<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/NCT04497987</url>
  </required_header>
  <id_info>
    <org_study_id>18063</org_study_id>
    <secondary_id>J2X-MC-PYAD</secondary_id>
    <secondary_id>CoVPN #3501</secondary_id>
    <nct_id>NCT04497987</nct_id>
  </id_info>
  <brief_title>A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in Preventing SARS-CoV-2 Infection and COVID-19 in Nursing Home Residents and Staff</brief_title>
  <acronym>BLAZE-2</acronym>
  <official_title>A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of LY3819253 Alone and in Combination With LY3832479 in Preventing SARS-CoV-2 Infection and COVID-19 in Skilled Nursing and Assisted Living Facility Residents and Staff; a NIAID and Lilly Collaborative Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eli Lilly and Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Allergy and Infectious Diseases (NIAID)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>AbCellera Biologics Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shanghai Junshi Bioscience Co., Ltd.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Eli Lilly and Company</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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate whether LY3819253 given alone and with LY3832479&#xD;
      prevent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and&#xD;
      coronavirus disease - 2019 (COVID-19). Facility staff and residents in contracted skilled&#xD;
      nursing and assisted living facility networks with a high risk of SARS-CoV-2 exposure will&#xD;
      receive LY3819253, LY3819253 and LY3832479, or placebo via an injection into a vein. Samples&#xD;
      will be taken from the nose. Blood samples will be drawn. Participation could last up to 25&#xD;
      weeks and may include up to 19 visits.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2, 2020</start_date>
  <completion_date type="Actual">May 20, 2021</completion_date>
  <primary_completion_date type="Actual">January 16, 2021</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With COVID-19</measure>
    <time_frame>Week 8 after randomization</time_frame>
    <description>The endpoint for the primary analysis is defined as the first occurrence of coronavirus disease - 2019 (COVID-19), defined as the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by reverse transcription - polymerase chain reaction (RT-PCR) AND mild or worse disease severity within 21 days of detection, by Day 57 (8 weeks after randomization). The participant needed to test positive on or prior to week 8, and they needed to develop their symptoms on or after their positive test date, but no later than 21 days after their positive swab OR Week 8, whichever comes first. Logistic regression model was used which includes occurrence of a primary endpoint event as the response variable, and treatment and stratification factors such as facility as explanatory variables.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Moderate or Worse Severity COVID-19</measure>
    <time_frame>Week 8 after randomization</time_frame>
    <description>The endpoint defined as the detection of SARS-CoV-2 by polymerase chain reaction (RT-PCR) AND moderate or worse disease severity within 21 days of detection, by Day 57 (Week 8) were summarized by treatment group. The participant needed to test positive on or prior to week 8, and they needed to develop their symptoms on or after their positive test date, but no later than 21 days after their positive swab OR Week 8, whichever comes first. Logistic regression model was used which includes occurrence of a primary endpoint event as the response variable, and treatment and stratification factors such as facility as explanatory variables.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With SARS-CoV-2</measure>
    <time_frame>Week 4</time_frame>
    <description>Percentage of Participants with SARS-CoV-2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Are Hospitalized or Have Died Due to COVID-19</measure>
    <time_frame>Week 8</time_frame>
    <description>Percentage of Participants Who are Hospitalized or Have Died due to COVID-19.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Experience COVID-19-Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death</measure>
    <time_frame>Week 8</time_frame>
    <description>Percentage of Participants who Experience COVID-19-Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Die Due to COVID-19</measure>
    <time_frame>Week 8</time_frame>
    <description>Percentage of Participants Who Die Due to COVID-19.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics (PK): Mean Concentration of Bamlanivimab Administered Alone</measure>
    <time_frame>Day 29, 57, 85, 141 and 169</time_frame>
    <description>Pharmacokinetics (PK): Mean Concentration of bamlanivimab Administered Alone.</description>
  </secondary_outcome>
  <number_of_arms>9</number_of_arms>
  <enrollment type="Actual">1180</enrollment>
  <condition>COVID-19</condition>
  <condition>SARS-CoV2</condition>
  <arm_group>
    <arm_group_label>Bamlanivimab (Part 1)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received single Intravenous (IV) infusion of 4200 milligrams (mg) bamlanivimab.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo (Part 1)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants received single IV infusion of Placebo.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bamlanivimab (Part 2-Prevention)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Enrollment for Part 2 was not initiated because the efficacy of Bamlanivimab 4200 mg observed in Part 1 significantly diminished the feasibility of enrolling Part 2.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bamlanivimab + Etesevimab (Part 2-Prevention)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Enrollment for Part 2 was not initiated because the efficacy of Bamlanivimab 4200 mg observed in Part 1 significantly diminished the feasibility of enrolling Part 2.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Comparator: Placebo (Part 2-Prevention)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Enrollment for Part 2 was not initiated because the efficacy of Bamlanivimab 4200 mg observed in Part 1 significantly diminished the feasibility of enrolling Part 2.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bamlanivimab (Part 2 - Treatment)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Enrollment for Part 2 was not initiated because the efficacy of Bamlanivimab 4200 mg observed in Part 1 significantly diminished the feasibility of enrolling Part 2.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bamlanivimab + Etesevimab (Part 2- Treatment)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Enrollment for Part 2 was not initiated because the efficacy of Bamlanivimab 4200 mg observed in Part 1 significantly diminished the feasibility of enrolling Part 2.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bamlanivimab (Part 3)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Part 3 of the study is exploratory, conducted to study exploratory objectives and is not reported in this record.&#xD;
[Participants received single IV infusion of 700 mg bamlanivimab.]</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bamlanivimab + Etesevimab (Part 3)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Part 3 of the study is exploratory, conducted to study exploratory objectives and is not reported in this record.&#xD;
[Participants received single IV infusion of 700 mg bamlanivimab given with 1400 mg etesevimab.]</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bamlanivimab</intervention_name>
    <description>Administered IV.</description>
    <arm_group_label>Bamlanivimab (Part 1)</arm_group_label>
    <arm_group_label>Bamlanivimab (Part 2 - Treatment)</arm_group_label>
    <arm_group_label>Bamlanivimab (Part 2-Prevention)</arm_group_label>
    <arm_group_label>Bamlanivimab (Part 3)</arm_group_label>
    <arm_group_label>Bamlanivimab + Etesevimab (Part 2- Treatment)</arm_group_label>
    <arm_group_label>Bamlanivimab + Etesevimab (Part 2-Prevention)</arm_group_label>
    <arm_group_label>Bamlanivimab + Etesevimab (Part 3)</arm_group_label>
    <other_name>LY-CoV555</other_name>
    <other_name>LY3819253</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Administered IV.</description>
    <arm_group_label>Placebo (Part 1)</arm_group_label>
    <arm_group_label>Placebo Comparator: Placebo (Part 2-Prevention)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Etesevimab</intervention_name>
    <description>Administered IV.</description>
    <arm_group_label>Bamlanivimab + Etesevimab (Part 2- Treatment)</arm_group_label>
    <arm_group_label>Bamlanivimab + Etesevimab (Part 2-Prevention)</arm_group_label>
    <arm_group_label>Bamlanivimab + Etesevimab (Part 3)</arm_group_label>
    <other_name>LY-CoV016</other_name>
    <other_name>LY3832479</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Part 1 and Part 2: Resident or facility staff in a skilled nursing or assisted living&#xD;
             facility with at least one confirmed case of SARS-CoV-2 detection less than or equal&#xD;
             to (≤)7 days prior to randomization&#xD;
&#xD;
          -  Are men or non-pregnant women who agree to contraceptive requirements&#xD;
&#xD;
          -  Agree to the collection of nasal, mid-turbinate, oropharyngeal, and nasopharyngeal&#xD;
             swabs, and venous blood as specified in the schedule of activities&#xD;
&#xD;
          -  Have venous access sufficient to allow intravenous infusions and blood sampling&#xD;
&#xD;
          -  The participant or legally authorized representative give signed informed consent&#xD;
&#xD;
          -  Part 3 only: Resident or staff in a skilled nursing or assisted living facility who&#xD;
             satisfy at least one of the following at the time of screening&#xD;
&#xD;
               -  Are greater than or equal to (≥) 65 years of age&#xD;
&#xD;
               -  Have a body mass index (BMI) ≥ 35&#xD;
&#xD;
               -  Have chronic kidney disease&#xD;
&#xD;
               -  Have type 1 or type 2 diabetes&#xD;
&#xD;
               -  Have immunosuppressive disease&#xD;
&#xD;
               -  Are currently receiving immunosuppressive treatment, or&#xD;
&#xD;
               -  Are ≥ 55 years of age AND have&#xD;
&#xD;
                    -  cardiovascular disease, OR&#xD;
&#xD;
                    -  hypertension, OR&#xD;
&#xD;
                    -  chronic obstructive pulmonary disease or other chronic respiratory disease&#xD;
&#xD;
          -  Positive SARS-CoV-2 test and infusion within 10 days of symptom onset, OR positive&#xD;
             SARS-CoV-2 test and infusion within 10 days of testing if asymptomatic&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Parts 1 and 2:&#xD;
&#xD;
               -  Recovered from confirmed COVID-19 disease or asymptomatic infection&#xD;
&#xD;
               -  Prior history of a positive SARS-CoV-2 serology test&#xD;
&#xD;
               -  History of convalescent COVID-19 plasma treatment&#xD;
&#xD;
               -  Participation in a previous SARS-CoV-2 vaccine trial or received an approved&#xD;
                  SARS-CoV-2 vaccine&#xD;
&#xD;
               -  Previous receipt of SAR-CoV-2-specific monoclonal antibodies&#xD;
&#xD;
          -  Have any serious concomitant systemic disease, condition or disorder that, in the&#xD;
             opinion of the investigator, should preclude participation in this study&#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>Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)</last_name>
    <role>Study Director</role>
    <affiliation>Eli Lilly and Company</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Unv of AL Sch of Med Div of Infectious Diseases</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Care Access Research</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85023</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allergy and Asthma Clin of NW Ark</name>
      <address>
        <city>Bentonville</city>
        <state>Arkansas</state>
        <zip>72712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Care Access Research LLC</name>
      <address>
        <city>Huntington Beach</city>
        <state>California</state>
        <zip>92648</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alta Bates SMC</name>
      <address>
        <city>Oakland</city>
        <state>California</state>
        <zip>94609</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado-Anschultz Medical Campus</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NIAID</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NIAID</name>
      <address>
        <city>Decatur</city>
        <state>Georgia</state>
        <zip>30030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Belmont Village Lincoln Park</name>
      <address>
        <city>Lincoln Park</city>
        <state>Illinois</state>
        <zip>60614</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Family Medicine</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46260</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Louisville</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Care Access Rch Lake Charles</name>
      <address>
        <city>Lake Charles</city>
        <state>Louisiana</state>
        <zip>70601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tulane University School of Medicine</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70112 2715</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NIAID - National Institute of Allergy &amp; Infectious Diseases</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20892</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Care Access</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Paul IDA-CARe</name>
      <address>
        <city>Saint Paul</city>
        <state>Minnesota</state>
        <zip>55101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Care Access</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Mississippi Medical Center</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital &amp; Medical Center</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Care Access Research - Bronx</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10456</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NIAD</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Valley Medical Primary Care</name>
      <address>
        <city>Centerville</city>
        <state>Ohio</state>
        <zip>45459</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Univ of Cin College of Med</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OSU Med Intl Med Houston Ctr</name>
      <address>
        <city>Tulsa</city>
        <state>Oklahoma</state>
        <zip>74127</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Donahoe Manor</name>
      <address>
        <city>Bedford</city>
        <state>Pennsylvania</state>
        <zip>15522</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Belmont Village, West Univ</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Burke Internal Medicine and Research</name>
      <address>
        <city>Burke</city>
        <state>Virginia</state>
        <zip>22015</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://trials.lillytrialguide.com/en-US/trial/6hAC2UjP12uxz1fFWVGSKC</url>
    <description>A Study of LY3819253 (LY-CoV555) to Prevent SARS-CoV-2 Infection and COVID-19 in Nursing Home Residents and Staff (BLAZE-2)</description>
  </link>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>July 31, 2020</study_first_submitted>
  <study_first_submitted_qc>July 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <results_first_submitted>January 11, 2022</results_first_submitted>
  <results_first_submitted_qc>February 2, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">February 4, 2022</results_first_posted>
  <last_update_submitted>February 2, 2022</last_update_submitted>
  <last_update_submitted_qc>February 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Prevention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bamlanivimab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.</ipd_time_frame>
    <ipd_access_criteria>A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.</ipd_access_criteria>
    <ipd_url>https://vivli.org/</ipd_url>
  </patient_data>
  <provided_document_section>
    <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>January 22, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/87/NCT04497987/Prot_000.pdf</document_url>
    </provided_document>
    <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>December 7, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/87/NCT04497987/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This trial was planned as a 3-part study. Part 1 was to evaluate the efficacy and safety of bamlanivimab (BAM) in preventing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and coronavirus disease 2019 (COVID-19), compared with Placebo (PBO). Part 2 was to demonstrate superior efficacy of BAM and BAM + ETE over PBO in the prevention of COVID-19. Part 3 was exploratory cohort.</recruitment_details>
      <pre_assignment_details>Enrollment for Part 2 was not initiated because the efficacy of BAM 4200 mg observed in Part 1 significantly diminished the feasibility of enrolling Part 2.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Participants received single IV infusion of Placebo.</description>
        </group>
        <group group_id="P2">
          <title>4200 mg Bamlanivimab</title>
          <description>Participants received single IV infusion of 4200 milligrams (mg) bamlanivimab.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="592"/>
                <participants group_id="P2" count="588"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received at Least One Dose of Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="587"/>
                <participants group_id="P2" count="588"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Prevention Population</title>
              <participants_list>
                <participants group_id="P1" count="485"/>
                <participants group_id="P2" count="487"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treatment Population</title>
              <participants_list>
                <participants group_id="P1" count="68"/>
                <participants group_id="P2" count="66"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Serology Positive</title>
              <participants_list>
                <participants group_id="P1" count="36"/>
                <participants group_id="P2" count="35"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="493"/>
                <participants group_id="P2" count="521"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="99"/>
                <participants group_id="P2" count="67"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="17"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other - as reported by the investigator</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="16"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</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="35"/>
                <participants group_id="P2" count="21"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All randomized participants who received at least one dose of study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Participants received single IV infusion of Placebo.</description>
        </group>
        <group group_id="B2">
          <title>4200 mg Bamlanivimab</title>
          <description>Participants received single IV infusion of 4200 mg bamlanivimab.</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="587"/>
            <count group_id="B2" value="588"/>
            <count group_id="B3" value="1175"/>
          </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="52.2" spread="20.3"/>
                    <measurement group_id="B2" value="53.4" spread="20.7"/>
                    <measurement group_id="B3" value="52.8" spread="20.5"/>
                  </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="443"/>
                    <measurement group_id="B2" value="434"/>
                    <measurement group_id="B3" value="877"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="144"/>
                    <measurement group_id="B2" value="154"/>
                    <measurement group_id="B3" value="298"/>
                  </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="36"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="62"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="551"/>
                    <measurement group_id="B2" value="561"/>
                    <measurement group_id="B3" value="1112"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</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>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="52"/>
                    <measurement group_id="B2" value="48"/>
                    <measurement group_id="B3" value="100"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="515"/>
                    <measurement group_id="B2" value="519"/>
                    <measurement group_id="B3" value="1034"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="587"/>
                    <measurement group_id="B2" value="588"/>
                    <measurement group_id="B3" value="1175"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With COVID-19</title>
        <description>The endpoint for the primary analysis is defined as the first occurrence of coronavirus disease - 2019 (COVID-19), defined as the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by reverse transcription - polymerase chain reaction (RT-PCR) AND mild or worse disease severity within 21 days of detection, by Day 57 (8 weeks after randomization). The participant needed to test positive on or prior to week 8, and they needed to develop their symptoms on or after their positive test date, but no later than 21 days after their positive swab OR Week 8, whichever comes first. Logistic regression model was used which includes occurrence of a primary endpoint event as the response variable, and treatment and stratification factors such as facility as explanatory variables.</description>
        <time_frame>Week 8 after randomization</time_frame>
        <population>All randomized participants from prevention population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received single IV infusion of Placebo.</description>
          </group>
          <group group_id="O2">
            <title>4200mg Bamlanivimab</title>
            <description>Participants received single IV infusion of 4200mg bamlanivimab.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With COVID-19</title>
          <description>The endpoint for the primary analysis is defined as the first occurrence of coronavirus disease - 2019 (COVID-19), defined as the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by reverse transcription - polymerase chain reaction (RT-PCR) AND mild or worse disease severity within 21 days of detection, by Day 57 (8 weeks after randomization). The participant needed to test positive on or prior to week 8, and they needed to develop their symptoms on or after their positive test date, but no later than 21 days after their positive swab OR Week 8, whichever comes first. Logistic regression model was used which includes occurrence of a primary endpoint event as the response variable, and treatment and stratification factors such as facility as explanatory variables.</description>
          <population>All randomized participants from prevention population.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="485"/>
                <count group_id="O2" value="487"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.7" lower_limit="12.5" upper_limit="18.9"/>
                    <measurement group_id="O2" value="8.3" lower_limit="5.8" upper_limit="10.7"/>
                  </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>
            <p_value>&lt;0.001</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.40</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.26</ci_lower_limit>
            <ci_upper_limit>0.63</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Moderate or Worse Severity COVID-19</title>
        <description>The endpoint defined as the detection of SARS-CoV-2 by polymerase chain reaction (RT-PCR) AND moderate or worse disease severity within 21 days of detection, by Day 57 (Week 8) were summarized by treatment group. The participant needed to test positive on or prior to week 8, and they needed to develop their symptoms on or after their positive test date, but no later than 21 days after their positive swab OR Week 8, whichever comes first. Logistic regression model was used which includes occurrence of a primary endpoint event as the response variable, and treatment and stratification factors such as facility as explanatory variables.</description>
        <time_frame>Week 8 after randomization</time_frame>
        <population>All randomized participants from prevention population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received single IV infusion of Placebo.</description>
          </group>
          <group group_id="O2">
            <title>4200mg Bamlanivimab</title>
            <description>Participants received single IV infusion of 4200mg bamlanivimab.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Moderate or Worse Severity COVID-19</title>
          <description>The endpoint defined as the detection of SARS-CoV-2 by polymerase chain reaction (RT-PCR) AND moderate or worse disease severity within 21 days of detection, by Day 57 (Week 8) were summarized by treatment group. The participant needed to test positive on or prior to week 8, and they needed to develop their symptoms on or after their positive test date, but no later than 21 days after their positive swab OR Week 8, whichever comes first. Logistic regression model was used which includes occurrence of a primary endpoint event as the response variable, and treatment and stratification factors such as facility as explanatory variables.</description>
          <population>All randomized participants from prevention population.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="485"/>
                <count group_id="O2" value="487"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.7" lower_limit="11.5" upper_limit="17.8"/>
                    <measurement group_id="O2" value="8.1" lower_limit="5.6" upper_limit="10.5"/>
                  </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>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.43</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.27</ci_lower_limit>
            <ci_upper_limit>0.67</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With SARS-CoV-2</title>
        <description>Percentage of Participants with SARS-CoV-2.</description>
        <time_frame>Week 4</time_frame>
        <population>All randomized participants from prevention population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received single IV infusion of Placebo.</description>
          </group>
          <group group_id="O2">
            <title>4200mg Bamlanivimab</title>
            <description>Participants received single IV infusion of 4200mg bamlanivimab.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With SARS-CoV-2</title>
          <description>Percentage of Participants with SARS-CoV-2.</description>
          <population>All randomized participants from prevention population.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="485"/>
                <count group_id="O2" value="487"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.1" lower_limit="19.4" upper_limit="26.9"/>
                    <measurement group_id="O2" value="17.8" lower_limit="14.4" upper_limit="21.2"/>
                  </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>
            <p_value>0.021</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.66</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.46</ci_lower_limit>
            <ci_upper_limit>0.94</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Are Hospitalized or Have Died Due to COVID-19</title>
        <description>Percentage of Participants Who are Hospitalized or Have Died due to COVID-19.</description>
        <time_frame>Week 8</time_frame>
        <population>All randomized participants from prevention population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received single IV infusion of Placebo.</description>
          </group>
          <group group_id="O2">
            <title>4200mg Bamlanivimab</title>
            <description>Participants received single IV infusion of 4200mg bamlanivimab.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Are Hospitalized or Have Died Due to COVID-19</title>
          <description>Percentage of Participants Who are Hospitalized or Have Died due to COVID-19.</description>
          <population>All randomized participants from prevention population.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="485"/>
                <count group_id="O2" value="487"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4" lower_limit="0.4" upper_limit="2.5"/>
                    <measurement group_id="O2" value="0.4" lower_limit="0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Experience COVID-19-Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death</title>
        <description>Percentage of Participants who Experience COVID-19-Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death.</description>
        <time_frame>Week 8</time_frame>
        <population>All randomized participants from prevention population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received single IV infusion of Placebo.</description>
          </group>
          <group group_id="O2">
            <title>4200mg Bamlanivimab</title>
            <description>Participants received single IV infusion of 4200mg bamlanivimab.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Experience COVID-19-Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death</title>
          <description>Percentage of Participants who Experience COVID-19-Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death.</description>
          <population>All randomized participants from prevention population.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="485"/>
                <count group_id="O2" value="487"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4" lower_limit="0.4" upper_limit="2.5"/>
                    <measurement group_id="O2" value="0.6" lower_limit="0" upper_limit="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Die Due to COVID-19</title>
        <description>Percentage of Participants Who Die Due to COVID-19.</description>
        <time_frame>Week 8</time_frame>
        <population>All randomized participants from prevention population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received single IV infusion of Placebo.</description>
          </group>
          <group group_id="O2">
            <title>4200mg Bamlanivimab</title>
            <description>Participants received single IV infusion of 4200mg bamlanivimab.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Die Due to COVID-19</title>
          <description>Percentage of Participants Who Die Due to COVID-19.</description>
          <population>All randomized participants from prevention population.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="485"/>
                <count group_id="O2" value="487"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" lower_limit="0" upper_limit="1.6"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetics (PK): Mean Concentration of Bamlanivimab Administered Alone</title>
        <description>Pharmacokinetics (PK): Mean Concentration of bamlanivimab Administered Alone.</description>
        <time_frame>Day 29, 57, 85, 141 and 169</time_frame>
        <population>All randomized participants who received at least one dose of bamlanivimab and had evaluable PK data.</population>
        <group_list>
          <group group_id="O1">
            <title>4200mg Bamlanivimab</title>
            <description>Participants received single IV infusion of 4200mg bamlanivimab.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (PK): Mean Concentration of Bamlanivimab Administered Alone</title>
          <description>Pharmacokinetics (PK): Mean Concentration of bamlanivimab Administered Alone.</description>
          <population>All randomized participants who received at least one dose of bamlanivimab and had evaluable PK data.</population>
          <units>microgram per milliliter (µg/mL)</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="557"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="557"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="162" spread="44.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 57</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="536"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.8" spread="59.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 85</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="369"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.4" spread="61.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 141</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="137"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.5" spread="46.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 169</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.1" spread="42.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline, up to 9 Months</time_frame>
      <desc>All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Participants received single IV infusion of Placebo.</description>
        </group>
        <group group_id="E2">
          <title>4200mg Bamlanivimab</title>
          <description>Participants received single IV infusion of 4200mg bamlanivimab.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 24.0</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="21" subjects_at_risk="587"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="30" subjects_at_risk="587"/>
                <counts group_id="E2" subjects_affected="39" subjects_at_risk="588"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Iron deficiency anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Cardiac failure acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="587"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Cardio-respiratory arrest</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Cardiomyopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Thyrotoxic crisis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Mouth haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Oesophageal ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Gait disturbance</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Sudden death</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Bile duct stone</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Hepatic cirrhosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Acquired immunodeficiency syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Clostridium difficile infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Escherichia bacteraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Escherichia urinary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Groin abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Osteomyelitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="587"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="587"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="588"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Hip fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Injury corneal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Limb injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Multiple injuries</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Open globe injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Road traffic accident</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Spinal compression fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Lumbar spinal stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Dementia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Metabolic encephalopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="588"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Abortion spontaneous</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="443"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="434"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression suicidal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Mental status changes</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Post-traumatic stress disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>End stage renal disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Renal artery stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Ureterolithiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Pneumonia aspiration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Pulmonary mass</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Ingrowing nail</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypovolaemic shock</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Lymphoedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 24.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="147" subjects_at_risk="587"/>
                <counts group_id="E2" subjects_affected="145" subjects_at_risk="588"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Leukocytosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Atrial thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Cardiomegaly</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Sinus bradycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Ventricular fibrillation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Eustachian tube dysfunction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Excessive cerumen production</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Tinnitus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="588"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Adrenal insufficiency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Hyperparathyroidism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Eye discharge</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Eye pruritus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Retinal detachment</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Abdominal hernia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="587"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Anal incontinence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Aphthous ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="587"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Dental caries</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="587"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Faecaloma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Gastric disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Glossodynia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Large intestine polyp</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Mouth ulceration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Oesophagitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Oral pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Upper gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Face oedema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Feeling hot</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Infusion site haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Injection site extravasation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Oedema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Puncture site haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Swelling face</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatic cirrhosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Hepatic function abnormal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Food allergy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Serum sickness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Candida infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Clostridium difficile infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Device related infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Ear infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="587"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Endocarditis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Eye infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Fungal infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Gastrointestinal bacterial infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Kidney infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Labyrinthitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Localised infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Oral candidiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Oral herpes</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Osteomyelitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Pharyngitis streptococcal</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Pilonidal cyst</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="587"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="587"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Subcutaneous abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Tooth abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Tooth infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="22" subjects_affected="20" subjects_at_risk="587"/>
                <counts group_id="E2" events="13" subjects_affected="11" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Vaginal infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="434"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Animal bite</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Animal scratch</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Concussion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="587"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="12" subjects_affected="9" subjects_at_risk="587"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Foot fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Head injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Humerus fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Joint dislocation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Joint injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Ligament sprain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Limb injury</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Lower limb fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Lumbar vertebral fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Muscle strain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Skin laceration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Soft tissue injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Spinal compression fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Tibia fracture</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Tooth fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Vaccination complication</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Wrist fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Amylase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Blood albumin decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Blood glucose increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Blood potassium decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Blood sodium decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Blood urea increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Brain natriuretic peptide increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Breath sounds abnormal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>C-reactive protein increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Capillary nail refill test abnormal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Gamma-glutamyltransferase increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Haemoglobin increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Hepatic enzyme increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>International normalised ratio increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Neutrophil count increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Procalcitonin increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Smear cervix abnormal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="434"/>
              </event>
              <event>
                <sub_title>Troponin increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>White blood cell count increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Dyslipidaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Glucose tolerance impaired</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Gout</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Hypercalcaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Hyperlipidaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Hyperproteinaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Hypoalbuminaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Metabolic acidosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Vitamin b complex deficiency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Vitamin d deficiency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="588"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="587"/>
                <counts group_id="E2" events="8" subjects_affected="7" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="587"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Bursitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Coccydynia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Inguinal mass</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Intervertebral disc degeneration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Intervertebral disc protrusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Joint effusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Joint range of motion decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Joint swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="587"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Osteonecrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="587"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Sjogren's syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Spinal stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Trochlear dysplasia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Cervix carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="443"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="434"/>
              </event>
              <event>
                <sub_title>Plasma cell myeloma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Prostate cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="154"/>
              </event>
              <event>
                <sub_title>Seborrhoeic keratosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Bell's palsy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Carpal tunnel syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Cubital tunnel syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="587"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Dizziness postural</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="587"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Metabolic encephalopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Sciatica</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anorgasmia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Anxiety disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Delusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Generalised anxiety disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Mental status changes</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Bladder spasm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Renal impairment</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Urinary tract obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Breast mass</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Dysmenorrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="434"/>
              </event>
              <event>
                <sub_title>Ovarian cyst ruptured</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="443"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="434"/>
              </event>
              <event>
                <sub_title>Vulvovaginal pruritus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="434"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Dysphonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="587"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Paranasal sinus discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Pharyngeal paraesthesia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Pulmonary fibrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Sinus congestion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Sinus pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Sleep apnoea syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Sneezing</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Wheezing</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </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" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Dermatitis allergic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Dermatitis contact</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Diabetic foot</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Ecchymosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Night sweats</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Skin exfoliation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Skin ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Skin wrinkling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Stasis dermatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="588"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Dental operation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Knee arthroplasty</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Retinopexy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Salpingo-oophorectomy unilateral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="443"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="434"/>
              </event>
              <event>
                <sub_title>Sinus operation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Spinal laminectomy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Tooth extraction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Aortic arteriosclerosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Flushing</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="587"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="587"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="587"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="588"/>
              </event>
              <event>
                <sub_title>Lymphoedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="587"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="588"/>
              </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 only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Chief Medical Officer</name_or_title>
      <organization>Eli Lilly and Company</organization>
      <phone>800-545-5979</phone>
      <email>ClinicalTrials.gov@lilly.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04497987
org study id: 18063
secondary id: J2X-MC-PYAD
secondary id: CoVPN #3501
nct id: NCT04497987
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The purpose of this study is to evaluate whether LY3819253 given alone and with LY3832479
      prevent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and
      coronavirus disease - 2019 (COVID-19). Facility staff and residents in contracted skilled
      nursing and assisted living facility networks with a high risk of SARS-CoV-2 exposure will
      receive LY3819253, LY3819253 and LY3832479, or placebo via an injection into a vein. Samples
      will be taken from the nose. Blood samples will be drawn. Participation could last up to 25
      weeks and may include up to 19 visits.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Percentage of Participants With COVID-19
time frame: Week 8 after randomization
description: The endpoint for the primary analysis is defined as the first occurrence of coronavirus disease - 2019 (COVID-19), defined as the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by reverse transcription - polymerase chain reaction (RT-PCR) AND mild or worse disease severity within 21 days of detection, by Day 57 (8 weeks after randomization). The participant needed to test positive on or prior to week 8, and they needed to develop their symptoms on or after their positive test date, but no later than 21 days after their positive swab OR Week 8, whichever comes first. Logistic regression model was used which includes occurrence of a primary endpoint event as the response variable, and treatment and stratification factors such as facility as explanatory variables.
measure: Percentage of Participants With Moderate or Worse Severity COVID-19
time frame: Week 8 after randomization
description: The endpoint defined as the detection of SARS-CoV-2 by polymerase chain reaction (RT-PCR) AND moderate or worse disease severity within 21 days of detection, by Day 57 (Week 8) were summarized by treatment group. The participant needed to test positive on or prior to week 8, and they needed to develop their symptoms on or after their positive test date, but no later than 21 days after their positive swab OR Week 8, whichever comes first. Logistic regression model was used which includes occurrence of a primary endpoint event as the response variable, and treatment and stratification factors such as facility as explanatory variables.
measure: Percentage of Participants With SARS-CoV-2
time frame: Week 4
description: Percentage of Participants with SARS-CoV-2.
measure: Percentage of Participants Who Are Hospitalized or Have Died Due to COVID-19
time frame: Week 8
description: Percentage of Participants Who are Hospitalized or Have Died due to COVID-19.
measure: Percentage of Participants Who Experience COVID-19-Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death
time frame: Week 8
description: Percentage of Participants who Experience COVID-19-Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death.
measure: Percentage of Participants Who Die Due to COVID-19
time frame: Week 8
description: Percentage of Participants Who Die Due to COVID-19.
measure: Pharmacokinetics (PK): Mean Concentration of Bamlanivimab Administered Alone
time frame: Day 29, 57, 85, 141 and 169
description: Pharmacokinetics (PK): Mean Concentration of bamlanivimab Administered Alone.
arm group label: Bamlanivimab (Part 1)
arm group type: Experimental
description: Participants received single Intravenous (IV) infusion of 4200 milligrams (mg) bamlanivimab.
arm group label: Placebo (Part 1)
arm group type: Placebo Comparator
description: Participants received single IV infusion of Placebo.
arm group label: Bamlanivimab (Part 2-Prevention)
arm group type: Experimental
description: Enrollment for Part 2 was not initiated because the efficacy of Bamlanivimab 4200 mg observed in Part 1 significantly diminished the feasibility of enrolling Part 2.
arm group label: Bamlanivimab + Etesevimab (Part 2-Prevention)
arm group type: Experimental
description: Enrollment for Part 2 was not initiated because the efficacy of Bamlanivimab 4200 mg observed in Part 1 significantly diminished the feasibility of enrolling Part 2.
arm group label: Placebo Comparator: Placebo (Part 2-Prevention)
arm group type: Placebo Comparator
description: Enrollment for Part 2 was not initiated because the efficacy of Bamlanivimab 4200 mg observed in Part 1 significantly diminished the feasibility of enrolling Part 2.
arm group label: Bamlanivimab (Part 2 - Treatment)
arm group type: Experimental
description: Enrollment for Part 2 was not initiated because the efficacy of Bamlanivimab 4200 mg observed in Part 1 significantly diminished the feasibility of enrolling Part 2.
arm group label: Bamlanivimab + Etesevimab (Part 2- Treatment)
arm group type: Experimental
description: Enrollment for Part 2 was not initiated because the efficacy of Bamlanivimab 4200 mg observed in Part 1 significantly diminished the feasibility of enrolling Part 2.
arm group label: Bamlanivimab (Part 3)
arm group type: Experimental
description: Part 3 of the study is exploratory, conducted to study exploratory objectives and is not reported in this record.
[Participants received single IV infusion of 700 mg bamlanivimab.]
arm group label: Bamlanivimab + Etesevimab (Part 3)
arm group type: Experimental
description: Part 3 of the study is exploratory, conducted to study exploratory objectives and is not reported in this record.
[Participants received single IV infusion of 700 mg bamlanivimab given with 1400 mg etesevimab.]
intervention type: Drug
intervention name: Bamlanivimab
description: Administered IV.
arm group label: Bamlanivimab (Part 1)
arm group label: Bamlanivimab (Part 2 - Treatment)
arm group label: Bamlanivimab (Part 2-Prevention)
arm group label: Bamlanivimab (Part 3)
arm group label: Bamlanivimab + Etesevimab (Part 2- Treatment)
arm group label: Bamlanivimab + Etesevimab (Part 2-Prevention)
arm group label: Bamlanivimab + Etesevimab (Part 3)
other name: LY-CoV555
other name: LY3819253
intervention type: Drug
intervention name: Placebo
description: Administered IV.
arm group label: Placebo (Part 1)
arm group label: Placebo Comparator: Placebo (Part 2-Prevention)
intervention type: Drug
intervention name: Etesevimab
description: Administered IV.
arm group label: Bamlanivimab + Etesevimab (Part 2- Treatment)
arm group label: Bamlanivimab + Etesevimab (Part 2-Prevention)
arm group label: Bamlanivimab + Etesevimab (Part 3)
other name: LY-CoV016
other name: LY3832479
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: Study Director
affiliation: Eli Lilly and Company
facility: 
facility: 
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facility: 
country: United States
url: https://trials.lillytrialguide.com/en-US/trial/6hAC2UjP12uxz1fFWVGSKC
description: A Study of LY3819253 (LY-CoV555) to Prevent SARS-CoV-2 Infection and COVID-19 in Nursing Home Residents and Staff (BLAZE-2)
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Bamlanivimab
sharing ipd: Yes
ipd description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
ipd access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
ipd url: https://vivli.org/
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 