<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <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/NCT03032380</url>
  </required_header>
  <id_info>
    <org_study_id>1615R2132</org_study_id>
    <secondary_id>2016-003020-23</secondary_id>
    <nct_id>NCT03032380</nct_id>
  </id_info>
  <brief_title>Clinical Study of Cefiderocol (S-649266) for the Treatment of Nosocomial Pneumonia Caused by Gram-negative Pathogens</brief_title>
  <acronym>APEKS-NP</acronym>
  <official_title>A Multicenter, Randomized, Double-blind, Parallel-group, Clinical Study of S-649266 Compared With Meropenem for the Treatment of Hospital-acquired Bacterial Pneumonia, Ventilator-associated Bacterial Pneumonia, or Healthcare-associated Bacterial Pneumonia Caused by Gram-negative Pathogens</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shionogi</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shionogi Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to compare all-cause mortality at Day 14 in&#xD;
      participants receiving cefiderocol with participants receiving the comparator, meropenem, in&#xD;
      adults with hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial&#xD;
      pneumonia (VABP), or healthcare-associated bacterial pneumonia (HCABP) caused by&#xD;
      Gram-negative pathogens.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 24, 2017</start_date>
  <completion_date type="Actual">April 1, 2019</completion_date>
  <primary_completion_date type="Actual">February 26, 2019</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>Yes</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>All-cause Mortality Rate at Day 14</measure>
    <time_frame>From first dose of study drug to Day 14</time_frame>
    <description>The all-cause mortality (ACM) rate at Day 14 was calculated as the percentage of participants in each treatment group who experienced mortality, regardless of the cause, from the first infusion of study drug up to Day 14.&#xD;
The Modified Intent-to-Treat Population included all randomized participants who met either of the following criteria:&#xD;
Evidence of Gram-negative infection of the lower respiratory tract based on a culture, Gram-stain, or other diagnostic test&#xD;
Evidence of a lower respiratory tract infection but culture or other diagnostic tests did not provide a microbiologic diagnosis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Microbiologic Eradication at Test of Cure (TOC)</measure>
    <time_frame>Test of cure (7 days after end of treatment; equivalent to Study Day 14 to 21)</time_frame>
    <description>Lower respiratory tract specimens (eg, sputum, endotracheal aspiration [ETA], endobronchial culture specimens collected by bronchoalveolar lavage [BAL], or protected specimen brush [PSB], lung biopsy tissue, pleural effusions, etc) were sent to the local microbiology laboratory for isolation and identification of pathogens.&#xD;
Microbiological outcome by Baseline pathogen at TOC was determined by the sponsor as either Eradication, Persistence, or Indeterminate. Overall per-participant microbiological outcome was determined based on the individual microbiological outcomes for each Baseline pathogen.&#xD;
Eradication: Absence of all Baseline Gram-negative pathogens from an appropriate clinical specimen (sputum, tracheal aspirate, bronchoalveolar lavage (BAL) fluid, protected specimen brush, pleural fluid, or lung biopsy). If it was not possible to obtain an appropriate clinical culture, and the participant had a successful clinical outcome, the response was presumed as eradication.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Clinical Cure at Test of Cure</measure>
    <time_frame>Test of cure (7 days after the end of treatment; equivalent to Study Day 14 to 21)</time_frame>
    <description>Clinical outcome was assessed by the investigator as either Clinical Cure, Clinical Failure, or Indeterminate.&#xD;
Clinical Cure: Resolution or substantial improvement of Baseline signs and symptoms of pneumonia, including a reduction in Sequential Organ Failure Assessment (SOFA) and Clinical Pulmonary Infection Score (CPIS) scores, and improvement or lack of progression of chest radiographic abnormalities such that no additional antibacterial therapy was required for the treatment of the current infection.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Clinical Cure at Early Assessment (EA)</measure>
    <time_frame>Early assessment (Day 3-4 after the start of treatment)</time_frame>
    <description>Clinical outcome was assessed by the investigator as either Clinical Cure, Clinical Failure, or Indeterminate.&#xD;
Clinical Cure: Resolution or substantial improvement of Baseline signs and symptoms of pneumonia, including a reduction in Sequential Organ Failure Assessment (SOFA) and Clinical Pulmonary Infection Score (CPIS) scores, and improvement or lack of progression of chest radiographic abnormalities such that no additional antibacterial therapy was required for the treatment of the current infection.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Clinical Cure at End of Treatment (EOT)</measure>
    <time_frame>End of treatment (Day 7 to 14)</time_frame>
    <description>Clinical outcome was assessed by the investigator as either Clinical Cure, Clinical Failure, or Indeterminate.&#xD;
Clinical Cure: Resolution or substantial improvement of Baseline signs and symptoms of pneumonia, including a reduction in Sequential Organ Failure Assessment (SOFA) and Clinical Pulmonary Infection Score (CPIS) scores, and improvement or lack of progression of chest radiographic abnormalities such that no additional antibacterial therapy was required for the treatment of the current infection.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Sustained Clinical Cure at Follow-up (FU)</measure>
    <time_frame>Follow-up (14 days after the end of treatment; Day 21 to 28)</time_frame>
    <description>Clinical outcome was assessed by the investigator at follow-up as either Sustained Clinical Cure, Relapse, or Indeterminate.&#xD;
Sustained Clinical Cure: Continued resolution or substantial improvement of Baseline signs and symptoms of pneumonia, such that no antibacterial therapy was required for the treatment of pneumonia in a participant assessed as cured at TOC.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Microbiologic Eradication at Early Assessment</measure>
    <time_frame>Early Assessment, Days 3 to 4</time_frame>
    <description>Microbiological outcome by Baseline pathogen at Early Assessment was determined by the sponsor as either Eradication, Persistence, or Indeterminate. Overall per-participant microbiological outcome was determined based on the individual microbiological outcomes for each Baseline pathogen.&#xD;
Eradication: Absence of all Baseline Gram-negative pathogens from an appropriate clinical specimen (sputum, tracheal aspirate, BAL fluid, protected specimen brush, pleural fluid, or lung biopsy). If it was not possible to obtain an appropriate clinical culture, and the participant had a successful clinical outcome, the response was presumed as eradication.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Microbiologic Eradication at End of Treatment</measure>
    <time_frame>End of treatment, Day 7 to 14</time_frame>
    <description>Microbiological outcome by Baseline pathogen at End of Treatment was determined by the sponsor as either: Eradication, Persistence, or Indeterminate. Overall per-participant microbiological outcome was determined based on the individual microbiological outcomes for each Baseline pathogen.&#xD;
Eradication: Absence of all Baseline Gram-negative pathogens from an appropriate clinical specimen (sputum, tracheal aspirate, BAL fluid, protected specimen brush, pleural fluid, or lung biopsy). If it was not possible to obtain an appropriate clinical culture, and the participant had a successful clinical outcome, the response was presumed as eradication.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Sustained Microbiologic Eradication at Follow-up</measure>
    <time_frame>Follow-up (14 days after the end of treatment, Days 21 to 28)</time_frame>
    <description>Microbiological outcome by Baseline pathogen at Follow-up was determined by the sponsor as either Sustained Eradication, Persistence, Recurrence, or Indeterminate. Overall per-participant microbiological outcome was determined based on the individual microbiological outcomes for each Baseline pathogen.&#xD;
Sustained eradication: Absence of all Baseline Gram-negative pathogens from an appropriate clinical specimen (sputum, tracheal aspirate, BAL fluid, protected specimen brush, pleural fluid, or lung biopsy) after TOC. If it was not possible to obtain an appropriate clinical culture and the participant had a successful clinical response after TOC, the response was presumed to be eradication.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-cause Mortality Rate at Day 28</measure>
    <time_frame>From first dose of study drug to Day 28</time_frame>
    <description>The all-cause mortality (ACM) rate at Day 28 was calculated as the percentage of participants who experienced mortality, regardless of the cause, from the first dose of study drug up to Day 28.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-cause Mortality Rate at the End of Study</measure>
    <time_frame>From first dose of study drug through end of study (28 days after end of treatment, up to 42 days)</time_frame>
    <description>The all-cause mortality rate during both the treatment and follow-up period (up to the end of study [EOS] visit) was calculated as the percentage of participants who experienced mortality, regardless of the cause, from the first infusion of study drug up to EOS. If a participant discontinued from the study before EOS and survival information was not available, then the survival status for this endpoint for the participant was considered unknown.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Hospitalization Time</measure>
    <time_frame>From first dose of study drug to test of cure (7 days after end of treatment; equivalent to Study Day 14 to 21) and to follow-up (14 days after the end of treatment; Day 21 to 28)</time_frame>
    <description>The length of hospital stay attributable to the study-qualifying infection.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Treatment-Emergent Adverse Events</measure>
    <time_frame>From first dose of study drug through the end of study, up to 42 days.</time_frame>
    <description>The severity of each adverse event (AE) was graded by the investigator according to the following definitions:&#xD;
Mild: A finding or symptom is minor and does not interfere with usual daily activities.&#xD;
Moderate: The event causes discomfort and interferes with usual daily activity or affects clinical status.&#xD;
Severe: The event causes an interruption of the participant's usual daily activities or has a clinically significant effect.&#xD;
The relationship of each AE to the study treatment was determined by the investigator based on whether the AE could be reasonably explained as having been caused by the study drug (treatment related AE [TRAE]).&#xD;
An SAE is defined as any AE occurring at any dose that resulted in any of the following outcomes:&#xD;
Death&#xD;
Life-threatening condition&#xD;
Hospitalization or prolongation of existing hospitalization for treatment&#xD;
Persistent or significant disability/incapacity&#xD;
Congenital anomaly/birth defect&#xD;
Other medically important condition</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">300</enrollment>
  <condition>Healthcare-associated Pneumonia (HCAP)</condition>
  <condition>Hospital Acquired Pneumonia (HAP)</condition>
  <condition>Ventilator Associated Pneumonia (VAP)</condition>
  <arm_group>
    <arm_group_label>Cefiderocol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive 2 g cefiderocol administered intravenously every 8 hours for 7 to 14 days and 600 mg linezolid administered intravenously every 12 hours for at least 5 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Meropenem</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive 2 g meropenem administered intravenously every 8 hours for 7 to 14 days and 600 mg linezolid administered intravenously every 12 hours for at least 5 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cefiderocol</intervention_name>
    <description>2000 mg intravenously every 8 hours for a period of 7 to14 days (dosage adjustment is necessary based on renal function)</description>
    <arm_group_label>Cefiderocol</arm_group_label>
    <other_name>S-649266</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Meropenem</intervention_name>
    <description>2000 mg intravenously every 8 hours for a period of 7 to 14 days (dosage adjustment is necessary based on renal function)</description>
    <arm_group_label>Meropenem</arm_group_label>
    <other_name>Merrem®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Linezolid</intervention_name>
    <description>600 mg of linezolid administered intravenously over 30 minutes to 2 hours, every 12 hours.</description>
    <arm_group_label>Cefiderocol</arm_group_label>
    <arm_group_label>Meropenem</arm_group_label>
    <other_name>Zyvox®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects 18 years or older at the time of signing informed consent&#xD;
&#xD;
          -  Subjects who have provided written informed consent or their informed consent has been&#xD;
             provided by a legally authorized representative&#xD;
&#xD;
          -  Subjects who meet the clinical diagnosis criteria for hospital-acquired bacterial&#xD;
             pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), or&#xD;
             healthcare-associated bacterial pneumonia (HCABP)&#xD;
&#xD;
          -  All subjects must fulfill at least 1 of the following clinical criteria at screening:&#xD;
&#xD;
               1. New onset or worsening of pulmonary symptoms or signs, such as cough, dyspnea,&#xD;
                  tachypnea (eg, respiratory rate &gt; 25 breaths/minute), expectorated sputum&#xD;
                  production, or requirement for mechanical ventilation&#xD;
&#xD;
               2. Hypoxemia (eg, a partial pressure of oxygen [PaO2] &lt; 60 mm Hg while the subject&#xD;
                  is breathing room air, as determined by arterial blood gas [ABG], or worsening of&#xD;
                  the ratio of the PaO2 to the fraction of inspired oxygen [PaO2/FiO2])&#xD;
&#xD;
               3. Need for acute changes in the ventilator support system to enhance oxygenation,&#xD;
                  as determined by worsening oxygenation (ABG or PaO2/FiO2) or needed changes in&#xD;
                  the amount of positive end-expiratory pressure&#xD;
&#xD;
               4. New onset of or increase in (quantity or characteristics) suctioned respiratory&#xD;
                  secretions, demonstrating evidence of inflammation and absence of contamination&#xD;
&#xD;
          -  All subjects must have at least 1 of the following signs:&#xD;
&#xD;
               1. Documented fever (ie, core body temperature [tympanic, rectal, esophageal] ≥ 38°C&#xD;
                  [100.4°F], oral temperature ≥ 37.5°C, or axillary temperature ≥ 37°C)&#xD;
&#xD;
               2. Hypothermia (ie, core body temperature [tympanic, rectal, esophageal] ≤ 35°C&#xD;
                  [95.0°F], oral temperature ≤ 35.5°C and axillary temperature ≤ 36°C)&#xD;
&#xD;
               3. Leukocytosis with a total peripheral white blood cell (WBC) count ≥ 10,000&#xD;
                  cells/mm³&#xD;
&#xD;
               4. Leukopenia with total peripheral WBC count ≤ 4500 cells/mm³&#xD;
&#xD;
               5. Greater than 15% immature neutrophils (bands) noted on peripheral blood smear&#xD;
&#xD;
          -  All subjects must have a chest radiograph during screening showing the presence of new&#xD;
             or progressive infiltrate(s) suggestive of bacterial pneumonia. A computed tomography&#xD;
             (CT) scan in the same time window showing the same findings could also be acceptable&#xD;
&#xD;
          -  All subjects must have a suspected Gram-negative infection involving the lower&#xD;
             respiratory tract&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who have known or suspected community-acquired bacterial pneumonia (CABP),&#xD;
             atypical pneumonia, viral pneumonia, or chemical pneumonia (including aspiration of&#xD;
             gastric contents, inhalation injury)&#xD;
&#xD;
          -  Other exclusions based on the prescribing information of meropenem or linezolid, prior&#xD;
             antibiotic usage, age, and pregnancy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shionogi Clinical Trials Administrator Clinical Support Help Line</last_name>
    <role>Study Director</role>
    <affiliation>Shionogi</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Shionogi Research Site</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06511</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shionogi Research Site</name>
      <address>
        <city>DeLand</city>
        <state>Florida</state>
        <zip>32720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shionogi Research Site</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
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  </location>
  <location>
    <facility>
      <name>Shionogi Research Site</name>
      <address>
        <city>Council Bluffs</city>
        <state>Iowa</state>
        <zip>51503</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Shionogi Research Site</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Shionogi Research Site</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70808</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Shionogi Research Site</name>
      <address>
        <city>Shreveport</city>
        <state>Louisiana</state>
        <zip>71103</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Shionogi Research Site</name>
      <address>
        <city>Annapolis</city>
        <state>Maryland</state>
        <zip>21404</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Shionogi Research Site</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Shionogi Research Site</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110-0250</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Shionogi Research Site</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Shionogi Research Site</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210-1267</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Shionogi Research Site</name>
      <address>
        <city>Bethlehem</city>
        <state>Pennsylvania</state>
        <zip>18105</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Shionogi Research Site</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19141</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Shionogi Research Site</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84132</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Shionogi Research Site</name>
      <address>
        <city>Brussels</city>
        <zip>1020</zip>
        <country>Belgium</country>
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  <location>
    <facility>
      <name>Shionogi Research Site</name>
      <address>
        <city>Brussels</city>
        <zip>1070</zip>
        <country>Belgium</country>
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  <location>
    <facility>
      <name>Shionogi Research Site</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3H3A7</zip>
        <country>Canada</country>
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  <location>
    <facility>
      <name>Shionogi Research Site</name>
      <address>
        <city>Kingston</city>
        <state>Ontario</state>
        <zip>K7L 2V7</zip>
        <country>Canada</country>
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  <location>
    <facility>
      <name>Shionogi Research Site</name>
      <address>
        <city>Brno</city>
        <zip>65693</zip>
        <country>Czechia</country>
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  </location>
  <location>
    <facility>
      <name>Shionogi Research Site</name>
      <address>
        <city>Hradec Kralove</city>
        <zip>50005</zip>
        <country>Czechia</country>
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  <location>
    <facility>
      <name>Shionogi Research Site</name>
      <address>
        <city>Kolin</city>
        <zip>28000</zip>
        <country>Czechia</country>
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  <location>
    <facility>
      <name>Shionogi Research Site</name>
      <address>
        <city>Kyjov</city>
        <zip>69701</zip>
        <country>Czechia</country>
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    <facility>
      <name>Shionogi Research Site</name>
      <address>
        <city>Ostrava-Poruba</city>
        <zip>708 52</zip>
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      <address>
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  <location>
    <facility>
      <name>Shionogi Research Site</name>
      <address>
        <city>Kohtla-Jarve</city>
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        <country>Estonia</country>
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      <name>Shionogi Research Site</name>
      <address>
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        <zip>80010</zip>
        <country>Estonia</country>
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  <location>
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      <name>Shionogi Research Site</name>
      <address>
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        <zip>13419</zip>
        <country>Estonia</country>
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  <location>
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      <name>Shionogi Research Site</name>
      <address>
        <city>Tartu</city>
        <zip>51014</zip>
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  <location>
    <facility>
      <name>Shionogi Research Site</name>
      <address>
        <city>Angers</city>
        <zip>49933</zip>
        <country>France</country>
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  <location>
    <facility>
      <name>Shionogi Research Site</name>
      <address>
        <city>Argenteuil</city>
        <zip>95100</zip>
        <country>France</country>
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  <location>
    <facility>
      <name>Shionogi Research Site</name>
      <address>
        <city>Bron</city>
        <zip>69677</zip>
        <country>France</country>
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  <location>
    <facility>
      <name>Shionogi Research Site</name>
      <address>
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  <keyword>S-649266</keyword>
  <keyword>linezolid</keyword>
  <keyword>meropenem</keyword>
  <keyword>Healthcare-associated pneumonia (HCAP)</keyword>
  <keyword>nosocomial pneumonia</keyword>
  <keyword>Ventilator-associated pneumonia (VAP)</keyword>
  <keyword>Gram-negative pathogens</keyword>
  <keyword>pneumonia</keyword>
  <keyword>cefiderocol</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumonia</mesh_term>
    <mesh_term>Pneumonia, Ventilator-Associated</mesh_term>
    <mesh_term>Healthcare-Associated Pneumonia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Meropenem</mesh_term>
    <mesh_term>Linezolid</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 9, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/80/NCT03032380/SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 22, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/80/NCT03032380/Prot_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study population included participants with hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), or healthcare-associated bacterial pneumonia (HCABP) caused by Gram-negative bacteria.</recruitment_details>
      <pre_assignment_details>Participants were randomized in a 1:1 ratio to either cefiderocol or meropenem. Randomization was performed by the stratified randomization method using infection diagnosis (HABP, VABP, and HCABP) and Acute Physiology and Chronic Health Evaluation II (APACHE II) score (≤ 15 and ≥ 16) as allocation factors.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Cefiderocol</title>
          <description>Participants received 2 g cefiderocol administered intravenously every 8 hours for 7 to 14 days and 600 mg linezolid administered intravenously every 12 hours for at least 5 days.</description>
        </group>
        <group group_id="P2">
          <title>Meropenem</title>
          <description>Participants received 2 g meropenem administered intravenously every 8 hours for 7 to 14 days and 600 mg linezolid administered intravenously every 12 hours for at least 5 days.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="148"/>
                <participants group_id="P2" count="152"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received Treatment</title>
              <participants_list>
                <participants group_id="P1" count="148"/>
                <participants group_id="P2" count="150"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="106"/>
                <participants group_id="P2" count="112"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
                <participants group_id="P2" count="40"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Recovery</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
                <participants group_id="P2" count="34"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other - Miscellaneous</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The intent-to-treat (ITT) population included all randomized participants who received at least 1 dose of study treatment.</population>
      <group_list>
        <group group_id="B1">
          <title>Cefiderocol</title>
          <description>Participants received 2 g cefiderocol administered intravenously every 8 hours for 7 to 14 days and 600 mg linezolid administered intravenously every 12 hours for at least 5 days.</description>
        </group>
        <group group_id="B2">
          <title>Meropenem</title>
          <description>Participants received 2 g meropenem administered intravenously every 8 hours for 7 to 14 days and 600 mg linezolid administered intravenously every 12 hours for at least 5 days.</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="148"/>
            <count group_id="B2" value="150"/>
            <count group_id="B3" value="298"/>
          </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="64.7" spread="14.5"/>
                    <measurement group_id="B2" value="65.6" spread="15.1"/>
                    <measurement group_id="B3" value="65.2" spread="14.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt; 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="65"/>
                    <measurement group_id="B2" value="58"/>
                    <measurement group_id="B3" value="123"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;= 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="83"/>
                    <measurement group_id="B2" value="92"/>
                    <measurement group_id="B3" value="175"/>
                  </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="47"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="93"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="101"/>
                    <measurement group_id="B2" value="104"/>
                    <measurement group_id="B3" value="205"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="140"/>
                    <measurement group_id="B2" value="139"/>
                    <measurement group_id="B3" value="279"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="102"/>
                    <measurement group_id="B2" value="100"/>
                    <measurement group_id="B3" value="202"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="44"/>
                    <measurement group_id="B3" value="88"/>
                  </measurement_list>
                </category>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>North America</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>South America</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Europe</title>
                  <measurement_list>
                    <measurement group_id="B1" value="99"/>
                    <measurement group_id="B2" value="100"/>
                    <measurement group_id="B3" value="199"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asia-Pacific</title>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                    <measurement group_id="B2" value="44"/>
                    <measurement group_id="B3" value="87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Clinical Diagnosis</title>
          <description>HABP = hospital acquired bacterial pneumonia; HCABP = healthcare-associated bacterial pneumonia; VABP = ventilator-associated bacterial pneumonia</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>VABP</title>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                    <measurement group_id="B2" value="65"/>
                    <measurement group_id="B3" value="125"/>
                  </measurement_list>
                </category>
                <category>
                  <title>HABP</title>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                    <measurement group_id="B2" value="61"/>
                    <measurement group_id="B3" value="121"/>
                  </measurement_list>
                </category>
                <category>
                  <title>HCABP</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Acute Physiology and Chronic Health Evaluation II (APACHE II) Score</title>
          <description>Acute Physiology And Chronic Health Evaluation II is a severity-of-disease classification applied within 24 hours of admission of a patient to an intensive care unit (ICU). The APACHE II score consists of three parts: 12 acute physiological variables, age, and chronic health status. The range of the score is 0 to 71, where higher scores correspond to more severe disease and a higher risk of death.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;= 15</title>
                  <measurement_list>
                    <measurement group_id="B1" value="75"/>
                    <measurement group_id="B2" value="78"/>
                    <measurement group_id="B3" value="153"/>
                  </measurement_list>
                </category>
                <category>
                  <title>16 - 19</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="58"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;= 20</title>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>All-cause Mortality Rate at Day 14</title>
        <description>The all-cause mortality (ACM) rate at Day 14 was calculated as the percentage of participants in each treatment group who experienced mortality, regardless of the cause, from the first infusion of study drug up to Day 14.&#xD;
The Modified Intent-to-Treat Population included all randomized participants who met either of the following criteria:&#xD;
Evidence of Gram-negative infection of the lower respiratory tract based on a culture, Gram-stain, or other diagnostic test&#xD;
Evidence of a lower respiratory tract infection but culture or other diagnostic tests did not provide a microbiologic diagnosis</description>
        <time_frame>From first dose of study drug to Day 14</time_frame>
        <population>Modified Intent-to-Treat Population; participants with known survival status.</population>
        <group_list>
          <group group_id="O1">
            <title>Cefiderocol</title>
            <description>Participants received 2 g cefiderocol administered intravenously every 8 hours for 7 to 14 days and 600 mg linezolid administered intravenously every 12 hours for at least 5 days.</description>
          </group>
          <group group_id="O2">
            <title>Meropenem</title>
            <description>Participants received 2 g meropenem administered intravenously every 8 hours for 7 to 14 days and 600 mg linezolid administered intravenously every 12 hours for at least 5 days.</description>
          </group>
        </group_list>
        <measure>
          <title>All-cause Mortality Rate at Day 14</title>
          <description>The all-cause mortality (ACM) rate at Day 14 was calculated as the percentage of participants in each treatment group who experienced mortality, regardless of the cause, from the first infusion of study drug up to Day 14.&#xD;
The Modified Intent-to-Treat Population included all randomized participants who met either of the following criteria:&#xD;
Evidence of Gram-negative infection of the lower respiratory tract based on a culture, Gram-stain, or other diagnostic test&#xD;
Evidence of a lower respiratory tract infection but culture or other diagnostic tests did not provide a microbiologic diagnosis</description>
          <population>Modified Intent-to-Treat Population; participants with known survival status.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="145"/>
                <count group_id="O2" value="146"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.4"/>
                    <measurement group_id="O2" value="11.6"/>
                  </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>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The study hypothesis was that the all-cause mortality rate at Day 14 in participants who received cefiderocol would be non-inferior to that in participants who received high-dose meropenem. The margin of non-inferiority was 12.5%. Non-inferiority was concluded if the upper bound of the 2-sided 95% confidence interval for the difference in mortality at Day 14 between the 2 treatment groups (cefiderocol - meropenem) was smaller than 12.5%.</non_inferiority_desc>
            <p_value>0.0020</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Treatment Difference</param_type>
            <param_value>0.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.6</ci_lower_limit>
            <ci_upper_limit>8.2</ci_upper_limit>
            <estimate_desc>Treatment difference (cefiderocol - meropenem) was the adjusted estimate of the difference in the ACM rate at Day 14 based on Cochran-Mantel Haenszel weights using APACHE II score (≤ 15 and ≥ 16) as the stratification factor.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Microbiologic Eradication at Test of Cure (TOC)</title>
        <description>Lower respiratory tract specimens (eg, sputum, endotracheal aspiration [ETA], endobronchial culture specimens collected by bronchoalveolar lavage [BAL], or protected specimen brush [PSB], lung biopsy tissue, pleural effusions, etc) were sent to the local microbiology laboratory for isolation and identification of pathogens.&#xD;
Microbiological outcome by Baseline pathogen at TOC was determined by the sponsor as either Eradication, Persistence, or Indeterminate. Overall per-participant microbiological outcome was determined based on the individual microbiological outcomes for each Baseline pathogen.&#xD;
Eradication: Absence of all Baseline Gram-negative pathogens from an appropriate clinical specimen (sputum, tracheal aspirate, bronchoalveolar lavage (BAL) fluid, protected specimen brush, pleural fluid, or lung biopsy). If it was not possible to obtain an appropriate clinical culture, and the participant had a successful clinical outcome, the response was presumed as eradication.</description>
        <time_frame>Test of cure (7 days after end of treatment; equivalent to Study Day 14 to 21)</time_frame>
        <population>Modified Intent-to-Treat Population; participants with non-missing Baseline pathogen data</population>
        <group_list>
          <group group_id="O1">
            <title>Cefiderocol</title>
            <description>Participants received 2 g cefiderocol administered intravenously every 8 hours for 7 to 14 days and 600 mg linezolid administered intravenously every 12 hours for at least 5 days.</description>
          </group>
          <group group_id="O2">
            <title>Meropenem</title>
            <description>Participants received 2 g meropenem administered intravenously every 8 hours for 7 to 14 days and 600 mg linezolid administered intravenously every 12 hours for at least 5 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Microbiologic Eradication at Test of Cure (TOC)</title>
          <description>Lower respiratory tract specimens (eg, sputum, endotracheal aspiration [ETA], endobronchial culture specimens collected by bronchoalveolar lavage [BAL], or protected specimen brush [PSB], lung biopsy tissue, pleural effusions, etc) were sent to the local microbiology laboratory for isolation and identification of pathogens.&#xD;
Microbiological outcome by Baseline pathogen at TOC was determined by the sponsor as either Eradication, Persistence, or Indeterminate. Overall per-participant microbiological outcome was determined based on the individual microbiological outcomes for each Baseline pathogen.&#xD;
Eradication: Absence of all Baseline Gram-negative pathogens from an appropriate clinical specimen (sputum, tracheal aspirate, bronchoalveolar lavage (BAL) fluid, protected specimen brush, pleural fluid, or lung biopsy). If it was not possible to obtain an appropriate clinical culture, and the participant had a successful clinical outcome, the response was presumed as eradication.</description>
          <population>Modified Intent-to-Treat Population; participants with non-missing Baseline pathogen data</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
                <count group_id="O2" value="127"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.6"/>
                    <measurement group_id="O2" value="48.0"/>
                  </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</non_inferiority_type>
            <param_type>Treatment Difference</param_type>
            <param_value>-1.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-13.5</ci_lower_limit>
            <ci_upper_limit>10.7</ci_upper_limit>
            <estimate_desc>Treatment difference (cefiderocol - meropenem) was the adjusted estimate of the difference in the eradication rate calculated using Cochran-Mantel-Haenszel weights based on infection diagnosis (HABP/VABP/HCABP), and APACHE II score (≤ 15 and ≥ 16).</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Clinical Cure at Test of Cure</title>
        <description>Clinical outcome was assessed by the investigator as either Clinical Cure, Clinical Failure, or Indeterminate.&#xD;
Clinical Cure: Resolution or substantial improvement of Baseline signs and symptoms of pneumonia, including a reduction in Sequential Organ Failure Assessment (SOFA) and Clinical Pulmonary Infection Score (CPIS) scores, and improvement or lack of progression of chest radiographic abnormalities such that no additional antibacterial therapy was required for the treatment of the current infection.</description>
        <time_frame>Test of cure (7 days after the end of treatment; equivalent to Study Day 14 to 21)</time_frame>
        <population>Modified Intent-to-Treat Population</population>
        <group_list>
          <group group_id="O1">
            <title>Cefiderocol</title>
            <description>Participants received 2 g cefiderocol administered intravenously every 8 hours for 7 to 14 days and 600 mg linezolid administered intravenously every 12 hours for at least 5 days.</description>
          </group>
          <group group_id="O2">
            <title>Meropenem</title>
            <description>Participants received 2 g meropenem administered intravenously every 8 hours for 7 to 14 days and 600 mg linezolid administered intravenously every 12 hours for at least 5 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Clinical Cure at Test of Cure</title>
          <description>Clinical outcome was assessed by the investigator as either Clinical Cure, Clinical Failure, or Indeterminate.&#xD;
Clinical Cure: Resolution or substantial improvement of Baseline signs and symptoms of pneumonia, including a reduction in Sequential Organ Failure Assessment (SOFA) and Clinical Pulmonary Infection Score (CPIS) scores, and improvement or lack of progression of chest radiographic abnormalities such that no additional antibacterial therapy was required for the treatment of the current infection.</description>
          <population>Modified Intent-to-Treat Population</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="145"/>
                <count group_id="O2" value="147"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64.8"/>
                    <measurement group_id="O2" value="66.7"/>
                  </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</non_inferiority_type>
            <param_type>Treatment Difference</param_type>
            <param_value>-2.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-12.5</ci_lower_limit>
            <ci_upper_limit>8.5</ci_upper_limit>
            <estimate_desc>Treatment difference (cefiderocol - meropenem) was the adjusted estimate of the difference in the cure rate calculated using Cochran-Mantel-Haenszel weights based on infection diagnosis (HABP/VABP/HCABP), and APACHE II score (≤ 15 and ≥ 16).</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Clinical Cure at Early Assessment (EA)</title>
        <description>Clinical outcome was assessed by the investigator as either Clinical Cure, Clinical Failure, or Indeterminate.&#xD;
Clinical Cure: Resolution or substantial improvement of Baseline signs and symptoms of pneumonia, including a reduction in Sequential Organ Failure Assessment (SOFA) and Clinical Pulmonary Infection Score (CPIS) scores, and improvement or lack of progression of chest radiographic abnormalities such that no additional antibacterial therapy was required for the treatment of the current infection.</description>
        <time_frame>Early assessment (Day 3-4 after the start of treatment)</time_frame>
        <population>Modified Intent-to-Treat Population</population>
        <group_list>
          <group group_id="O1">
            <title>Cefiderocol</title>
            <description>Participants received 2 g cefiderocol administered intravenously every 8 hours for 7 to 14 days and 600 mg linezolid administered intravenously every 12 hours for at least 5 days.</description>
          </group>
          <group group_id="O2">
            <title>Meropenem</title>
            <description>Participants received 2 g meropenem administered intravenously every 8 hours for 7 to 14 days and 600 mg linezolid administered intravenously every 12 hours for at least 5 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Clinical Cure at Early Assessment (EA)</title>
          <description>Clinical outcome was assessed by the investigator as either Clinical Cure, Clinical Failure, or Indeterminate.&#xD;
Clinical Cure: Resolution or substantial improvement of Baseline signs and symptoms of pneumonia, including a reduction in Sequential Organ Failure Assessment (SOFA) and Clinical Pulmonary Infection Score (CPIS) scores, and improvement or lack of progression of chest radiographic abnormalities such that no additional antibacterial therapy was required for the treatment of the current infection.</description>
          <population>Modified Intent-to-Treat Population</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="145"/>
                <count group_id="O2" value="147"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.8"/>
                    <measurement group_id="O2" value="83.0"/>
                  </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>Other</non_inferiority_type>
            <param_type>Treatment Difference</param_type>
            <param_value>-0.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.8</ci_lower_limit>
            <ci_upper_limit>8.2</ci_upper_limit>
            <estimate_desc>Treatment difference (cefiderocol - meropenem) was the adjusted estimate of the difference in the cure rate calculated using Cochran-Mantel-Haenszel weights based on infection diagnosis (HABP/VABP/HCABP), and APACHE II score (≤ 15 and ≥ 16).</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Clinical Cure at End of Treatment (EOT)</title>
        <description>Clinical outcome was assessed by the investigator as either Clinical Cure, Clinical Failure, or Indeterminate.&#xD;
Clinical Cure: Resolution or substantial improvement of Baseline signs and symptoms of pneumonia, including a reduction in Sequential Organ Failure Assessment (SOFA) and Clinical Pulmonary Infection Score (CPIS) scores, and improvement or lack of progression of chest radiographic abnormalities such that no additional antibacterial therapy was required for the treatment of the current infection.</description>
        <time_frame>End of treatment (Day 7 to 14)</time_frame>
        <population>Modified Intent-to-Treat Population</population>
        <group_list>
          <group group_id="O1">
            <title>Cefiderocol</title>
            <description>Participants received 2 g cefiderocol administered intravenously every 8 hours for 7 to 14 days and 600 mg linezolid administered intravenously every 12 hours for at least 5 days.</description>
          </group>
          <group group_id="O2">
            <title>Meropenem</title>
            <description>Participants received 2 g meropenem administered intravenously every 8 hours for 7 to 14 days and 600 mg linezolid administered intravenously every 12 hours for at least 5 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Clinical Cure at End of Treatment (EOT)</title>
          <description>Clinical outcome was assessed by the investigator as either Clinical Cure, Clinical Failure, or Indeterminate.&#xD;
Clinical Cure: Resolution or substantial improvement of Baseline signs and symptoms of pneumonia, including a reduction in Sequential Organ Failure Assessment (SOFA) and Clinical Pulmonary Infection Score (CPIS) scores, and improvement or lack of progression of chest radiographic abnormalities such that no additional antibacterial therapy was required for the treatment of the current infection.</description>
          <population>Modified Intent-to-Treat Population</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="145"/>
                <count group_id="O2" value="147"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.2"/>
                    <measurement group_id="O2" value="81.0"/>
                  </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>Other</non_inferiority_type>
            <param_type>Treatment Difference</param_type>
            <param_value>-3.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-12.8</ci_lower_limit>
            <ci_upper_limit>5.1</ci_upper_limit>
            <estimate_desc>Treatment difference (cefiderocol - meropenem) was the adjusted estimate of the difference in the cure rate calculated using Cochran-Mantel-Haenszel weights based on infection diagnosis (HABP/VABP/HCABP), and APACHE II score (≤ 15 and ≥ 16).</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Sustained Clinical Cure at Follow-up (FU)</title>
        <description>Clinical outcome was assessed by the investigator at follow-up as either Sustained Clinical Cure, Relapse, or Indeterminate.&#xD;
Sustained Clinical Cure: Continued resolution or substantial improvement of Baseline signs and symptoms of pneumonia, such that no antibacterial therapy was required for the treatment of pneumonia in a participant assessed as cured at TOC.</description>
        <time_frame>Follow-up (14 days after the end of treatment; Day 21 to 28)</time_frame>
        <population>Modified Intent-to-Treat Population</population>
        <group_list>
          <group group_id="O1">
            <title>Cefiderocol</title>
            <description>Participants received 2 g cefiderocol administered intravenously every 8 hours for 7 to 14 days and 600 mg linezolid administered intravenously every 12 hours for at least 5 days.</description>
          </group>
          <group group_id="O2">
            <title>Meropenem</title>
            <description>Participants received 2 g meropenem administered intravenously every 8 hours for 7 to 14 days and 600 mg linezolid administered intravenously every 12 hours for at least 5 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Sustained Clinical Cure at Follow-up (FU)</title>
          <description>Clinical outcome was assessed by the investigator at follow-up as either Sustained Clinical Cure, Relapse, or Indeterminate.&#xD;
Sustained Clinical Cure: Continued resolution or substantial improvement of Baseline signs and symptoms of pneumonia, such that no antibacterial therapy was required for the treatment of pneumonia in a participant assessed as cured at TOC.</description>
          <population>Modified Intent-to-Treat Population</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="145"/>
                <count group_id="O2" value="147"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.9"/>
                    <measurement group_id="O2" value="57.8"/>
                  </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>Other</non_inferiority_type>
            <param_type>Treatment Difference</param_type>
            <param_value>-0.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-10.9</ci_lower_limit>
            <ci_upper_limit>10.8</ci_upper_limit>
            <estimate_desc>Treatment difference (cefiderocol - meropenem) was the adjusted estimate of the difference in the cure rate calculated using Cochran-Mantel-Haenszel weights based on infection diagnosis (HABP/VABP/HCABP), and APACHE II score (≤ 15 and ≥ 16).</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Microbiologic Eradication at Early Assessment</title>
        <description>Microbiological outcome by Baseline pathogen at Early Assessment was determined by the sponsor as either Eradication, Persistence, or Indeterminate. Overall per-participant microbiological outcome was determined based on the individual microbiological outcomes for each Baseline pathogen.&#xD;
Eradication: Absence of all Baseline Gram-negative pathogens from an appropriate clinical specimen (sputum, tracheal aspirate, BAL fluid, protected specimen brush, pleural fluid, or lung biopsy). If it was not possible to obtain an appropriate clinical culture, and the participant had a successful clinical outcome, the response was presumed as eradication.</description>
        <time_frame>Early Assessment, Days 3 to 4</time_frame>
        <population>Modified Intent-to-Treat Population; participants with non-missing Baseline pathogens</population>
        <group_list>
          <group group_id="O1">
            <title>Cefiderocol</title>
            <description>Participants received 2 g cefiderocol administered intravenously every 8 hours for 7 to 14 days and 600 mg linezolid administered intravenously every 12 hours for at least 5 days.</description>
          </group>
          <group group_id="O2">
            <title>Meropenem</title>
            <description>Participants received 2 g meropenem administered intravenously every 8 hours for 7 to 14 days and 600 mg linezolid administered intravenously every 12 hours for at least 5 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Microbiologic Eradication at Early Assessment</title>
          <description>Microbiological outcome by Baseline pathogen at Early Assessment was determined by the sponsor as either Eradication, Persistence, or Indeterminate. Overall per-participant microbiological outcome was determined based on the individual microbiological outcomes for each Baseline pathogen.&#xD;
Eradication: Absence of all Baseline Gram-negative pathogens from an appropriate clinical specimen (sputum, tracheal aspirate, BAL fluid, protected specimen brush, pleural fluid, or lung biopsy). If it was not possible to obtain an appropriate clinical culture, and the participant had a successful clinical outcome, the response was presumed as eradication.</description>
          <population>Modified Intent-to-Treat Population; participants with non-missing Baseline pathogens</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
                <count group_id="O2" value="127"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.9"/>
                    <measurement group_id="O2" value="53.5"/>
                  </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>Other</non_inferiority_type>
            <param_type>Treatment Difference</param_type>
            <param_value>-12.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-24.4</ci_lower_limit>
            <ci_upper_limit>-0.5</ci_upper_limit>
            <estimate_desc>Treatment difference (cefiderocol - meropenem) was the adjusted estimate of the difference in the cure rate calculated using Cochran-Mantel-Haenszel weights based on infection diagnosis (HABP/VABP/HCABP), and APACHE II score (≤ 15 and ≥ 16).</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Microbiologic Eradication at End of Treatment</title>
        <description>Microbiological outcome by Baseline pathogen at End of Treatment was determined by the sponsor as either: Eradication, Persistence, or Indeterminate. Overall per-participant microbiological outcome was determined based on the individual microbiological outcomes for each Baseline pathogen.&#xD;
Eradication: Absence of all Baseline Gram-negative pathogens from an appropriate clinical specimen (sputum, tracheal aspirate, BAL fluid, protected specimen brush, pleural fluid, or lung biopsy). If it was not possible to obtain an appropriate clinical culture, and the participant had a successful clinical outcome, the response was presumed as eradication.</description>
        <time_frame>End of treatment, Day 7 to 14</time_frame>
        <population>Modified Intent to-Treat Population; participants with non-missing Baseline pathogens</population>
        <group_list>
          <group group_id="O1">
            <title>Cefiderocol</title>
            <description>Participants received 2 g cefiderocol administered intravenously every 8 hours for 7 to 14 days and 600 mg linezolid administered intravenously every 12 hours for at least 5 days.</description>
          </group>
          <group group_id="O2">
            <title>Meropenem</title>
            <description>Participants received 2 g meropenem administered intravenously every 8 hours for 7 to 14 days and 600 mg linezolid administered intravenously every 12 hours for at least 5 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Microbiologic Eradication at End of Treatment</title>
          <description>Microbiological outcome by Baseline pathogen at End of Treatment was determined by the sponsor as either: Eradication, Persistence, or Indeterminate. Overall per-participant microbiological outcome was determined based on the individual microbiological outcomes for each Baseline pathogen.&#xD;
Eradication: Absence of all Baseline Gram-negative pathogens from an appropriate clinical specimen (sputum, tracheal aspirate, BAL fluid, protected specimen brush, pleural fluid, or lung biopsy). If it was not possible to obtain an appropriate clinical culture, and the participant had a successful clinical outcome, the response was presumed as eradication.</description>
          <population>Modified Intent to-Treat Population; participants with non-missing Baseline pathogens</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
                <count group_id="O2" value="127"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.7"/>
                    <measurement group_id="O2" value="66.9"/>
                  </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>Other</non_inferiority_type>
            <param_type>Treatment Difference</param_type>
            <param_value>-3.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-15.5</ci_lower_limit>
            <ci_upper_limit>7.9</ci_upper_limit>
            <estimate_desc>Treatment difference (cefiderocol - meropenem) was the adjusted estimate of the difference in the cure rate calculated using Cochran-Mantel-Haenszel weights based on infection diagnosis (HABP/VABP/HCABP), and APACHE II score (≤ 15 and ≥ 16).</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Sustained Microbiologic Eradication at Follow-up</title>
        <description>Microbiological outcome by Baseline pathogen at Follow-up was determined by the sponsor as either Sustained Eradication, Persistence, Recurrence, or Indeterminate. Overall per-participant microbiological outcome was determined based on the individual microbiological outcomes for each Baseline pathogen.&#xD;
Sustained eradication: Absence of all Baseline Gram-negative pathogens from an appropriate clinical specimen (sputum, tracheal aspirate, BAL fluid, protected specimen brush, pleural fluid, or lung biopsy) after TOC. If it was not possible to obtain an appropriate clinical culture and the participant had a successful clinical response after TOC, the response was presumed to be eradication.</description>
        <time_frame>Follow-up (14 days after the end of treatment, Days 21 to 28)</time_frame>
        <population>Modified Intent-to-Treat Population; participants with non-missing Baseline pathogens</population>
        <group_list>
          <group group_id="O1">
            <title>Cefiderocol</title>
            <description>Participants received 2 g cefiderocol administered intravenously every 8 hours for 7 to 14 days and 600 mg linezolid administered intravenously every 12 hours for at least 5 days.</description>
          </group>
          <group group_id="O2">
            <title>Meropenem</title>
            <description>Participants received 2 g meropenem administered intravenously every 8 hours for 7 to 14 days and 600 mg linezolid administered intravenously every 12 hours for at least 5 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Sustained Microbiologic Eradication at Follow-up</title>
          <description>Microbiological outcome by Baseline pathogen at Follow-up was determined by the sponsor as either Sustained Eradication, Persistence, Recurrence, or Indeterminate. Overall per-participant microbiological outcome was determined based on the individual microbiological outcomes for each Baseline pathogen.&#xD;
Sustained eradication: Absence of all Baseline Gram-negative pathogens from an appropriate clinical specimen (sputum, tracheal aspirate, BAL fluid, protected specimen brush, pleural fluid, or lung biopsy) after TOC. If it was not possible to obtain an appropriate clinical culture and the participant had a successful clinical response after TOC, the response was presumed to be eradication.</description>
          <population>Modified Intent-to-Treat Population; participants with non-missing Baseline pathogens</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
                <count group_id="O2" value="127"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.5"/>
                    <measurement group_id="O2" value="38.6"/>
                  </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>Other</non_inferiority_type>
            <param_type>Treatment Difference</param_type>
            <param_value>3.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.9</ci_lower_limit>
            <ci_upper_limit>15.8</ci_upper_limit>
            <estimate_desc>Treatment difference (cefiderocol - meropenem) was the adjusted estimate of the difference in the cure rate calculated using Cochran-Mantel-Haenszel weights based on infection diagnosis (HABP/VABP/HCABP), and APACHE II score (≤ 15 and ≥ 16).</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>All-cause Mortality Rate at Day 28</title>
        <description>The all-cause mortality (ACM) rate at Day 28 was calculated as the percentage of participants who experienced mortality, regardless of the cause, from the first dose of study drug up to Day 28.</description>
        <time_frame>From first dose of study drug to Day 28</time_frame>
        <population>Modified Intent-to-Treat Population; participants with known survival status.</population>
        <group_list>
          <group group_id="O1">
            <title>Cefiderocol</title>
            <description>Participants received 2 g cefiderocol administered intravenously every 8 hours for 7 to 14 days and 600 mg linezolid administered intravenously every 12 hours for at least 5 days.</description>
          </group>
          <group group_id="O2">
            <title>Meropenem</title>
            <description>Participants received 2 g meropenem administered intravenously every 8 hours for 7 to 14 days and 600 mg linezolid administered intravenously every 12 hours for at least 5 days.</description>
          </group>
        </group_list>
        <measure>
          <title>All-cause Mortality Rate at Day 28</title>
          <description>The all-cause mortality (ACM) rate at Day 28 was calculated as the percentage of participants who experienced mortality, regardless of the cause, from the first dose of study drug up to Day 28.</description>
          <population>Modified Intent-to-Treat Population; participants with known survival status.</population>
          <units>percentage of participants</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="146"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.0"/>
                    <measurement group_id="O2" value="20.5"/>
                  </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>Other</non_inferiority_type>
            <param_type>Treatment Difference</param_type>
            <param_value>0.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.7</ci_lower_limit>
            <ci_upper_limit>9.8</ci_upper_limit>
            <estimate_desc>Treatment difference (cefiderocol - meropenem) was the adjusted estimate of the difference in the ACM rate at Day 28 based on Cochran-Mantel Haenszel weights using APACHE II score (≤ 15 and ≥ 16) as the stratification factor.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>All-cause Mortality Rate at the End of Study</title>
        <description>The all-cause mortality rate during both the treatment and follow-up period (up to the end of study [EOS] visit) was calculated as the percentage of participants who experienced mortality, regardless of the cause, from the first infusion of study drug up to EOS. If a participant discontinued from the study before EOS and survival information was not available, then the survival status for this endpoint for the participant was considered unknown.</description>
        <time_frame>From first dose of study drug through end of study (28 days after end of treatment, up to 42 days)</time_frame>
        <population>Modified Intent-to-Treat Population; participants with known survival status.</population>
        <group_list>
          <group group_id="O1">
            <title>Cefiderocol</title>
            <description>Participants received 2 g cefiderocol administered intravenously every 8 hours for 7 to 14 days and 600 mg linezolid administered intravenously every 12 hours for at least 5 days.</description>
          </group>
          <group group_id="O2">
            <title>Meropenem</title>
            <description>Participants received 2 g meropenem administered intravenously every 8 hours for 7 to 14 days and 600 mg linezolid administered intravenously every 12 hours for at least 5 days.</description>
          </group>
        </group_list>
        <measure>
          <title>All-cause Mortality Rate at the End of Study</title>
          <description>The all-cause mortality rate during both the treatment and follow-up period (up to the end of study [EOS] visit) was calculated as the percentage of participants who experienced mortality, regardless of the cause, from the first infusion of study drug up to EOS. If a participant discontinued from the study before EOS and survival information was not available, then the survival status for this endpoint for the participant was considered unknown.</description>
          <population>Modified Intent-to-Treat Population; participants with known survival status.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="142"/>
                <count group_id="O2" value="146"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.8"/>
                    <measurement group_id="O2" value="23.3"/>
                  </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>Other</non_inferiority_type>
            <param_type>Treatment Difference</param_type>
            <param_value>3.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.3</ci_lower_limit>
            <ci_upper_limit>13.4</ci_upper_limit>
            <estimate_desc>Treatment difference (cefiderocol - meropenem) was the adjusted estimate of the difference in the ACM rate at EOS based on Cochran-Mantel Haenszel weights using APACHE II score (≤ 15 and ≥ 16) as the stratification factor.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Hospitalization Time</title>
        <description>The length of hospital stay attributable to the study-qualifying infection.</description>
        <time_frame>From first dose of study drug to test of cure (7 days after end of treatment; equivalent to Study Day 14 to 21) and to follow-up (14 days after the end of treatment; Day 21 to 28)</time_frame>
        <population>Modified Intent-to-Treat Population</population>
        <group_list>
          <group group_id="O1">
            <title>Cefiderocol</title>
            <description>Participants received 2 g cefiderocol administered intravenously every 8 hours for 7 to 14 days and 600 mg linezolid administered intravenously every 12 hours for at least 5 days.</description>
          </group>
          <group group_id="O2">
            <title>Meropenem</title>
            <description>Participants received 2 g meropenem administered intravenously every 8 hours for 7 to 14 days and 600 mg linezolid administered intravenously every 12 hours for at least 5 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Hospitalization Time</title>
          <description>The length of hospital stay attributable to the study-qualifying infection.</description>
          <population>Modified Intent-to-Treat Population</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="145"/>
                <count group_id="O2" value="147"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Test of Cure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.54" spread="7.81"/>
                    <measurement group_id="O2" value="11.47" spread="7.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follow-up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.49" spread="10.06"/>
                    <measurement group_id="O2" value="12.98" spread="9.59"/>
                  </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>Comparison of Hospitalization time at test of cure</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9382</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison of hospitalization time at follow-up</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6552</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Treatment-Emergent Adverse Events</title>
        <description>The severity of each adverse event (AE) was graded by the investigator according to the following definitions:&#xD;
Mild: A finding or symptom is minor and does not interfere with usual daily activities.&#xD;
Moderate: The event causes discomfort and interferes with usual daily activity or affects clinical status.&#xD;
Severe: The event causes an interruption of the participant's usual daily activities or has a clinically significant effect.&#xD;
The relationship of each AE to the study treatment was determined by the investigator based on whether the AE could be reasonably explained as having been caused by the study drug (treatment related AE [TRAE]).&#xD;
An SAE is defined as any AE occurring at any dose that resulted in any of the following outcomes:&#xD;
Death&#xD;
Life-threatening condition&#xD;
Hospitalization or prolongation of existing hospitalization for treatment&#xD;
Persistent or significant disability/incapacity&#xD;
Congenital anomaly/birth defect&#xD;
Other medically important condition</description>
        <time_frame>From first dose of study drug through the end of study, up to 42 days.</time_frame>
        <population>The safety population included all randomized participants who received at least 1 dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Cefiderocol</title>
            <description>Participants received 2 g cefiderocol administered intravenously every 8 hours for 7 to 14 days and 600 mg linezolid administered intravenously every 12 hours for at least 5 days.</description>
          </group>
          <group group_id="O2">
            <title>Meropenem</title>
            <description>Participants received 2 g meropenem administered intravenously every 8 hours for 7 to 14 days and 600 mg linezolid administered intravenously every 12 hours for at least 5 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-Emergent Adverse Events</title>
          <description>The severity of each adverse event (AE) was graded by the investigator according to the following definitions:&#xD;
Mild: A finding or symptom is minor and does not interfere with usual daily activities.&#xD;
Moderate: The event causes discomfort and interferes with usual daily activity or affects clinical status.&#xD;
Severe: The event causes an interruption of the participant's usual daily activities or has a clinically significant effect.&#xD;
The relationship of each AE to the study treatment was determined by the investigator based on whether the AE could be reasonably explained as having been caused by the study drug (treatment related AE [TRAE]).&#xD;
An SAE is defined as any AE occurring at any dose that resulted in any of the following outcomes:&#xD;
Death&#xD;
Life-threatening condition&#xD;
Hospitalization or prolongation of existing hospitalization for treatment&#xD;
Persistent or significant disability/incapacity&#xD;
Congenital anomaly/birth defect&#xD;
Other medically important condition</description>
          <population>The safety population included all randomized participants who received at least 1 dose of study treatment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="148"/>
                <count group_id="O2" value="150"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any adverse event</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="130"/>
                    <measurement group_id="O2" value="129"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mild adverse events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                    <measurement group_id="O2" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate adverse events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41"/>
                    <measurement group_id="O2" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe adverse events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56"/>
                    <measurement group_id="O2" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment-related adverse events</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>Serious adverse events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54"/>
                    <measurement group_id="O2" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment-related serious adverse events</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>AEs leading to discontinuation of study drug</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TRAE leading to discontinuation of study drug</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adverse events leading to death</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39"/>
                    <measurement group_id="O2" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From first dose of study drug through the end of study, up to 42 days.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Cefiderocol</title>
          <description>Participants received 2 g cefiderocol administered intravenously every 8 hours for 7 to 14 days and 600 mg linezolid administered intravenously every 12 hours for at least 5 days.</description>
        </group>
        <group group_id="E2">
          <title>Meropenem</title>
          <description>Participants received 2 g meropenem administered intravenously every 8 hours for 7 to 14 days and 600 mg linezolid administered intravenously every 12 hours for at least 5 days.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA version 18.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="39" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="35" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="54" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="45" subjects_at_risk="150"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Coagulopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Disseminated intravascular coagulation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Haemorrhagic anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="150"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Cardiac failure acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Cardio-respiratory arrest</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Cardiogenic shock</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Cardiopulmonary failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Cardiovascular disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Cardiovascular insufficiency</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Left ventricular dysfunction</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="150"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal wall haematoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Acute abdomen</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Gastric haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Intestinal infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Intestinal ischaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="150"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>General physical health deterioration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Multiple organ dysfunction syndrome</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Sudden death</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Systemic inflammatory response syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="150"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Hepatic function abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Hepatocellular injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="150"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Acinetobacter bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Bacterial sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Brain abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Lung infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Meningitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Meningoencephalitis bacterial</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Pneumonia bacterial</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Pneumonia necrotising</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Pseudomonas infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Septic encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Spinal cord infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Systemic candida</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="150"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Splenic rupture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Subarachnoid haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="150"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Hepatic enzyme increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Liver function test abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Liver function test increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="150"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Hypovolaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Lactic acidosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="150"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Lung cancer metastatic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="150"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Autonomic nervous system imbalance</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Brain injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Brain oedema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Cerebral ischaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Hypoxic-ischaemic encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Intracranial pressure increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Lacunar stroke</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Metabolic encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Status epilepticus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Stroke in evolution</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="150"/>
              </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" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="150"/>
              </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" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Bronchopleural fistula</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Pneumonia aspiration</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Pneumothorax spontaneous</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Pulmonary artery thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Pulmonary congestion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Pulmonary hypertension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Pulmonary oedema</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Respiratory distress</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Stridor</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="150"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetic foot</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="150"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Leg amputation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="150"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Femoral artery embolism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Hypovolaemic shock</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Peripheral vascular disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Shock haemorrhagic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="150"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2</frequency_threshold>
        <default_vocab>MedDRA version 18.1</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="119" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="123" subjects_at_risk="150"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Thrombocytosis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Iron deficiency anaemia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="150"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="150"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="150"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="150"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatocellular injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="150"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Clostridium difficile infection</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Urinary tract infection fungal</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Tracheobronchitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="150"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Post procedural haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="150"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Gamma-glutamyltransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Hepatic enzyme increased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Amylase increased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="150"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="23" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Hypoalbuminaemia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Hypocalcaemia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Hypoproteinaemia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Hyperuricaemia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Gout</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Metabolic alkalosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Electrolyte imbalance</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="150"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="150"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Agitation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="150"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Hydrothorax</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Pulmonary congestion</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="150"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Decubitus ulcer</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="150"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Phlebitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="150"/>
              </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 sponsor can embargo results from a PI's center until the combined results from the completed study have been published in full or the sponsor confirms there will be no multicenter study publication. Results communications must be provided to the sponsor for review at least 60 days before submission for publication. By written request, the sponsor can extend the embargo up to an additional 60 days. The sponsor cannot require changes to scientific content and cannot further extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Shionogi Clinical Trials Administrator</name_or_title>
      <organization>Shionogi Inc.</organization>
      <phone>800-849-9707</phone>
      <email>shionogiclintrials-admin@shionogi.co.jp</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/NCT03032380
org study id: 1615R2132
secondary id: 2016-003020-23
nct id: NCT03032380
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The primary objective of this study is to compare all-cause mortality at Day 14 in
      participants receiving cefiderocol with participants receiving the comparator, meropenem, in
      adults with hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial
      pneumonia (VABP), or healthcare-associated bacterial pneumonia (HCABP) caused by
      Gram-negative pathogens.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: All-cause Mortality Rate at Day 14
time frame: From first dose of study drug to Day 14
description: The all-cause mortality (ACM) rate at Day 14 was calculated as the percentage of participants in each treatment group who experienced mortality, regardless of the cause, from the first infusion of study drug up to Day 14.
The Modified Intent-to-Treat Population included all randomized participants who met either of the following criteria:
Evidence of Gram-negative infection of the lower respiratory tract based on a culture, Gram-stain, or other diagnostic test
Evidence of a lower respiratory tract infection but culture or other diagnostic tests did not provide a microbiologic diagnosis
measure: Percentage of Participants With Microbiologic Eradication at Test of Cure (TOC)
time frame: Test of cure (7 days after end of treatment; equivalent to Study Day 14 to 21)
description: Lower respiratory tract specimens (eg, sputum, endotracheal aspiration [ETA], endobronchial culture specimens collected by bronchoalveolar lavage [BAL], or protected specimen brush [PSB], lung biopsy tissue, pleural effusions, etc) were sent to the local microbiology laboratory for isolation and identification of pathogens.
Microbiological outcome by Baseline pathogen at TOC was determined by the sponsor as either Eradication, Persistence, or Indeterminate. Overall per-participant microbiological outcome was determined based on the individual microbiological outcomes for each Baseline pathogen.
Eradication: Absence of all Baseline Gram-negative pathogens from an appropriate clinical specimen (sputum, tracheal aspirate, bronchoalveolar lavage (BAL) fluid, protected specimen brush, pleural fluid, or lung biopsy). If it was not possible to obtain an appropriate clinical culture, and the participant had a successful clinical outcome, the response was presumed as eradication.
measure: Percentage of Participants With Clinical Cure at Test of Cure
time frame: Test of cure (7 days after the end of treatment; equivalent to Study Day 14 to 21)
description: Clinical outcome was assessed by the investigator as either Clinical Cure, Clinical Failure, or Indeterminate.
Clinical Cure: Resolution or substantial improvement of Baseline signs and symptoms of pneumonia, including a reduction in Sequential Organ Failure Assessment (SOFA) and Clinical Pulmonary Infection Score (CPIS) scores, and improvement or lack of progression of chest radiographic abnormalities such that no additional antibacterial therapy was required for the treatment of the current infection.
measure: Percentage of Participants With Clinical Cure at Early Assessment (EA)
time frame: Early assessment (Day 3-4 after the start of treatment)
description: Clinical outcome was assessed by the investigator as either Clinical Cure, Clinical Failure, or Indeterminate.
Clinical Cure: Resolution or substantial improvement of Baseline signs and symptoms of pneumonia, including a reduction in Sequential Organ Failure Assessment (SOFA) and Clinical Pulmonary Infection Score (CPIS) scores, and improvement or lack of progression of chest radiographic abnormalities such that no additional antibacterial therapy was required for the treatment of the current infection.
measure: Percentage of Participants With Clinical Cure at End of Treatment (EOT)
time frame: End of treatment (Day 7 to 14)
description: Clinical outcome was assessed by the investigator as either Clinical Cure, Clinical Failure, or Indeterminate.
Clinical Cure: Resolution or substantial improvement of Baseline signs and symptoms of pneumonia, including a reduction in Sequential Organ Failure Assessment (SOFA) and Clinical Pulmonary Infection Score (CPIS) scores, and improvement or lack of progression of chest radiographic abnormalities such that no additional antibacterial therapy was required for the treatment of the current infection.
measure: Percentage of Participants With Sustained Clinical Cure at Follow-up (FU)
time frame: Follow-up (14 days after the end of treatment; Day 21 to 28)
description: Clinical outcome was assessed by the investigator at follow-up as either Sustained Clinical Cure, Relapse, or Indeterminate.
Sustained Clinical Cure: Continued resolution or substantial improvement of Baseline signs and symptoms of pneumonia, such that no antibacterial therapy was required for the treatment of pneumonia in a participant assessed as cured at TOC.
measure: Percentage of Participants With Microbiologic Eradication at Early Assessment
time frame: Early Assessment, Days 3 to 4
description: Microbiological outcome by Baseline pathogen at Early Assessment was determined by the sponsor as either Eradication, Persistence, or Indeterminate. Overall per-participant microbiological outcome was determined based on the individual microbiological outcomes for each Baseline pathogen.
Eradication: Absence of all Baseline Gram-negative pathogens from an appropriate clinical specimen (sputum, tracheal aspirate, BAL fluid, protected specimen brush, pleural fluid, or lung biopsy). If it was not possible to obtain an appropriate clinical culture, and the participant had a successful clinical outcome, the response was presumed as eradication.
measure: Percentage of Participants With Microbiologic Eradication at End of Treatment
time frame: End of treatment, Day 7 to 14
description: Microbiological outcome by Baseline pathogen at End of Treatment was determined by the sponsor as either: Eradication, Persistence, or Indeterminate. Overall per-participant microbiological outcome was determined based on the individual microbiological outcomes for each Baseline pathogen.
Eradication: Absence of all Baseline Gram-negative pathogens from an appropriate clinical specimen (sputum, tracheal aspirate, BAL fluid, protected specimen brush, pleural fluid, or lung biopsy). If it was not possible to obtain an appropriate clinical culture, and the participant had a successful clinical outcome, the response was presumed as eradication.
measure: Percentage of Participants With Sustained Microbiologic Eradication at Follow-up
time frame: Follow-up (14 days after the end of treatment, Days 21 to 28)
description: Microbiological outcome by Baseline pathogen at Follow-up was determined by the sponsor as either Sustained Eradication, Persistence, Recurrence, or Indeterminate. Overall per-participant microbiological outcome was determined based on the individual microbiological outcomes for each Baseline pathogen.
Sustained eradication: Absence of all Baseline Gram-negative pathogens from an appropriate clinical specimen (sputum, tracheal aspirate, BAL fluid, protected specimen brush, pleural fluid, or lung biopsy) after TOC. If it was not possible to obtain an appropriate clinical culture and the participant had a successful clinical response after TOC, the response was presumed to be eradication.
measure: All-cause Mortality Rate at Day 28
time frame: From first dose of study drug to Day 28
description: The all-cause mortality (ACM) rate at Day 28 was calculated as the percentage of participants who experienced mortality, regardless of the cause, from the first dose of study drug up to Day 28.
measure: All-cause Mortality Rate at the End of Study
time frame: From first dose of study drug through end of study (28 days after end of treatment, up to 42 days)
description: The all-cause mortality rate during both the treatment and follow-up period (up to the end of study [EOS] visit) was calculated as the percentage of participants who experienced mortality, regardless of the cause, from the first infusion of study drug up to EOS. If a participant discontinued from the study before EOS and survival information was not available, then the survival status for this endpoint for the participant was considered unknown.
measure: Total Hospitalization Time
time frame: From first dose of study drug to test of cure (7 days after end of treatment; equivalent to Study Day 14 to 21) and to follow-up (14 days after the end of treatment; Day 21 to 28)
description: The length of hospital stay attributable to the study-qualifying infection.
measure: Number of Participants With Treatment-Emergent Adverse Events
time frame: From first dose of study drug through the end of study, up to 42 days.
description: The severity of each adverse event (AE) was graded by the investigator according to the following definitions:
Mild: A finding or symptom is minor and does not interfere with usual daily activities.
Moderate: The event causes discomfort and interferes with usual daily activity or affects clinical status.
Severe: The event causes an interruption of the participant's usual daily activities or has a clinically significant effect.
The relationship of each AE to the study treatment was determined by the investigator based on whether the AE could be reasonably explained as having been caused by the study drug (treatment related AE [TRAE]).
An SAE is defined as any AE occurring at any dose that resulted in any of the following outcomes:
Death
Life-threatening condition
Hospitalization or prolongation of existing hospitalization for treatment
Persistent or significant disability/incapacity
Congenital anomaly/birth defect
Other medically important condition
arm group label: Cefiderocol
arm group type: Experimental
description: Participants will receive 2 g cefiderocol administered intravenously every 8 hours for 7 to 14 days and 600 mg linezolid administered intravenously every 12 hours for at least 5 days.
arm group label: Meropenem
arm group type: Active Comparator
description: Participants will receive 2 g meropenem administered intravenously every 8 hours for 7 to 14 days and 600 mg linezolid administered intravenously every 12 hours for at least 5 days.
intervention type: Drug
intervention name: Cefiderocol
description: 2000 mg intravenously every 8 hours for a period of 7 to14 days (dosage adjustment is necessary based on renal function)
arm group label: Cefiderocol
other name: S-649266
intervention type: Drug
intervention name: Meropenem
description: 2000 mg intravenously every 8 hours for a period of 7 to 14 days (dosage adjustment is necessary based on renal function)
arm group label: Meropenem
other name: Merrem®
intervention type: Drug
intervention name: Linezolid
description: 600 mg of linezolid administered intravenously over 30 minutes to 2 hours, every 12 hours.
arm group label: Cefiderocol
arm group label: Meropenem
other name: Zyvox®
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Shionogi Clinical Trials Administrator Clinical Support Help Line
role: Study Director
affiliation: Shionogi
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country: Belgium
country: Canada
country: Czechia
country: Estonia
country: France
country: Georgia
country: Germany
country: Hungary
country: Israel
country: Japan
country: Latvia
country: Philippines
country: Puerto Rico
country: Russian Federation
country: Serbia
country: Spain
country: Taiwan
country: Ukraine
country: United States
country: Colombia
responsible party type: Sponsor
mesh term: Pneumonia
mesh term: Pneumonia, Ventilator-Associated
mesh term: Healthcare-Associated Pneumonia
mesh term: Meropenem
mesh term: Linezolid
sharing ipd: No
provided document: 
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certain agreements: 
point of contact: 