intent-to-treat mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.</population>
        <group_list>
          <group group_id="O1">
            <title>Ceftazidime-Avibactam Plus Metronidazole</title>
            <description>Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion</description>
          </group>
          <group group_id="O2">
            <title>Meropenem</title>
            <description>Meropenem powder for solution for infusion 1000mg</description>
          </group>
        </group_list>
        <measure>
          <title>The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.</title>
          <description>The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.</description>
          <population>The microbiological modified intent-to-treat mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.</population>
          <units>Number of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="143"/>
                <count group_id="O2" value="152"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Clinical cure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="116"/>
                    <measurement group_id="O2" value="132"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Clinical failure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Indeterminate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Clinically Evaluable (CE) Analysis Set.</title>
        <description>The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.</description>
        <time_frame>At the end of treatment (EOT) (within 24 hours after last IV dose)</time_frame>
        <population>The clinically evaluable (CE) analysis set included all patients who met the disease definition of cIAI and met the stringent criteria for clinical evaluation described in the protocol regarding dosing, concomitant medication, evaluation, etc.</population>
        <group_list>
          <group group_id="O1">
            <title>Ceftazidime-Avibactam Plus Metronidazole</title>
            <description>Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion</description>
          </group>
          <group group_id="O2">
            <title>Meropenem</title>
            <description>Meropenem powder for solution for infusion 1000mg</description>
          </group>
        </group_list>
        <measure>
          <title>The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Clinically Evaluable (CE) Analysis Set.</title>
          <description>The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.</description>
          <population>The clinically evaluable (CE) analysis set included all patients who met the disease definition of cIAI and met the stringent criteria for clinical evaluation described in the protocol regarding dosing, concomitant medication, evaluation, etc.</population>
          <units>Number of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="190"/>
                <count group_id="O2" value="196"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Clinical cure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="183"/>
                    <measurement group_id="O2" value="187"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Clinical failure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Clinically Evaluable (CE) Analysis Set.</title>
        <description>The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.</description>
        <time_frame>At late follow up (LFU) visits (Day 42 to 49)</time_frame>
        <population>The clinically evaluable (CE) analysis set included all patients who met the disease definition of cIAI and met the stringent criteria for clinical evaluation described in the protocol regarding dosing, concomitant medication, evaluation, etc.</population>
        <group_list>
          <group group_id="O1">
            <title>Ceftazidime-Avibactam Plus Metronidazole</title>
            <description>Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion</description>
          </group>
          <group group_id="O2">
            <title>Meropenem</title>
            <description>Meropenem powder for solution for infusion 1000mg</description>
          </group>
        </group_list>
        <measure>
          <title>The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Clinically Evaluable (CE) Analysis Set.</title>
          <description>The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.</description>
          <population>The clinically evaluable (CE) analysis set included all patients who met the disease definition of cIAI and met the stringent criteria for clinical evaluation described in the protocol regarding dosing, concomitant medication, evaluation, etc.</population>
          <units>Number of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="168"/>
                <count group_id="O2" value="179"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Clinical cure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="157"/>
                    <measurement group_id="O2" value="168"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Clinical failure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Proportion of Patients With a Favorable Per-patient Microbiological Response at the End of Treatment (EOT) Visit in the Microbiologically Evaluable (ME) Analysis Set.</title>
        <description>Per-patient &quot;favorable&quot; response indicates that all of the patient's baseline pathogens are &quot;eradicated&quot; or &quot;presumed eradicated&quot;.</description>
        <time_frame>At the end of treatment (EOT) (within 24 hours after last IV dose)</time_frame>
        <population>Microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible to both treatment groups.</population>
        <group_list>
          <group group_id="O1">
            <title>Ceftazidime-Avibactam Plus Metronidazole</title>
            <description>Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion</description>
          </group>
          <group group_id="O2">
            <title>Meropenem</title>
            <description>Meropenem powder for solution for infusion 1000mg</description>
          </group>
        </group_list>
        <measure>
          <title>The Proportion of Patients With a Favorable Per-patient Microbiological Response at the End of Treatment (EOT) Visit in the Microbiologically Evaluable (ME) Analysis Set.</title>
          <description>Per-patient &quot;favorable&quot; response indicates that all of the patient's baseline pathogens are &quot;eradicated&quot; or &quot;presumed eradicated&quot;.</description>
          <population>Microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible to both treatment groups.</population>
          <units>Number of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="106"/>
                <count group_id="O2" value="118"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Favorable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="103"/>
                    <measurement group_id="O2" value="113"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unfavorable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Test of Cure (TOC) Visit in the Microbiologically Evaluable (ME) Analysis Set.</title>
        <description>Per-patient &quot;favorable&quot; response indicates that all of the patient's baseline pathogens are &quot;eradicated&quot; or &quot;presumed eradicated&quot;.</description>
        <time_frame>At the test of cure (TOC) (Day 28 to 35)</time_frame>
        <population>Microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible to both treatment groups.</population>
        <group_list>
          <group group_id="O1">
            <title>Ceftazidime-Avibactam Plus Metronidazole</title>
            <description>Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion</description>
          </group>
          <group group_id="O2">
            <title>Meropenem</title>
            <description>Meropenem powder for solution for infusion 1000mg</description>
          </group>
        </group_list>
        <measure>
          <title>The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Test of Cure (TOC) Visit in the Microbiologically Evaluable (ME) Analysis Set.</title>
          <description>Per-patient &quot;favorable&quot; response indicates that all of the patient's baseline pathogens are &quot;eradicated&quot; or &quot;presumed eradicated&quot;.</description>
          <population>Microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible to both treatment groups.</population>
          <units>Number of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="99"/>
                <count group_id="O2" value="113"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Favorable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92"/>
                    <measurement group_id="O2" value="107"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unfavorable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Late Follow up (LFU) Visit in the Microbiologically Evaluable (ME) Analysis Set.</title>
        <description>Per-patient &quot;favorable&quot; response indicates that all of the patient's baseline pathogens are &quot;eradicated&quot; or &quot;presumed eradicated&quot;.</description>
        <time_frame>At the late follow up (LFU) (Day 42 to 49)</time_frame>
        <population>Microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible to both treatment groups.</population>
        <group_list>
          <group group_id="O1">
            <title>Ceftazidime-Avibactam Plus Metronidazole</title>
            <description>Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion</description>
          </group>
          <group group_id="O2">
            <title>Meropenem</title>
            <description>Meropenem powder for solution for infusion 1000mg</description>
          </group>
        </group_list>
        <measure>
          <title>The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Late Follow up (LFU) Visit in the Microbiologically Evaluable (ME) Analysis Set.</title>
          <description>Per-patient &quot;favorable&quot; response indicates that all of the patient's baseline pathogens are &quot;eradicated&quot; or &quot;presumed eradicated&quot;.</description>
          <population>Microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible to both treatment groups.</population>
          <units>Number of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="96"/>
                <count group_id="O2" value="106"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Favorable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89"/>
                    <measurement group_id="O2" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unfavorable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Proportion of Patients With a Favorable Per-patient Microbiological Response at the End of Treatment (EOT) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.</title>
        <description>Per-patient &quot;favorable&quot; response indicates that all of the patient's baseline pathogens are &quot;eradicated&quot; or &quot;presumed eradicated&quot;.</description>
        <time_frame>At the end of treatment (EOT) (within 24 hours after last IV dose)</time_frame>
        <population>Extended microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture regardless of susceptibility.</population>
        <group_list>
          <group group_id="O1">
            <title>Ceftazidime-Avibactam Plus Metronidazole</title>
            <description>Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion</description>
          </group>
          <group group_id="O2">
            <title>Meropenem</title>
            <description>Meropenem powder for solution for infusion 1000mg</description>
          </group>
        </group_list>
        <measure>
          <title>The Proportion of Patients With a Favorable Per-patient Microbiological Response at the End of Treatment (EOT) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.</title>
          <description>Per-patient &quot;favorable&quot; response indicates that all of the patient's baseline pathogens are &quot;eradicated&quot; or &quot;presumed eradicated&quot;.</description>
          <population>Extended microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture regardless of susceptibility.</population>
          <units>Number of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="107"/>
                <count group_id="O2" value="125"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Favorable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="104"/>
                    <measurement group_id="O2" value="120"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unfavorable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Test of Cure (TOC) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.</title>
        <description>Per-patient &quot;favorable&quot; response indicates that all of the patient's baseline pathogens are &quot;eradicated&quot; or &quot;presumed eradicated&quot;.</description>
        <time_frame>At the test of cure (TOC) (Day 28 to 35)</time_frame>
        <population>Extended microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture regardless of susceptibility.</population>
        <group_list>
          <group group_id="O1">
            <title>Ceftazidime-Avibactam Plus Metronidazole</title>
            <description>Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion</description>
          </group>
          <group group_id="O2">
            <title>Meropenem</title>
            <description>Meropenem powder for solution for infusion 1000mg</description>
          </group>
        </group_list>
        <measure>
          <title>The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Test of Cure (TOC) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.</title>
          <description>Per-patient &quot;favorable&quot; response indicates that all of the patient's baseline pathogens are &quot;eradicated&quot; or &quot;presumed eradicated&quot;.</description>
          <population>Extended microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture regardless of susceptibility.</population>
          <units>Number of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="119"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Favorable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93"/>
                    <measurement group_id="O2" value="113"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unfavorable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Late Follow up (LFU) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.</title>
        <description>Per-patient &quot;favorable&quot; response indicates that all of the patient's baseline pathogens are &quot;eradicated&quot; or &quot;presumed eradicated&quot;.</description>
        <time_frame>At the late follow up (LFU) (Day 42 to 49)</time_frame>
        <population>Extended microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture regardless of susceptibility.</population>
        <group_list>
          <group group_id="O1">
            <title>Ceftazidime-Avibactam Plus Metronidazole</title>
            <description>Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion</description>
          </group>
          <group group_id="O2">
            <title>Meropenem</title>
            <description>Meropenem powder for solution for infusion 1000mg</description>
          </group>
        </group_list>
        <measure>
          <title>The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Late Follow up (LFU) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.</title>
          <description>Per-patient &quot;favorable&quot; response indicates that all of the patient's baseline pathogens are &quot;eradicated&quot; or &quot;presumed eradicated&quot;.</description>
          <population>Extended microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture regardless of susceptibility.</population>
          <units>Number of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="97"/>
                <count group_id="O2" value="112"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Favorable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90"/>
                    <measurement group_id="O2" value="106"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unfavorable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Proportion of Patients With a Favorable Per-patient Microbiological Response at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.</title>
        <description>Per-patient &quot;favorable&quot; response indicates that all of the patient's baseline pathogens are &quot;eradicated&quot; or &quot;presumed eradicated&quot;.</description>
        <time_frame>At the end of treatment (EOT) (within 24 hours after last IV dose)</time_frame>
        <population>The microbiological modified intent-to-treat (mMITT) analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.</population>
        <group_list>
          <group group_id="O1">
            <title>Ceftazidime-Avibactam Plus Metronidazole</title>
            <description>Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion</description>
          </group>
          <group group_id="O2">
            <title>Meropenem</title>
            <description>Meropenem powder for solution for infusion 1000mg</description>
          </group>
        </group_list>
        <measure>
          <title>The Proportion of Patients With a Favorable Per-patient Microbiological Response at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.</title>
          <description>Per-patient &quot;favorable&quot; response indicates that all of the patient's baseline pathogens are &quot;eradicated&quot; or &quot;presumed eradicated&quot;.</description>
          <population>The microbiological modified intent-to-treat (mMITT) analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.</population>
          <units>Number of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="143"/>
                <count group_id="O2" value="152"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Favorable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="126"/>
                    <measurement group_id="O2" value="140"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unfavorable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Indeterminate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.</title>
        <description>Per-patient &quot;favorable&quot; response indicates that all of the patient's baseline pathogens are &quot;eradicated&quot; or &quot;presumed eradicated&quot;.</description>
        <time_frame>At the test of cure (TOC) (Day 28 to 35)</time_frame>
        <population>The microbiological modified intent-to-treat (mMITT) analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.</population>
        <group_list>
          <group group_id="O1">
            <title>Ceftazidime-Avibactam Plus Metronidazole</title>
            <description>Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion</description>
          </group>
          <group group_id="O2">
            <title>Meropenem</title>
            <description>Meropenem powder for solution for infusion 1000mg</description>
          </group>
        </group_list>
        <measure>
          <title>The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.</title>
          <description>Per-patient &quot;favorable&quot; response indicates that all of the patient's baseline pathogens are &quot;eradicated&quot; or &quot;presumed eradicated&quot;.</description>
          <population>The microbiological modified intent-to-treat (mMITT) analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.</population>
          <units>Number of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="143"/>
                <count group_id="O2" value="152"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Favorable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="119"/>
                    <measurement group_id="O2" value="135"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unfavorable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Indeterminate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.</title>
        <description>Per-patient &quot;favorable&quot; response indicates that all of the patient's baseline pathogens are &quot;eradicated&quot; or &quot;presumed eradicated&quot;.</description>
        <time_frame>At the late follow up (LFU) (Day 42 to 49)</time_frame>
        <population>The microbiological modified intent-to-treat (mMITT) analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.</population>
        <group_list>
          <group group_id="O1">
            <title>Ceftazidime-Avibactam Plus Metronidazole</title>
            <description>Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion</description>
          </group>
          <group group_id="O2">
            <title>Meropenem</title>
            <description>Meropenem powder for solution for infusion 1000mg</description>
          </group>
        </group_list>
        <measure>
          <title>The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.</title>
          <description>Per-patient &quot;favorable&quot; response indicates that all of the patient's baseline pathogens are &quot;eradicated&quot; or &quot;presumed eradicated&quot;.</description>
          <population>The microbiological modified intent-to-treat (mMITT) analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.</population>
          <units>Number of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="143"/>
                <count group_id="O2" value="152"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Favorable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="116"/>
                    <measurement group_id="O2" value="132"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unfavorable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Indeterminate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.</title>
        <description>The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.</description>
        <time_frame>At the end of treatment (EOT) (within 24 hours after last IV dose)</time_frame>
        <population>The mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.</population>
        <group_list>
          <group group_id="O1">
            <title>Ceftazidime-Avibactam Plus Metronidazole</title>
            <description>Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion (summary only shows pathogens where N&gt;/=10)</description>
          </group>
          <group group_id="O2">
            <title>Meropenem</title>
            <description>Meropenem powder for solution for infusion 1000mg</description>
          </group>
        </group_list>
        <measure>
          <title>The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.</title>
          <description>The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.</description>
          <population>The mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.</population>
          <units>Participants with favorable responses</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="143"/>
                <count group_id="O2" value="152"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Escherichia coli (n=84, 89)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77"/>
                    <measurement group_id="O2" value="86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Klebsiella oxytoca (n=5, 5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Klebsiella pneumoniae (n=28,35)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pseudomonas aeruginosa (n=17, 20)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Streptococcus anginosus grou (n=8, 7)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Streptococcus mitis group (n=6, 5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Enterococcus faecalis (n=6, 6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Enterococcus faecium (n=4, 7)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Proportion of Favorable Per-pathogen Microbiological Response in the Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.</title>
        <description>The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.</description>
        <time_frame>At the test of cure (TOC) (Day 28 to 35)</time_frame>
        <population>The mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.</population>
        <group_list>
          <group group_id="O1">
            <title>Ceftazidime-Avibactam Plus Metronidazole</title>
            <description>Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion (summary only shows pathogens where N&gt;/=10)</description>
          </group>
          <group group_id="O2">
            <title>Meropenem</title>
            <description>Meropenem powder for solution for infusion 1000mg</description>
          </group>
        </group_list>
        <measure>
          <title>The Proportion of Favorable Per-pathogen Microbiological Response in the Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.</title>
          <description>The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.</description>
          <population>The mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.</population>
          <units>Participants with favorable responses</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="143"/>
                <count group_id="O2" value="152"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Escherichia coli (n=84, 89)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70"/>
                    <measurement group_id="O2" value="84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Klebsiella oxytoca (n=5, 5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Klebsiella pneumoniae (n=28,35)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pseudomonas aeruginosa (n=17, 20)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Streptococcus anginosus group (n=8, 7)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Streptococcus mitis group (n=6, 5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Enterococcus faecalis (n=6, 6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Enterococcus faecium (n=4, 7)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Proportion of Favorable Per-pathogen Microbiological Response in the Microbiological Response at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.</title>
        <description>The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.</description>
        <time_frame>At the late follow up (LFU) (Day 42 to 49)</time_frame>
        <population>The mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.</population>
        <group_list>
          <group group_id="O1">
            <title>Ceftazidime-Avibactam Plus Metronidazole</title>
            <description>Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion (summary only shows pathogens where N&gt;/=10)</description>
          </group>
          <group group_id="O2">
            <title>Meropenem</title>
            <description>Meropenem powder for solution for infusion 1000mg</description>
          </group>
        </group_list>
        <measure>
          <title>The Proportion of Favorable Per-pathogen Microbiological Response in the Microbiological Response at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.</title>
          <description>The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.</description>
          <population>The mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.</population>
          <units>Participants with favorable responses</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="143"/>
                <count group_id="O2" value="152"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Escherichia coli (n=84, 89)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70"/>
                    <measurement group_id="O2" value="82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Klebsiella pneumoniae (n=28, 35)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pseudomonas aeruginosa (n=17, 20)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Klebsiella oxytoca (n=5, 5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Enterococcus faecalis (n=6, 6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Enterococcus faecium (n=4, 7)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Streptococcus anginosus group (n=8, 7)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Streptococcus mitis group (n=6, 5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Microbiologically Evaluable (ME) Analysis Set.</title>
        <description>The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.</description>
        <time_frame>At the end of treatment (EOT) (within 24 hours after last IV dose)</time_frame>
        <population>Microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible to both treatment groups.</population>
        <group_list>
          <group group_id="O1">
            <title>Ceftazidime-Avibactam Plus Metronidazole</title>
            <description>Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion (summary only shows pathogens where N&gt;/=10)</description>
          </group>
          <group group_id="O2">
            <title>Meropenem</title>
            <description>Meropenem powder for solution for infusion 1000mg</description>
          </group>
        </group_list>
        <measure>
          <title>The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Microbiologically Evaluable (ME) Analysis Set.</title>
          <description>The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.</description>
          <population>Microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible to both treatment groups.</population>
          <units>Participants with favorable responses</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="99"/>
                <count group_id="O2" value="113"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Escherichia coli (n=69, 77)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68"/>
                    <measurement group_id="O2" value="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Klebsiella oxytoca (n=5, 5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Klebsiella pneumoniae (n=22, 29)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pseudomonas aeruginosa (n=14, 16)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Proportion of Favorable Per-pathogen Microbiological Response at the Test of Cure (TOC) Visit in the Microbiologically Evaluable (ME) Analysis Set.</title>
        <description>The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.</description>
        <time_frame>At the test of cure (TOC) (Day 28 to 35)</time_frame>
        <population>Microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible to both treatment groups.</population>
        <group_list>
          <group group_id="O1">
            <title>Ceftazidime-Avibactam Plus Metronidazole</title>
            <description>Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion (summary only shows pathogens where N&gt;/=10)</description>
          </group>
          <group group_id="O2">
            <title>Meropenem</title>
            <description>Meropenem powder for solution for infusion 1000mg</description>
          </group>
        </group_list>
        <measure>
          <title>The Proportion of Favorable Per-pathogen Microbiological Response at the Test of Cure (TOC) Visit in the Microbiologically Evaluable (ME) Analysis Set.</title>
          <description>The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.</description>
          <population>Microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible to both treatment groups.</population>
          <units>Participants with favorable responses</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="99"/>
                <count group_id="O2" value="113"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Escherichia coli (n=69, 77)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64"/>
                    <measurement group_id="O2" value="74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Klebsiella oxytoca (n=5, 5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Klebsiella pneumoniae (n=22, 29)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pseudomonas aeruginosa (n=14, 16)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Proportion of Favorable Per-pathogen Microbiological Response at the Late Follow up (LFU) Visit in the Microbiologically Evaluable (ME) Analysis Set.</title>
        <description>The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.</description>
        <time_frame>At the late follow up (LFU) (Day 42 to 49)</time_frame>
        <population>Microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible to both treatment groups.</population>
        <group_list>
          <group group_id="O1">
            <title>Ceftazidime-Avibactam Plus Metronidazole</title>
            <description>Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion (summary only shows pathogens where N&gt;/=10)</description>
          </group>
          <group group_id="O2">
            <title>Meropenem</title>
            <description>Meropenem powder for solution for infusion 1000mg</description>
          </group>
        </group_list>
        <measure>
          <title>The Proportion of Favorable Per-pathogen Microbiological Response at the Late Follow up (LFU) Visit in the Microbiologically Evaluable (ME) Analysis Set.</title>
          <description>The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.</description>
          <population>Microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible to both treatment groups.</population>
          <units>Participants with favorable responses</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="99"/>
                <count group_id="O2" value="113"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Escherichia coli (n=69, 77)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63"/>
                    <measurement group_id="O2" value="72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Klebsiella oxytoca (n=5, 5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Klebsiella pneumoniae (n=22, 29)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pseudomonas aeruginosa (n=14, 16)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.</title>
        <description>The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.</description>
        <time_frame>At the end of treatment (EOT) (within 24 hours after last IV dose)</time_frame>
        <population>Extended microbiologically evaluable(ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture regardless of susceptibility.</population>
        <group_list>
          <group group_id="O1">
            <title>Ceftazidime-Avibactam Plus Metronidazole</title>
            <description>Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion (summary only shows pathogens where N&gt;/=10)</description>
          </group>
          <group group_id="O2">
            <title>Meropenem</title>
            <description>Meropenem powder for solution for infusion 1000mg</description>
          </group>
        </group_list>
        <measure>
          <title>The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.</title>
          <description>The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.</description>
          <population>Extended microbiologically evaluable(ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture regardless of susceptibility.</population>
          <units>Participants with favorable responses</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="119"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Escherichia coli (n=70, 80)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69"/>
                    <measurement group_id="O2" value="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Klebsiella oxytoca (n=5, 5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Klebsiella pneumoniae (n=22, 30)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pseudomonas aeruginosa (n=14, 18)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Proportion of Favorable Per-pathogen Microbiological Response at the Test of Cure (TOC) Visit in the Extended Microbiologically Evaluable(ME) Analysis Set.</title>
        <description>The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.</description>
        <time_frame>At the test of cure (TOC) (Day 28 to 35)</time_frame>
        <population>Extended microbiologically evaluable(ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture regardless of susceptibility.</population>
        <group_list>
          <group group_id="O1">
            <title>Ceftazidime-Avibactam Plus Metronidazole</title>
            <description>Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion (summary only shows pathogens where N&gt;/=10)</description>
          </group>
          <group group_id="O2">
            <title>Meropenem</title>
            <description>Meropenem powder for solution for infusion 1000mg</description>
          </group>
        </group_list>
        <measure>
          <title>The Proportion of Favorable Per-pathogen Microbiological Response at the Test of Cure (TOC) Visit in the Extended Microbiologically Evaluable(ME) Analysis Set.</title>
          <description>The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.</description>
          <population>Extended microbiologically evaluable(ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture regardless of susceptibility.</population>
          <units>Participants with favorable responses</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="119"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Escherichia coli (n=70, 80)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65"/>
                    <measurement group_id="O2" value="77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Klebsiella oxytoca (n=5, 5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Klebsiella pneumoniae (n=22, 30)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pseudomonas aeruginosa (n=14, 18)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Proportion of Favorable Per-pathogen Microbiological Response at the Late Follow up (LFU) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.</title>
        <description>The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.</description>
        <time_frame>At the late follow up (LFU) (Day 42 to 49)</time_frame>
        <population>Extended microbiologically evaluable(ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture regardless of susceptibility.</population>
        <group_list>
          <group group_id="O1">
            <title>Ceftazidime-Avibactam Plus Metronidazole</title>
            <description>Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion (summary only shows pathogens where N&gt;/=10)</description>
          </group>
          <group group_id="O2">
            <title>Meropenem</title>
            <description>Meropenem powder for solution for infusion 1000mg</description>
          </group>
        </group_list>
        <measure>
          <title>The Proportion of Favorable Per-pathogen Microbiological Response at the Late Follow up (LFU) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.</title>
          <description>The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.</description>
          <population>Extended microbiologically evaluable(ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture regardless of susceptibility.</population>
          <units>Participants with favorable responses</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="119"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Escherichia coli (n=70, 80)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64"/>
                    <measurement group_id="O2" value="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Klebsiella oxytoca (n=5, 5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Klebsiella pneumoniae (n=22, 30)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pseudomonas aeruginosa (n=14, 18)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Proportion of Patients With a Favorable Per Patient Microbiological Response at the Test of Cure (TOC) Visit for Patients Infected With Ceftazidime Resistant Pathogens in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.</title>
        <description>The microbiological responses as per the protocoled criteria: responses other than &quot;indeterminate&quot; were classified as &quot;favorable&quot; or &quot;unfavorable.&quot; Favorable microbiological response assessments included &quot;eradication&quot; and &quot;presumed eradication.&quot; Unfavorable microbiological response assessments included &quot;persistence,&quot; &quot;persistence with increasing minimum inhibitory concentration (MIC),&quot; and &quot;presumed persistence.&quot; Indeterminate microbiologic response assessments included cases where the clinical response was changed to indeterminate due to an SRP assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).</description>
        <time_frame>At the test of cure (TOC) (Day 28 to 35)</time_frame>
        <population>The microbiological modified intent-to-treat (mMITT) analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.</population>
        <group_list>
          <group group_id="O1">
            <title>Ceftazidime-Avibactam Plus Metronidazole</title>
            <description>Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion</description>
          </group>
          <group group_id="O2">
            <title>Meropenem</title>
            <description>Meropenem powder for solution for infusion 1000mg</description>
          </group>
        </group_list>
        <measure>
          <title>The Proportion of Patients With a Favorable Per Patient Microbiological Response at the Test of Cure (TOC) Visit for Patients Infected With Ceftazidime Resistant Pathogens in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.</title>
          <description>The microbiological responses as per the protocoled criteria: responses other than &quot;indeterminate&quot; were classified as &quot;favorable&quot; or &quot;unfavorable.&quot; Favorable microbiological response assessments included &quot;eradication&quot; and &quot;presumed eradication.&quot; Unfavorable microbiological response assessments included &quot;persistence,&quot; &quot;persistence with increasing minimum inhibitory concentration (MIC),&quot; and &quot;presumed persistence.&quot; Indeterminate microbiologic response assessments included cases where the clinical response was changed to indeterminate due to an SRP assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).</description>
          <population>The microbiological modified intent-to-treat (mMITT) analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.</population>
          <units>Number of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Favorable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unfavorable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Indeterminate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Proportion of Patients With a Favorable Per Patient Microbiological Response at the Test of Cure (TOC) Visit for Patients Infected With Ceftazidime Resistant Pathogens in the Microbiologically Evaluable (ME) Analysis Set.</title>
        <description>The microbiological responses as per the protocoled criteria: responses other than &quot;indeterminate&quot; were classified as &quot;favorable&quot; or &quot;unfavorable.&quot; Favorable microbiological response assessments included &quot;eradication&quot; and &quot;presumed eradication.&quot; Unfavorable microbiological response assessments included &quot;persistence,&quot; &quot;persistence with increasing minimum inhibitory concentration (MIC),&quot; and &quot;presumed persistence.&quot; Indeterminate microbiologic response assessments included cases where the clinical response was changed to indeterminate due to an SRP assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).</description>
        <time_frame>At the test of cure (TOC) (Day 28 to 35)</time_frame>
        <population>Microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible to both treatment groups.</population>
        <group_list>
          <group group_id="O1">
            <title>Ceftazidime-Avibactam Plus Metronidazole</title>
            <description>Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion</description>
          </group>
          <group group_id="O2">
            <title>Meropenem</title>
            <description>Meropenem powder for solution for infusion 1000mg</description>
          </group>
        </group_list>
        <measure>
          <title>The Proportion of Patients With a Favorable Per Patient Microbiological Response at the Test of Cure (TOC) Visit for Patients Infected With Ceftazidime Resistant Pathogens in the Microbiologically Evaluable (ME) Analysis Set.</title>
          <description>The microbiological responses as per the protocoled criteria: responses other than &quot;indeterminate&quot; were classified as &quot;favorable&quot; or &quot;unfavorable.&quot; Favorable microbiological response assessments included &quot;eradication&quot; and &quot;presumed eradication.&quot; Unfavorable microbiological response assessments included &quot;persistence,&quot; &quot;persistence with increasing minimum inhibitory concentration (MIC),&quot; and &quot;presumed persistence.&quot; Indeterminate microbiologic response assessments included cases where the clinical response was changed to indeterminate due to an SRP assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).</description>
          <population>Microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible to both treatment groups.</population>
          <units>Number of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Favorable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unfavorable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Proportion of Patients With a Favorable Per Patient Microbiological Response at the Test of Cure (TOC) Visit for Patients Infected With Ceftazidime Resistant Pathogens in the Extended Microbiologically Evaluable (ME) Analysis Set.</title>
        <description>The microbiological responses as per the protocoled criteria: responses other than &quot;indeterminate&quot; were classified as &quot;favorable&quot; or &quot;unfavorable.&quot; Favorable microbiological response assessments included &quot;eradication&quot; and &quot;presumed eradication.&quot; Unfavorable microbiological response assessments included &quot;persistence,&quot; &quot;persistence with increasing minimum inhibitory concentration (MIC),&quot; and &quot;presumed persistence.&quot; Indeterminate microbiologic response assessments included cases where the clinical response was changed to indeterminate due to an SRP assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).</description>
        <time_frame>At the test of cure (TOC) (Day 28 to 35)</time_frame>
        <population>Extended microbiologically evaluable(ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture regardless of susceptibility.</population>
        <group_list>
          <group group_id="O1">
            <title>Ceftazidime-Avibactam Plus Metronidazole</title>
            <description>Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion</description>
          </group>
          <group group_id="O2">
            <title>Meropenem</title>
            <description>Meropenem powder for solution for infusion 1000mg</description>
          </group>
        </group_list>
        <measure>
          <title>The Proportion of Patients With a Favorable Per Patient Microbiological Response at the Test of Cure (TOC) Visit for Patients Infected With Ceftazidime Resistant Pathogens in the Extended Microbiologically Evaluable (ME) Analysis Set.</title>
          <description>The microbiological responses as per the protocoled criteria: responses other than &quot;indeterminate&quot; were classified as &quot;favorable&quot; or &quot;unfavorable.&quot; Favorable microbiological response assessments included &quot;eradication&quot; and &quot;presumed eradication.&quot; Unfavorable microbiological response assessments included &quot;persistence,&quot; &quot;persistence with increasing minimum inhibitory concentration (MIC),&quot; and &quot;presumed persistence.&quot; Indeterminate microbiologic response assessments included cases where the clinical response was changed to indeterminate due to an SRP assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).</description>
          <population>Extended microbiologically evaluable(ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture regardless of susceptibility.</population>
          <units>Number of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Favorable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unfavorable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Time to First Defervescence in the Clinically Evaluable (CE) Analysis Set for Patients Who Have Fever at Study Entry.</title>
        <description>Time to first defervescence was calculated for patients with a fever (&gt;38ºC) at baseline. Defervescence (≤37.8ºC) was defined as the absence of fever based on the highest temperature recorded on each study day. Time to first defervescence while on IV study therapy in the CE analysis set at TOC for patients who had fever at study entry is defined as time (in days) from the first dose of IV study therapy to first absence of fever.</description>
        <time_frame>while on study therapy (from Day 1 to Day 14)</time_frame>
        <population>Clinically evaluable (CE) with fever, defined as &gt;38ºC at study entry. No participants were censored at the time of last observation.</population>
        <group_list>
          <group group_id="O1">
            <title>Ceftazidime-Avibactam Plus Metronidazole</title>
            <description>Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion</description>
          </group>
          <group group_id="O2">
            <title>Meropenem</title>
            <description>Meropenem powder for solution for infusion 1000mg</description>
          </group>
        </group_list>
        <measure>
          <title>The Time to First Defervescence in the Clinically Evaluable (CE) Analysis Set for Patients Who Have Fever at Study Entry.</title>
          <description>Time to first defervescence was calculated for patients with a fever (&gt;38ºC) at baseline. Defervescence (≤37.8ºC) was defined as the absence of fever based on the highest temperature recorded on each study day. Time to first defervescence while on IV study therapy in the CE analysis set at TOC for patients who had fever at study entry is defined as time (in days) from the first dose of IV study therapy to first absence of fever.</description>
          <population>Clinically evaluable (CE) with fever, defined as &gt;38ºC at study entry. No participants were censored at the time of last observation.</population>
          <units>Days</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="1" upper_limit="5"/>
                    <measurement group_id="O2" value="1.5" lower_limit="1" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.773</p_value>
            <method>Log Rank</method>
            <param_type>Difference in median time (days)</param_type>
            <param_value>0.5</param_value>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Time to First Defervescence in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set for Patients Who Have Fever at Study Entry.</title>
        <description>Time to first defervescence was calculated for patients with a fever (&gt;38ºC) at baseline. Defervescence (≤37.8ºC) was defined as the absence of fever based on the highest temperature recorded on each study day. Time to first defervescence while on IV study therapy in the CE analysis set at TOC for patients who had fever at study entry is defined as time (in days) from the first dose of IV study therapy to first absence of fever.</description>
        <time_frame>while on study therapy (from Day 1 to Day 14)</time_frame>
        <population>microbiological modified intent-to-treat (mMITT) with fever, defined as &gt;38ºC at study entry. No participants were censored at the time of last observation.</population>
        <group_list>
          <group group_id="O1">
            <title>Ceftazidime-Avibactam Plus Metronidazole</title>
            <description>Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion</description>
          </group>
          <group group_id="O2">
            <title>Meropenem</title>
            <description>Meropenem powder for solution for infusion 1000mg</description>
          </group>
        </group_list>
        <measure>
          <title>The Time to First Defervescence in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set for Patients Who Have Fever at Study Entry.</title>
          <description>Time to first defervescence was calculated for patients with a fever (&gt;38ºC) at baseline. Defervescence (≤37.8ºC) was defined as the absence of fever based on the highest temperature recorded on each study day. Time to first defervescence while on IV study therapy in the CE analysis set at TOC for patients who had fever at study entry is defined as time (in days) from the first dose of IV study therapy to first absence of fever.</description>
          <population>microbiological modified intent-to-treat (mMITT) with fever, defined as &gt;38ºC at study entry. No participants were censored at the time of last observation.</population>
          <units>Days</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="1" upper_limit="5"/>
                    <measurement group_id="O2" value="2" lower_limit="1" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.598</p_value>
            <method>Log Rank</method>
            <param_type>Difference in median time (days)</param_type>
            <param_value>1</param_value>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Safety and Tolerability by Incidence and Severity of Adverse Events and Serious Adverse Events and Mortality.</title>
        <description>Adverse event data were collected from the screening/consent visit until the late follow-up visit (i.e. Day -1/0 to Day 42).</description>
        <time_frame>study duration (from screening to Day 49 LFU visit)</time_frame>
        <population>Safety analysis set: all patients who received at least 1 dose of IP</population>
        <group_list>
          <group group_id="O1">
            <title>Ceftazidime-Avibactam Plus Metronidazole</title>
            <description>Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion</description>
          </group>
          <group group_id="O2">
            <title>Meropenem</title>
            <description>Meropenem powder for solution for infusion 1000mg</description>
          </group>
        </group_list>
        <measure>
          <title>Safety and Tolerability by Incidence and Severity of Adverse Events and Serious Adverse Events and Mortality.</title>
          <description>Adverse event data were collected from the screening/consent visit until the late follow-up visit (i.e. Day -1/0 to Day 42).</description>
          <population>Safety analysis set: all patients who received at least 1 dose of IP</population>
          <units>Number of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="215"/>
                <count group_id="O2" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82"/>
                    <measurement group_id="O2" value="83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any SAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any AE leading to discontinuation of IP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any AE of severe intensity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total number of deaths</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Deaths due to disease progression</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any AE with outcome=death</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Safety and Tolerability by Incidence: Extent of Exposure.</title>
        <description>Duration of exposure is calculated as the difference between the last study therapy date and the first study therapy date converted to days plus 1 day. Actual calculated duration could be shorter or longer than a full day.</description>
        <time_frame>study duration (from screening to Day 49 LFU visit)</time_frame>
        <population>Safety analysis set: all patients who received at least 1 dose of IP</population>
        <group_list>
          <group group_id="O1">
            <title>Ceftazidime-Avibactam Plus Metronidazole</title>
            <description>Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion</description>
          </group>
          <group group_id="O2">
            <title>Meropenem</title>
            <description>Meropenem powder for solution for infusion 1000mg</description>
          </group>
        </group_list>
        <measure>
          <title>Safety and Tolerability by Incidence: Extent of Exposure.</title>
          <description>Duration of exposure is calculated as the difference between the last study therapy date and the first study therapy date converted to days plus 1 day. Actual calculated duration could be shorter or longer than a full day.</description>
          <population>Safety analysis set: all patients who received at least 1 dose of IP</population>
          <units>Number of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="215"/>
                <count group_id="O2" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>1 - 2 days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 - 4 days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 -10 days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="175"/>
                    <measurement group_id="O2" value="181"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>11 - 14 days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;14 days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Safety and Tolerability: Clinical Laboratory Evaluation Hematology.</title>
        <description>Potentially clinically significant (PCS) post Baseline hematology values up to LFU (Safety analysis set)</description>
        <time_frame>study duration (from screening to Day 49 LFU visit)</time_frame>
        <population>Safety analysis set: all patients who received at least 1 dose of IP</population>
        <group_list>
          <group group_id="O1">
            <title>Ceftazidime-Avibactam Plus Metronidazole</title>
            <description>Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion</description>
          </group>
          <group group_id="O2">
            <title>Meropenem</title>
            <description>Meropenem powder for solution for infusion 1000mg</description>
          </group>
        </group_list>
        <measure>
          <title>Safety and Tolerability: Clinical Laboratory Evaluation Hematology.</title>
          <description>Potentially clinically significant (PCS) post Baseline hematology values up to LFU (Safety analysis set)</description>
          <population>Safety analysis set: all patients who received at least 1 dose of IP</population>
          <units>Number of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="215"/>
                <count group_id="O2" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Platelet count: PCS (Low)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelet count: PCS (High)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Red blood cell count: PCS (Low)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Red blood cell count: PCS (High)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White blood cell: PCS (Low)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White blood cell: PCS (High)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoglobin: PCS (Low)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoglobin: PCS (High)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes: PCS (Low)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes: PCS (High)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophils: PCS (Low)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophils: PCS (High)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Eosinophils: PCS (High)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Monocytes: PCS (High)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Basophils: PCS (High)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Direct Coombs test:- at Baseline, + post-Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hematocrit (ratio): PCS (Low)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hematocrit (ratio): PCS (High)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Safety and Tolerability: Clinical Laboratory Evaluation Clinical Chemistry.</title>
        <description>Potentially clinically significant (PCS) post Baseline clinical chemistry values up to LFU (Safety analysis set)</description>
        <time_frame>study duration (from screening to Day 49 LFU visit)</time_frame>
        <population>Safety analysis set: all patients who received at least 1 dose of IP</population>
        <group_list>
          <group group_id="O1">
            <title>Ceftazidime-Avibactam Plus Metronidazole</title>
            <description>Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion</description>
          </group>
          <group group_id="O2">
            <title>Meropenem</title>
            <description>Meropenem powder for solution for infusion 1000mg</description>
          </group>
        </group_list>
        <measure>
          <title>Safety and Tolerability: Clinical Laboratory Evaluation Clinical Chemistry.</title>
          <description>Potentially clinically significant (PCS) post Baseline clinical chemistry values up to LFU (Safety analysis set)</description>
          <population>Safety analysis set: all patients who received at least 1 dose of IP</population>
          <units>Number of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="215"/>
                <count group_id="O2" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Alanine aminotransferase (μkat/L): PCS (High)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alkaline phosphatase (μkat/L): PCS (Low)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alkaline phosphatase (μkat/L): PCS (High)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Aspartate aminotransferase (μkat/L): PCS (High)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bicarbonate (mmol/L) PCS (Low)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bicarbonate (mmol/L): PCS (High)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatinine (μmol/L): PCS (High)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose (non-fasting) (mmol/L): PCS (Low)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose (non-fasting) (mmol/L): PCS (High)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Gamma-glutamyl transferase (μkat/L):PCS (High)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Inorganic phosphorus (mmol/L): PCS (Low)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Inorganic phosphorus (mmol/L): PCS (High)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium (mmol/L): PCS (Low)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium (mmol/L): PCS (High)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total bilirubin (μmol/L): PCS (High)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Direct bilirubin (μmol/L): PCS (High)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Safety and Tolerability:ECG , QTcB and QTcF Intervals</title>
        <description>Shifts in ECG interpretation and changes in QT, QTcB, and QTcF intervals , from baseline to post baseline.</description>
        <time_frame>EOT visit/any observation on treatment</time_frame>
        <population>Safety analysis set: all patients who received at least 1 dose of IP</population>
        <group_list>
          <group group_id="O1">
            <title>Ceftazidime-Avibactam Plus Metronidazole</title>
            <description>Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion</description>
          </group>
          <group group_id="O2">
            <title>Meropenem</title>
            <description>Meropenem powder for solution for infusion 1000mg</description>
          </group>
        </group_list>
        <measure>
          <title>Safety and Tolerability:ECG , QTcB and QTcF Intervals</title>
          <description>Shifts in ECG interpretation and changes in QT, QTcB, and QTcF intervals , from baseline to post baseline.</description>
          <population>Safety analysis set: all patients who received at least 1 dose of IP</population>
          <units>Number of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="215"/>
                <count group_id="O2" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Normal to Abnormal: EOT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Normal to Abnormal: Anytime up to EOT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                    <measurement group_id="O2" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reaching a value in QT: ≥450 (ms)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reaching a value in QT: ≥480 (ms)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reaching a value in QT: ≥500 (ms)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QT: ≥500 and increase from Baseline ≥60(ms)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Increase in QT: ≥30 (ms)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="115"/>
                    <measurement group_id="O2" value="114"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Increase in QT: ≥60 (ms)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50"/>
                    <measurement group_id="O2" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Decrease in QT: ≥30 (ms)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Decrease in QT: ≥60 (ms)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reaching a value in QTcB: ≥450(ms)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57"/>
                    <measurement group_id="O2" value="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reaching a value in QTcB: ≥480(ms)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reaching a value in QTcB: ≥500 (ms)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcB: ≥500 and increase from Baseline ≥60(ms)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Increase in QTcB: ≥30 (ms)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Increase in QTcB: ≥60 (ms)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Decrease in QTcB: ≥30 (ms)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Decrease in QTcB: ≥60 (ms)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reaching a value in QTcF: ≥450 (ms)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reaching a value in QTcF: ≥480 (ms)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reaching a value in QTcF: ≥500 (ms)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcF: ≥500 and increase from Baseline ≥60 (ms)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Increase in QTcF: ≥30 (ms)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42"/>
                    <measurement group_id="O2" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Increase in QTcF: ≥60 (ms)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Decrease QTcF: ≥30 (ms)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Decrease QTcF: ≥60 (ms)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Plasma Concentrations for Ceftazidime and Avibactam</title>
        <description>Blood samples were taken from all patients on Day 3 for the pharmacokinetic evaluation of ceftazidime and avibactam plasma concentrations</description>
        <time_frame>At Day 3: Anytime within 15 minutes prior to or after stopping study drug, anytime between 30 and 90 minutes after stopping study drug, anytime between 300 minutes and 360 minutes after stopping study drug.</time_frame>
        <population>PK analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Ceftazidime(1)</title>
            <description>15 minutes before or after</description>
          </group>
          <group group_id="O2">
            <title>Avibactam(1)</title>
            <description>15 minutes before or after</description>
          </group>
          <group group_id="O3">
            <title>Ceftazidime(2)</title>
            <description>30-90 minutes after</description>
          </group>
          <group group_id="O4">
            <title>Avibactam(2)</title>
            <description>30-90 minutes after</description>
          </group>
          <group group_id="O5">
            <title>Ceftazidime(3)</title>
            <description>300-360 minutes after</description>
          </group>
          <group group_id="O6">
            <title>Avibactam(3)</title>
            <description>300-360 minutes after</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Concentrations for Ceftazidime and Avibactam</title>
          <description>Blood samples were taken from all patients on Day 3 for the pharmacokinetic evaluation of ceftazidime and avibactam plasma concentrations</description>
          <population>PK analysis set</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="195"/>
                <count group_id="O2" value="195"/>
                <count group_id="O3" value="193"/>
                <count group_id="O4" value="193"/>
                <count group_id="O5" value="192"/>
                <count group_id="O6" value="192"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60300.4" lower_limit="1390" upper_limit="1880000"/>
                    <measurement group_id="O2" value="10126.9" lower_limit="197" upper_limit="435000"/>
                    <measurement group_id="O3" value="46473.9" lower_limit="2080" upper_limit="210000"/>
                    <measurement group_id="O4" value="7289.3" lower_limit="229" upper_limit="36300"/>
                    <measurement group_id="O5" value="9555.0" lower_limit="1740" upper_limit="222000"/>
                    <measurement group_id="O6" value="1207.2" lower_limit="227" upper_limit="36300"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data were collected from the screening/consent visit until the late follow-up visit (i.e. Day -1/0 to Day 42). FOR SAE's - only those reported by 2 or more patients in either group are shown in this summary.</time_frame>
      <desc>AEs spontaneously reported by the patient or care provider or reported in response to the open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF.</desc>
      <group_list>
        <group group_id="E1">
          <title>CAZ-AVI Plus Metronidazole</title>
        </group>
        <group group_id="E2">
          <title>Meropenem</title>
          <description>Meropenem powder for solution for infusion 1000mg</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 18.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="215"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="215"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Arteriosclerosis coronary artery</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="215"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain lower</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="215"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Gastric ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="215"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Impaired healing</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholangitis acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="215"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Hepatic function abnormal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="215"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abdominal infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="215"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Postoperative wound infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="215"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Incision site complication</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Metastasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="215"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Non-Hodgkin's lymphoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="215"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute respiratory distress syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="215"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Laryngeal disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="215"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Pneumonia aspiration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2</frequency_threshold>
        <default_vocab>MedDRA 18.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="44" subjects_at_risk="215"/>
                <counts group_id="E2" subjects_affected="47" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="215"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="14" subjects_affected="13" subjects_at_risk="215"/>
                <counts group_id="E2" events="20" subjects_affected="16" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="25" subjects_affected="18" subjects_at_risk="215"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="8" subjects_affected="5" subjects_at_risk="215"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="12" subjects_affected="9" subjects_at_risk="215"/>
                <counts group_id="E2" events="21" subjects_affected="12" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatic function abnormal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="215"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="215"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Productive cough</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="215"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The investigator agrees not to use such Confidential study information and not to disclose them to any other third parties, except that the undersigned shall not be prevented from using or disclosing information: (a) which by written records was previously known; (b) which is now public knowledge, (c) which is lawfully obtained by the undersigned from sources who have a lawful right to disclose such information.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>David Wilson, Statistical Team Leader - Infection</name_or_title>
      <organization>AstraZeneca</organization>
      <phone>+44 1625 517830</phone>
      <email>David.Wilson2@astrazeneca.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01726023
org study id: D4280C00018
secondary id: 2011-003893-97
nct id: NCT01726023
lead sponsor: 
The purpose of this study is to evaluate the effects of Ceftazidime Avibactam plus
      Metronidazole compared to Meropenem for treating hospitalized patients with complicated
      intra-abdominal infections.
A Phase III, Randomized, Multicenter, Double Blind, Double-Dummy, Parallel-Group, Comparative
      Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime Avibactam Plus
      Metronidazole Versus Meropenem in the Treatment of Complicated Intra-Abdominal Infections In
      Hospitalized Adults
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Clinically Evaluable (CE) Analysis Set.
time frame: At the test of cure visit (Day 28 to35)
description: The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.
measure: The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Microbiologically Evaluable (ME) Analysis Set.
time frame: At the end of treatment (EOT) (within 24 hours after last IV dose)
description: The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.
measure: The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Microbiologically Evaluable (ME) Analysis Set.
time frame: At the test of cure (TOC) (Day 28 to 35)
description: The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.
measure: The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Microbiologically Evaluable (ME) Analysis Set.
time frame: At the late follow up (LFU) (Day 42 to 49)
description: The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.
measure: The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.
time frame: At the end of treatment (EOT) (within 24 hours after last IV dose)
description: The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.
measure: The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.
time frame: At the test of cure (TOC) (Day 28 to 35)
description: The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.
measure: The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.
time frame: At the late follow up (LFU) (Day 42 to 49)
description: The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.
measure: The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.
time frame: At the end of treatment (EOT) (within 24 hours after last IV dose)
description: The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.
measure: The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.
time frame: At the test of cure (TOC) (Day 28 to 35)
description: The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.
measure: The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.
time frame: At the late follow up (LFU) (Day 42 to 49)
description: The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.
measure: The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Clinically Evaluable (CE) Analysis Set.
time frame: At the end of treatment (EOT) (within 24 hours after last IV dose)
description: The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.
measure: The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Clinically Evaluable (CE) Analysis Set.
time frame: At late follow up (LFU) visits (Day 42 to 49)
description: The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.
measure: The Proportion of Patients With a Favorable Per-patient Microbiological Response at the End of Treatment (EOT) Visit in the Microbiologically Evaluable (ME) Analysis Set.
time frame: At the end of treatment (EOT) (within 24 hours after last IV dose)
description: Per-patient "favorable" response indicates that all of the patient's baseline pathogens are "eradicated" or "presumed eradicated".
measure: The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Test of Cure (TOC) Visit in the Microbiologically Evaluable (ME) Analysis Set.
time frame: At the test of cure (TOC) (Day 28 to 35)
description: Per-patient "favorable" response indicates that all of the patient's baseline pathogens are "eradicated" or "presumed eradicated".
measure: The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Late Follow up (LFU) Visit in the Microbiologically Evaluable (ME) Analysis Set.
time frame: At the late follow up (LFU) (Day 42 to 49)
description: Per-patient "favorable" response indicates that all of the patient's baseline pathogens are "eradicated" or "presumed eradicated".
measure: The Proportion of Patients With a Favorable Per-patient Microbiological Response at the End of Treatment (EOT) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.
time frame: At the end of treatment (EOT) (within 24 hours after last IV dose)
description: Per-patient "favorable" response indicates that all of the patient's baseline pathogens are "eradicated" or "presumed eradicated".
measure: The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Test of Cure (TOC) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.
time frame: At the test of cure (TOC) (Day 28 to 35)
description: Per-patient "favorable" response indicates that all of the patient's baseline pathogens are "eradicated" or "presumed eradicated".
measure: The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Late Follow up (LFU) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.
time frame: At the late follow up (LFU) (Day 42 to 49)
description: Per-patient "favorable" response indicates that all of the patient's baseline pathogens are "eradicated" or "presumed eradicated".
measure: The Proportion of Patients With a Favorable Per-patient Microbiological Response at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.
time frame: At the end of treatment (EOT) (within 24 hours after last IV dose)
description: Per-patient "favorable" response indicates that all of the patient's baseline pathogens are "eradicated" or "presumed eradicated".
measure: The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.
time frame: At the test of cure (TOC) (Day 28 to 35)
description: Per-patient "favorable" response indicates that all of the patient's baseline pathogens are "eradicated" or "presumed eradicated".
measure: The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.
time frame: At the late follow up (LFU) (Day 42 to 49)
description: Per-patient "favorable" response indicates that all of the patient's baseline pathogens are "eradicated" or "presumed eradicated".
measure: The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.
time frame: At the end of treatment (EOT) (within 24 hours after last IV dose)
description: The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.
measure: The Proportion of Favorable Per-pathogen Microbiological Response in the Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.
time frame: At the test of cure (TOC) (Day 28 to 35)
description: The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.
measure: The Proportion of Favorable Per-pathogen Microbiological Response in the Microbiological Response at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.
time frame: At the late follow up (LFU) (Day 42 to 49)
description: The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.
measure: The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Microbiologically Evaluable (ME) Analysis Set.
time frame: At the end of treatment (EOT) (within 24 hours after last IV dose)
description: The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.
measure: The Proportion of Favorable Per-pathogen Microbiological Response at the Test of Cure (TOC) Visit in the Microbiologically Evaluable (ME) Analysis Set.
time frame: At the test of cure (TOC) (Day 28 to 35)
description: The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.
measure: The Proportion of Favorable Per-pathogen Microbiological Response at the Late Follow up (LFU) Visit in the Microbiologically Evaluable (ME) Analysis Set.
time frame: At the late follow up (LFU) (Day 42 to 49)
description: The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.
measure: The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.
time frame: At the end of treatment (EOT) (within 24 hours after last IV dose)
description: The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.
measure: The Proportion of Favorable Per-pathogen Microbiological Response at the Test of Cure (TOC) Visit in the Extended Microbiologically Evaluable(ME) Analysis Set.
time frame: At the test of cure (TOC) (Day 28 to 35)
description: The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.
measure: The Proportion of Favorable Per-pathogen Microbiological Response at the Late Follow up (LFU) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.
time frame: At the late follow up (LFU) (Day 42 to 49)
description: The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.
measure: The Proportion of Patients With a Favorable Per Patient Microbiological Response at the Test of Cure (TOC) Visit for Patients Infected With Ceftazidime Resistant Pathogens in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.
time frame: At the test of cure (TOC) (Day 28 to 35)
description: The microbiological responses as per the protocoled criteria: responses other than "indeterminate" were classified as "favorable" or "unfavorable." Favorable microbiological response assessments included "eradication" and "presumed eradication." Unfavorable microbiological response assessments included "persistence," "persistence with increasing minimum inhibitory concentration (MIC)," and "presumed persistence." Indeterminate microbiologic response assessments included cases where the clinical response was changed to indeterminate due to an SRP assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).
measure: The Proportion of Patients With a Favorable Per Patient Microbiological Response at the Test of Cure (TOC) Visit for Patients Infected With Ceftazidime Resistant Pathogens in the Microbiologically Evaluable (ME) Analysis Set.
time frame: At the test of cure (TOC) (Day 28 to 35)
description: The microbiological responses as per the protocoled criteria: responses other than "indeterminate" were classified as "favorable" or "unfavorable." Favorable microbiological response assessments included "eradication" and "presumed eradication." Unfavorable microbiological response assessments included "persistence," "persistence with increasing minimum inhibitory concentration (MIC)," and "presumed persistence." Indeterminate microbiologic response assessments included cases where the clinical response was changed to indeterminate due to an SRP assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).
measure: The Proportion of Patients With a Favorable Per Patient Microbiological Response at the Test of Cure (TOC) Visit for Patients Infected With Ceftazidime Resistant Pathogens in the Extended Microbiologically Evaluable (ME) Analysis Set.
time frame: At the test of cure (TOC) (Day 28 to 35)
description: The microbiological responses as per the protocoled criteria: responses other than "indeterminate" were classified as "favorable" or "unfavorable." Favorable microbiological response assessments included "eradication" and "presumed eradication." Unfavorable microbiological response assessments included "persistence," "persistence with increasing minimum inhibitory concentration (MIC)," and "presumed persistence." Indeterminate microbiologic response assessments included cases where the clinical response was changed to indeterminate due to an SRP assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).
measure: The Time to First Defervescence in the Clinically Evaluable (CE) Analysis Set for Patients Who Have Fever at Study Entry.
time frame: while on study therapy (from Day 1 to Day 14)
description: Time to first defervescence was calculated for patients with a fever (>38ºC) at baseline. Defervescence (≤37.8ºC) was defined as the absence of fever based on the highest temperature recorded on each study day. Time to first defervescence while on IV study therapy in the CE analysis set at TOC for patients who had fever at study entry is defined as time (in days) from the first dose of IV study therapy to first absence of fever.
measure: The Time to First Defervescence in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set for Patients Who Have Fever at Study Entry.
time frame: while on study therapy (from Day 1 to Day 14)
description: Time to first defervescence was calculated for patients with a fever (>38ºC) at baseline. Defervescence (≤37.8ºC) was defined as the absence of fever based on the highest temperature recorded on each study day. Time to first defervescence while on IV study therapy in the CE analysis set at TOC for patients who had fever at study entry is defined as time (in days) from the first dose of IV study therapy to first absence of fever.
measure: Safety and Tolerability by Incidence and Severity of Adverse Events and Serious Adverse Events and Mortality.
time frame: study duration (from screening to Day 49 LFU visit)
description: Adverse event data were collected from the screening/consent visit until the late follow-up visit (i.e. Day -1/0 to Day 42).
measure: Safety and Tolerability by Incidence: Extent of Exposure.
time frame: study duration (from screening to Day 49 LFU visit)
description: Duration of exposure is calculated as the difference between the last study therapy date and the first study therapy date converted to days plus 1 day. Actual calculated duration could be shorter or longer than a full day.
measure: Safety and Tolerability: Clinical Laboratory Evaluation Hematology.
time frame: study duration (from screening to Day 49 LFU visit)
description: Potentially clinically significant (PCS) post Baseline hematology values up to LFU (Safety analysis set)
measure: Safety and Tolerability: Clinical Laboratory Evaluation Clinical Chemistry.
time frame: study duration (from screening to Day 49 LFU visit)
description: Potentially clinically significant (PCS) post Baseline clinical chemistry values up to LFU (Safety analysis set)
measure: Safety and Tolerability:ECG , QTcB and QTcF Intervals
time frame: EOT visit/any observation on treatment
description: Shifts in ECG interpretation and changes in QT, QTcB, and QTcF intervals , from baseline to post baseline.
measure: Plasma Concentrations for Ceftazidime and Avibactam
time frame: At Day 3: Anytime within 15 minutes prior to or after stopping study drug, anytime between 30 and 90 minutes after stopping study drug, anytime between 300 minutes and 360 minutes after stopping study drug.
description: Blood samples were taken from all patients on Day 3 for the pharmacokinetic evaluation of ceftazidime and avibactam plasma concentrations
arm group label: Ceftazidime-Avibactam plus metronidazole
arm group type: Experimental
arm group label: Meropenem
arm group type: Active Comparator
intervention type: Drug
intervention name: Ceftazidime-avibactam
description: Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg
arm group label: Ceftazidime-Avibactam plus metronidazole
intervention type: Drug
intervention name: metronidazole
description: Metronidazole 500mg/100ml solution for infusion
arm group label: Ceftazidime-Avibactam plus metronidazole
intervention type: Drug
intervention name: Meropenem
description: Meropenem powder for solution for infusion 1000mg
arm group label: Meropenem
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Paul A Newell, MBBS, MRCP
role: Study Director
affiliation: AstraZeneca
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country: China
country: Korea, Republic of
country: Vietnam
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Intraabdominal Infections
mesh term: Metronidazole
mesh term: Meropenem
mesh term: Ceftazidime
mesh term: Avibactam
mesh term: Avibactam, ceftazidime drug combination
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 