<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/NCT02192190</url>
  </required_header>
  <id_info>
    <org_study_id>15515</org_study_id>
    <secondary_id>I5Q-MC-CGAF</secondary_id>
    <nct_id>NCT02192190</nct_id>
  </id_info>
  <brief_title>A Study of LY2951742 in Participants With Mild to Moderate Osteoarthritis Knee Pain</brief_title>
  <official_title>A Phase 2, Randomized, Double-Blind, Placebo and Active-Controlled Trial of LY2951742 in Patients With Mild to Moderate Osteoarthritis Pain of the Knee</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eli Lilly and Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eli Lilly and Company</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main purpose of this study is to test if LY2951742 relieves mild to moderate knee pain.&#xD;
      The study drugs will be given as an injection under the skin and as an oral capsule. The&#xD;
      study will last about 28 weeks for each participant.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Interim assessment: Lack of efficacy&#xD;
  </why_stopped>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline to 8 Weeks in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale</measure>
    <time_frame>Baseline, 8 Weeks</time_frame>
    <description>The 24-question WOMAC Osteoarthritis Index assesses osteoarthritis (OA) symptoms using pain (5 questions), stiffness (2 questions) and physical function (17 questions) subscales. The WOMAC pain subscale was calculated for each participant at each time point for analysis as the mean score (range 0-100 millimeter [mm] VAS; 0=very good and 100=very poor) of all 5 questions related to pain. Bayesian posterior adjusted mean was calculated using a Bayesian Normal Dynamic Linear Model (NDLM) dose response model with baseline and pooled investigator site included as baseline covariates.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to 8 Weeks in the WOMAC Physical Function Subscale</measure>
    <time_frame>Baseline, 8 Weeks</time_frame>
    <description>The 24-question WOMAC Osteoarthritis Index assesses osteoarthritis symptoms using pain (5 questions), stiffness (2 questions) and physical function (17 questions) subscales. The WOMAC Osteoarthritis Index version 3.1 was administered according to the study schedule. The WOMAC physical function subscale was calculated for each participant at each time point for analysis as the mean score (range 0-100 mm VAS; 0=very good and 100=very poor) of all 17 questions related to physical function. Least Square Mean (LSM) was calculated using a mixed-effects model repeated measures (MMRM) approach with treatment, visit and the interaction of treatment and visit were fitted as fixed effects in the model and baseline and pooled investigator site as baseline covariates.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Baseline to 8 Weeks in Patient's Global Assessment of Osteoarthritis</measure>
    <time_frame>Baseline, 8 Weeks</time_frame>
    <description>The PGA is a patient-rated instrument that measures their assessment of overall OA symptoms. It is based on the participant's response to the question &quot;Considering all the ways your osteoarthritis affects you, how are you doing today?&quot; using a 100 mm VAS (0=very good and 100=very poor). LSM mean was calculated using a mixed-effects model repeated measures (MMRM) approach with treatment, visit and the interaction of treatment and visit were fitted as fixed effects in the model and baseline and pooled investigator site as baseline covariates.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With a Response Rate Measured by the Outcome Measures for Rheumatology Committee and Osteoarthritis Research Society International Standing Committee for Clinical Trials Response Criteria Initiative (OMERACT-OARSI)</measure>
    <time_frame>8 Weeks</time_frame>
    <description>The responders according to OMERACT-OARSI criteria: participants with at least 50 % improvement in pain or in function scores, along with absolute improvement of 20 mm, were considered responders. Alternatively, participants were considered responders if they showed at least 20% improvement and absolute improvement of 10 mm in at least two of the following scores: pain, function and Patients Global Assessment (PGA) scores.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to 8 Weeks in the WOMAC Stiffness Subscale</measure>
    <time_frame>Baseline, 8 Weeks</time_frame>
    <description>The 24-question WOMAC Osteoarthritis Index assesses osteoarthritis symptoms using pain (5 questions), stiffness (2 questions) and physical function (17 questions) subscales. The WOMAC stiffness subscale will be calculated for each participant at each time point for analysis as the mean score (range 0-100 mm VAS; 0=very good and 100=very poor) of 2 questions related to stiffness. LSM mean was calculated using a mixed-effects model repeated measures (MMRM) approach with treatment, visit and the interaction of treatment and visit were fitted as fixed effects in the model and baseline and pooled investigator site as baseline covariates. LSM mean was calculated using a mixed-effects model repeated measures (MMRM) approach with treatment, visit and the interaction of treatment and visit were fitted as fixed effects in the model and baseline and pooled investigator site as baseline covariates.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to 8 Weeks in the WOMAC Total Score</measure>
    <time_frame>Baseline, 8 Weeks</time_frame>
    <description>The 24-question WOMAC Osteoarthritis Index assesses osteoarthritis symptoms using pain (5 questions), stiffness (2 questions) and physical function (17 questions) subscales.The WOMAC total score was calculated for each participant at each time point for analysis as the mean score (range 0-100 mm VAS; 0=very good and 100=very poor) of 24 questions. LSM mean was calculated using a mixed-effects model repeated measures (MMRM) approach with treatment, visit and the interaction of treatment and visit were fitted as fixed effects in the model and baseline and pooled investigator site as baseline covariates. LSM mean was calculated using a mixed-effects model repeated measures (MMRM) approach with treatment, visit and the interaction of treatment and visit were fitted as fixed effects in the model and baseline and pooled investigator site as baseline covariates.</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">268</enrollment>
  <condition>Osteoarthritis, Knee</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo capsule orally, once daily for approximately 16 weeks. Placebo subcutaneous (SC) once every 4 weeks for 16 weeks (Treatment period = 16 weeks).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Celecoxib + Placebo</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Celecoxib 200 milligram (mg) capsule orally once daily for approximately 16 weeks. Placebo SC once every 4 weeks for 16 weeks (Treatment period = 16 weeks).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LY2951742 5 mg + Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Placebo capsule orally, once daily for approximately 16 weeks. SC injections of 5 mg LY2951742 once every 4 weeks for 8 weeks followed by placebo SC once every 4 weeks for 8 weeks (Treatment period = 16 weeks).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LY2951742 50 mg + Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Placebo capsule orally, once daily for approximately 16 weeks. SC injections of 50 mg LY2951742 once every 4 weeks for 8 weeks followed by placebo SC once every 4 weeks for 8 weeks (Treatment period = 16 weeks).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LY2951742 120 mg + Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Placebo capsule orally, once daily for approximately 16 weeks. SC injections of 120 mg LY2951742 once every 4 weeks for 8 weeks followed by placebo SC once every 4 weeks for 8 weeks (Treatment period = 16 weeks).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LY2951742 300 mg + Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Placebo capsule orally, once daily for 16 weeks. SC injections of 300 mg LY2951742 once every 4 weeks for 8 weeks followed by placebo SC once every 4 weeks for 8 weeks (Treatment period = 16 weeks).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LY2951742</intervention_name>
    <description>Administered subcutaneously (SC)</description>
    <arm_group_label>LY2951742 120 mg + Placebo</arm_group_label>
    <arm_group_label>LY2951742 300 mg + Placebo</arm_group_label>
    <arm_group_label>LY2951742 5 mg + Placebo</arm_group_label>
    <arm_group_label>LY2951742 50 mg + Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo- oral</intervention_name>
    <description>Administered orally</description>
    <arm_group_label>LY2951742 120 mg + Placebo</arm_group_label>
    <arm_group_label>LY2951742 300 mg + Placebo</arm_group_label>
    <arm_group_label>LY2951742 5 mg + Placebo</arm_group_label>
    <arm_group_label>LY2951742 50 mg + Placebo</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo - SC</intervention_name>
    <description>Administered SC</description>
    <arm_group_label>Celecoxib + Placebo</arm_group_label>
    <arm_group_label>LY2951742 120 mg + Placebo</arm_group_label>
    <arm_group_label>LY2951742 300 mg + Placebo</arm_group_label>
    <arm_group_label>LY2951742 5 mg + Placebo</arm_group_label>
    <arm_group_label>LY2951742 50 mg + Placebo</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Celecoxib</intervention_name>
    <description>Administered orally</description>
    <arm_group_label>Celecoxib + Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have osteoarthritis (OA) of the knee joint based on American College of Rheumatology&#xD;
             (ACR) criteria and confirmed with X-rays and ACR functional class of I to III&#xD;
&#xD;
          -  Have been on stable dose of prescription Nonsteroidal Anti-Inflammatory Drugs&#xD;
             (NSAIDS), celecoxib, tramadol, or acetaminophen of at least 2000 mg per day for at&#xD;
             least 20 days in the past month&#xD;
&#xD;
          -  Willing to stop all analgesics for OA pain during the study&#xD;
&#xD;
          -  Experienced pain while walking in the target knee of 50-90 mm inclusive on 0-100&#xD;
             Visual Analog Scale (VAS) with an increase in pain while walking of at least 10 mm&#xD;
             following washout of current Osteoarthritis pain medications at screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergic to LY2951742, celecoxib, other NSAIDS, including aspirin, and similar drugs&#xD;
&#xD;
          -  Arthritis of the knee from other causes&#xD;
&#xD;
          -  Uncontrolled hypertension&#xD;
&#xD;
          -  Have OA pain that requires treatment with potent opioids, systemic corticosteroids,&#xD;
             intra-articular injections, duloxetine, or venlafaxine&#xD;
&#xD;
          -  Moderate to severe renal impairment&#xD;
&#xD;
          -  Pregnant or lactating&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>75 Years</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>Achieve Clinical Research, LLC</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dream Team Clinical Research</name>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <zip>92801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Artemis Institute for Clinical Research</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Empire Clinical Research</name>
      <address>
        <city>Upland</city>
        <state>California</state>
        <zip>91786</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diablo Clinical Research</name>
      <address>
        <city>Walnut Creek</city>
        <state>California</state>
        <zip>94598</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>iM Research</name>
      <address>
        <city>West Covina</city>
        <state>California</state>
        <zip>91760</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Horizons Clinical Research Center</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80220</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Avail Clinical Research LLC</name>
      <address>
        <city>DeLand</city>
        <state>Florida</state>
        <zip>32720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AGA Clinical Trials</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Palm Springs Research Institute</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Community Research Foundation Inc</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33155</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Institute of South Florida, Inc.</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33173</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>M&amp;M Medical Center</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33185</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Renstar Medical Research</name>
      <address>
        <city>Ocala</city>
        <state>Florida</state>
        <zip>34471</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Compass Research</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>United Osteoporosis Center</name>
      <address>
        <city>Gainesville</city>
        <state>Georgia</state>
        <zip>30501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Drug Studies America</name>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <zip>30060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medex Healthcare Research, Inc.</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60602</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Buynak Clinical Research, P.C.</name>
      <address>
        <city>Valparaiso</city>
        <state>Indiana</state>
        <zip>46383</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beacon Clinical Research, LLC</name>
      <address>
        <city>Brockton</city>
        <state>Massachusetts</state>
        <zip>02301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ActivMed Practices &amp; Research, Inc</name>
      <address>
        <city>Methuen</city>
        <state>Massachusetts</state>
        <zip>01844</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Center for Clinical Trials, Inc.</name>
      <address>
        <city>Biloxi</city>
        <state>Mississippi</state>
        <zip>39531</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arthritis, Rheumatic &amp; Back Disease Associates</name>
      <address>
        <city>Voorhees</city>
        <state>New Jersey</state>
        <zip>08043</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Mexico Clinical Research &amp; Osteoporosis Center</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Drug Trials of America</name>
      <address>
        <city>Hartsdale</city>
        <state>New York</state>
        <zip>10530</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medex Healthcare Research, Inc.</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Upstate Clinical Research Associates</name>
      <address>
        <city>Williamsville</city>
        <state>New York</state>
        <zip>14221</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PharmQuest</name>
      <address>
        <city>Greensboro</city>
        <state>North Carolina</state>
        <zip>27408</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Family Practice Center of Wooster</name>
      <address>
        <city>Wooster</city>
        <state>Ohio</state>
        <zip>44691</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Altoona Center for Clinical Research</name>
      <address>
        <city>Duncansville</city>
        <state>Pennsylvania</state>
        <zip>16635</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Greater Providence Clinical Research, LLC</name>
      <address>
        <city>Warwick</city>
        <state>Rhode Island</state>
        <zip>02888</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trials of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29406</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PCPMG Clinical Research Unit</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Accurate Clinical Research</name>
      <address>
        <city>Nassau Bay</city>
        <state>Texas</state>
        <zip>77058</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Quality Research, Inc.</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Health Research of Hampton Roads Inc</name>
      <address>
        <city>Newport News</city>
        <state>Virginia</state>
        <zip>23606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Clinical Research - Norfolk Inc</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Associates of Tidewater</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23507</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>July 14, 2014</study_first_submitted>
  <study_first_submitted_qc>July 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <results_first_submitted>October 8, 2018</results_first_submitted>
  <results_first_submitted_qc>October 8, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">November 8, 2018</results_first_posted>
  <disposition_first_submitted>September 3, 2015</disposition_first_submitted>
  <disposition_first_submitted_qc>September 3, 2015</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">September 18, 2015</disposition_first_posted>
  <last_update_submitted>August 29, 2019</last_update_submitted>
  <last_update_submitted_qc>August 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Celecoxib</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>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Placebo capsule orally, once daily for 16 weeks. Placebo subcutaneous (SC) once every 4 weeks for 16 weeks.</description>
        </group>
        <group group_id="P2">
          <title>Celecoxib</title>
          <description>Celecoxib 200 milligram (mg) capsule orally once daily for 16 weeks. Placebo SC once every 4 weeks for 16 weeks.</description>
        </group>
        <group group_id="P3">
          <title>LY2951742 5 mg + Placebo</title>
          <description>Placebo capsule orally, once daily for 16 weeks. SC dose of 5 mg LY2951742 once every 4 weeks for 16 weeks.</description>
        </group>
        <group group_id="P4">
          <title>LY2951742 50 mg + Placebo</title>
          <description>Placebo capsule orally, once daily for 16 weeks. SC injection of 50 mg LY2951742 once every 4 weeks for 16 weeks.</description>
        </group>
        <group group_id="P5">
          <title>LY2951742 120 mg + Placebo</title>
          <description>Placebo capsule orally, once daily for 16 weeks. SC injections of 120 mg LY2951742 once every 4 weeks for 16 weeks.</description>
        </group>
        <group group_id="P6">
          <title>LY2951742 300 mg + Placebo</title>
          <description>Placebo capsule orally, once daily for 16 weeks. SC injections of 300 mg LY2951742 once every 4 weeks for 16 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="76"/>
                <participants group_id="P2" count="39"/>
                <participants group_id="P3" count="38"/>
                <participants group_id="P4" count="38"/>
                <participants group_id="P5" count="39"/>
                <participants group_id="P6" count="38"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received at Least 1 Dose of Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="76"/>
                <participants group_id="P2" count="39"/>
                <participants group_id="P3" count="38"/>
                <participants group_id="P4" count="38"/>
                <participants group_id="P5" count="38"/>
                <participants group_id="P6" count="37"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="10"/>
                <participants group_id="P3" count="13"/>
                <participants group_id="P4" count="12"/>
                <participants group_id="P5" count="9"/>
                <participants group_id="P6" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="54"/>
                <participants group_id="P2" count="29"/>
                <participants group_id="P3" count="25"/>
                <participants group_id="P4" count="26"/>
                <participants group_id="P5" count="30"/>
                <participants group_id="P6" count="29"/>
              </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="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="4"/>
                <participants group_id="P6" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Terminated by Sponsor</title>
              <participants_list>
                <participants group_id="P1" count="43"/>
                <participants group_id="P2" count="23"/>
                <participants group_id="P3" count="20"/>
                <participants group_id="P4" count="23"/>
                <participants group_id="P5" count="21"/>
                <participants group_id="P6" count="23"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="5"/>
                <participants group_id="P6" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Could not Keep Visit Schedule</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Positive Drug Screen</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Inadequate Pain Relief</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Randomized participants who received at least 1 dose of study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Placebo capsule orally, once daily for 16 weeks. Placebo subcutaneous (SC) once every 4 weeks for 16 weeks.</description>
        </group>
        <group group_id="B2">
          <title>Celecoxib</title>
          <description>Celecoxib 200 milligram (mg) capsule orally once daily for 16 weeks. Placebo SC once every 4 weeks for 16 weeks.</description>
        </group>
        <group group_id="B3">
          <title>LY2951742 5 mg + Placebo</title>
          <description>Placebo capsule orally, once daily for 16 weeks. SC dose of 5 mg LY2951742 once every 4 weeks for 16 weeks.</description>
        </group>
        <group group_id="B4">
          <title>LY2951742 50 mg + Placebo</title>
          <description>Placebo capsule orally, once daily for 16 weeks. SC injection of 50 mg LY2951742 once every 4 weeks for 16 weeks.</description>
        </group>
        <group group_id="B5">
          <title>LY2951742 120 mg + Placebo</title>
          <description>Placebo capsule orally, once daily for 16 weeks. SC injections of 120 mg LY2951742 once every 4 weeks for 16 weeks.</description>
        </group>
        <group group_id="B6">
          <title>LY2951742 300 mg + Placebo</title>
          <description>Placebo capsule orally, once daily for 16 weeks. SC injections of 300 mg LY2951742 once every 4 weeks for 16 weeks.</description>
        </group>
        <group group_id="B7">
          <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="76"/>
            <count group_id="B2" value="39"/>
            <count group_id="B3" value="38"/>
            <count group_id="B4" value="38"/>
            <count group_id="B5" value="38"/>
            <count group_id="B6" value="37"/>
            <count group_id="B7" value="266"/>
          </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="58.7" spread="7.94"/>
                    <measurement group_id="B2" value="60.8" spread="9.86"/>
                    <measurement group_id="B3" value="58.0" spread="9.60"/>
                    <measurement group_id="B4" value="56.7" spread="7.95"/>
                    <measurement group_id="B5" value="58" spread="9.29"/>
                    <measurement group_id="B6" value="56.4" spread="9.38"/>
                    <measurement group_id="B7" value="58.2" spread="8.91"/>
                  </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="53"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="23"/>
                    <measurement group_id="B4" value="22"/>
                    <measurement group_id="B5" value="23"/>
                    <measurement group_id="B6" value="19"/>
                    <measurement group_id="B7" value="164"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="16"/>
                    <measurement group_id="B5" value="15"/>
                    <measurement group_id="B6" value="18"/>
                    <measurement group_id="B7" value="102"/>
                  </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="42"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="17"/>
                    <measurement group_id="B4" value="19"/>
                    <measurement group_id="B5" value="19"/>
                    <measurement group_id="B6" value="17"/>
                    <measurement group_id="B7" value="135"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="21"/>
                    <measurement group_id="B4" value="19"/>
                    <measurement group_id="B5" value="18"/>
                    <measurement group_id="B6" value="20"/>
                    <measurement group_id="B7" value="130"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" 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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="13"/>
                    <measurement group_id="B5" value="12"/>
                    <measurement group_id="B6" value="13"/>
                    <measurement group_id="B7" value="75"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="54"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="25"/>
                    <measurement group_id="B4" value="25"/>
                    <measurement group_id="B5" value="23"/>
                    <measurement group_id="B6" value="23"/>
                    <measurement group_id="B7" value="181"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline to 8 Weeks in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale</title>
        <description>The 24-question WOMAC Osteoarthritis Index assesses osteoarthritis (OA) symptoms using pain (5 questions), stiffness (2 questions) and physical function (17 questions) subscales. The WOMAC pain subscale was calculated for each participant at each time point for analysis as the mean score (range 0-100 millimeter [mm] VAS; 0=very good and 100=very poor) of all 5 questions related to pain. Bayesian posterior adjusted mean was calculated using a Bayesian Normal Dynamic Linear Model (NDLM) dose response model with baseline and pooled investigator site included as baseline covariates.</description>
        <time_frame>Baseline, 8 Weeks</time_frame>
        <population>Full Analysis Set (FAS) is the number of randomized participants who received at least 1 dose of study drug and had at least 1 post-dose baseline efficacy assessment. N = participants in the full analysis set with an evaluable WOMAC assessment at weeks 2, 4, 6 or 8. The 95% Crl (Credible Interval) is reported, not confidence interval (CI).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo capsule orally, once daily for 16 weeks. Placebo subcutaneous (SC) once every 4 weeks for 16 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Celecoxib</title>
            <description>Celecoxib 200 milligram (mg) capsule orally once daily for 16 weeks. Placebo SC once every 4 weeks for 16 weeks.</description>
          </group>
          <group group_id="O3">
            <title>LY2951742 5 mg + Placebo</title>
            <description>Placebo capsule orally, once daily for 16 weeks. SC dose of 5 mg LY2951742 once every 4 weeks for 16 weeks.</description>
          </group>
          <group group_id="O4">
            <title>LY2951742 50 mg + Placebo</title>
            <description>Placebo capsule orally, once daily for 16 weeks. SC injection of 50 mg LY2951742 once every 4 weeks for 16 weeks.</description>
          </group>
          <group group_id="O5">
            <title>LY2951742 120 mg + Placebo</title>
            <description>Placebo capsule orally, once daily for 16 weeks. SC injections of 120 mg LY2951742 once every 4 weeks for 16 weeks.</description>
          </group>
          <group group_id="O6">
            <title>LY2951742 300 mg + Placebo</title>
            <description>Placebo capsule orally, once daily for 16 weeks. SC injections of 300 mg LY2951742 once every 4 weeks for 16 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to 8 Weeks in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale</title>
          <description>The 24-question WOMAC Osteoarthritis Index assesses osteoarthritis (OA) symptoms using pain (5 questions), stiffness (2 questions) and physical function (17 questions) subscales. The WOMAC pain subscale was calculated for each participant at each time point for analysis as the mean score (range 0-100 millimeter [mm] VAS; 0=very good and 100=very poor) of all 5 questions related to pain. Bayesian posterior adjusted mean was calculated using a Bayesian Normal Dynamic Linear Model (NDLM) dose response model with baseline and pooled investigator site included as baseline covariates.</description>
          <population>Full Analysis Set (FAS) is the number of randomized participants who received at least 1 dose of study drug and had at least 1 post-dose baseline efficacy assessment. N = participants in the full analysis set with an evaluable WOMAC assessment at weeks 2, 4, 6 or 8. The 95% Crl (Credible Interval) is reported, not confidence interval (CI).</population>
          <units>mm</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="65"/>
                <count group_id="O2" value="32"/>
                <count group_id="O3" value="31"/>
                <count group_id="O4" value="31"/>
                <count group_id="O5" value="30"/>
                <count group_id="O6" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-19.2" lower_limit="-24.7" upper_limit="-13.4"/>
                    <measurement group_id="O2" value="-31.3" lower_limit="-40.1" upper_limit="-22.5"/>
                    <measurement group_id="O3" value="-16.4" lower_limit="-23.9" upper_limit="-8.6"/>
                    <measurement group_id="O4" value="-24.2" lower_limit="-31.0" upper_limit="-17.2"/>
                    <measurement group_id="O5" value="-21.8" lower_limit="-29.3" upper_limit="-14.2"/>
                    <measurement group_id="O6" value="-17.7" lower_limit="-25.2" upper_limit="-10.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to 8 Weeks in the WOMAC Physical Function Subscale</title>
        <description>The 24-question WOMAC Osteoarthritis Index assesses osteoarthritis symptoms using pain (5 questions), stiffness (2 questions) and physical function (17 questions) subscales. The WOMAC Osteoarthritis Index version 3.1 was administered according to the study schedule. The WOMAC physical function subscale was calculated for each participant at each time point for analysis as the mean score (range 0-100 mm VAS; 0=very good and 100=very poor) of all 17 questions related to physical function. Least Square Mean (LSM) was calculated using a mixed-effects model repeated measures (MMRM) approach with treatment, visit and the interaction of treatment and visit were fitted as fixed effects in the model and baseline and pooled investigator site as baseline covariates.</description>
        <time_frame>Baseline, 8 Weeks</time_frame>
        <population>FAS: Randomized participants who received at least 1 dose of study drug and had at least 1 post-dose baseline efficacy assessment. N = participants in the full analysis set with an evaluable WOMAC assessment at weeks 2, 4, 6 or 8.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo capsule orally, once daily for 16 weeks. Placebo subcutaneous (SC) once every 4 weeks for 16 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Celecoxib</title>
            <description>Celecoxib 200 milligram (mg) capsule orally once daily for 16 weeks. Placebo SC once every 4 weeks for 16 weeks.</description>
          </group>
          <group group_id="O3">
            <title>LY2951742 5 mg + Placebo</title>
            <description>Placebo capsule orally, once daily for 16 weeks. SC dose of 5 mg LY2951742 once every 4 weeks for 16 weeks.</description>
          </group>
          <group group_id="O4">
            <title>LY2951742 50 mg + Placebo</title>
            <description>Placebo capsule orally, once daily for 16 weeks. SC injection of 50 mg LY2951742 once every 4 weeks for 16 weeks.</description>
          </group>
          <group group_id="O5">
            <title>LY2951742 120 mg + Placebo</title>
            <description>Placebo capsule orally, once daily for 16 weeks. SC injections of 120 mg LY2951742 once every 4 weeks for 16 weeks.</description>
          </group>
          <group group_id="O6">
            <title>LY2951742 300 mg + Placebo</title>
            <description>Placebo capsule orally, once daily for 16 weeks. SC injections of 300 mg LY2951742 once every 4 weeks for 16 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to 8 Weeks in the WOMAC Physical Function Subscale</title>
          <description>The 24-question WOMAC Osteoarthritis Index assesses osteoarthritis symptoms using pain (5 questions), stiffness (2 questions) and physical function (17 questions) subscales. The WOMAC Osteoarthritis Index version 3.1 was administered according to the study schedule. The WOMAC physical function subscale was calculated for each participant at each time point for analysis as the mean score (range 0-100 mm VAS; 0=very good and 100=very poor) of all 17 questions related to physical function. Least Square Mean (LSM) was calculated using a mixed-effects model repeated measures (MMRM) approach with treatment, visit and the interaction of treatment and visit were fitted as fixed effects in the model and baseline and pooled investigator site as baseline covariates.</description>
          <population>FAS: Randomized participants who received at least 1 dose of study drug and had at least 1 post-dose baseline efficacy assessment. N = participants in the full analysis set with an evaluable WOMAC assessment at weeks 2, 4, 6 or 8.</population>
          <units>mm</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="65"/>
                <count group_id="O2" value="32"/>
                <count group_id="O3" value="31"/>
                <count group_id="O4" value="31"/>
                <count group_id="O5" value="30"/>
                <count group_id="O6" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-16.5" lower_limit="-22.3" upper_limit="-10.8"/>
                    <measurement group_id="O2" value="-30.6" lower_limit="-38.8" upper_limit="-22.4"/>
                    <measurement group_id="O3" value="-15.4" lower_limit="-23.7" upper_limit="-7.12"/>
                    <measurement group_id="O4" value="-23.5" lower_limit="-31.4" upper_limit="-15.6"/>
                    <measurement group_id="O5" value="-19.5" lower_limit="-28.2" upper_limit="-10.9"/>
                    <measurement group_id="O6" value="-18.4" lower_limit="-26.8" upper_limit="-9.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Baseline to 8 Weeks in Patient's Global Assessment of Osteoarthritis</title>
        <description>The PGA is a patient-rated instrument that measures their assessment of overall OA symptoms. It is based on the participant's response to the question &quot;Considering all the ways your osteoarthritis affects you, how are you doing today?&quot; using a 100 mm VAS (0=very good and 100=very poor). LSM mean was calculated using a mixed-effects model repeated measures (MMRM) approach with treatment, visit and the interaction of treatment and visit were fitted as fixed effects in the model and baseline and pooled investigator site as baseline covariates.</description>
        <time_frame>Baseline, 8 Weeks</time_frame>
        <population>FAS: Randomized participants who received at least 1 dose of study drug and had at least 1 post-dose baseline efficacy assessment. N = participants in the full analysis set with an evaluable PGA assessment at weeks 2, 4, 6 or 8.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo capsule orally, once daily for 16 weeks. Placebo subcutaneous (SC) once every 4 weeks for 16 weeks</description>
          </group>
          <group group_id="O2">
            <title>Celecoxib</title>
            <description>Celecoxib 200 milligram (mg) capsule orally once daily for 16 weeks. Placebo SC once every 4 weeks for 16 weeks.</description>
          </group>
          <group group_id="O3">
            <title>LY2951742 5 mg + Placebo</title>
            <description>Placebo capsule orally, once daily for 16 weeks. SC dose of 5 mg LY2951742 once every 4 weeks for 16 weeks.</description>
          </group>
          <group group_id="O4">
            <title>LY2951742 50 mg + Placebo</title>
            <description>Placebo capsule orally, once daily for 16 weeks. SC injection of 50 mg LY2951742 once every 4 weeks for 16 weeks.</description>
          </group>
          <group group_id="O5">
            <title>LY2951742 120 mg + Placebo</title>
            <description>Placebo capsule orally, once daily for 16 weeks. SC injections of 120 mg LY2951742 once every 4 weeks for 16 weeks.</description>
          </group>
          <group group_id="O6">
            <title>LY2951742 300 mg + Placebo</title>
            <description>Placebo capsule orally, once daily for 16 weeks. SC injections of 300 mg LY2951742 once every 4 weeks for 16 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Baseline to 8 Weeks in Patient's Global Assessment of Osteoarthritis</title>
          <description>The PGA is a patient-rated instrument that measures their assessment of overall OA symptoms. It is based on the participant's response to the question &quot;Considering all the ways your osteoarthritis affects you, how are you doing today?&quot; using a 100 mm VAS (0=very good and 100=very poor). LSM mean was calculated using a mixed-effects model repeated measures (MMRM) approach with treatment, visit and the interaction of treatment and visit were fitted as fixed effects in the model and baseline and pooled investigator site as baseline covariates.</description>
          <population>FAS: Randomized participants who received at least 1 dose of study drug and had at least 1 post-dose baseline efficacy assessment. N = participants in the full analysis set with an evaluable PGA assessment at weeks 2, 4, 6 or 8.</population>
          <units>mm</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="31"/>
                <count group_id="O3" value="29"/>
                <count group_id="O4" value="30"/>
                <count group_id="O5" value="28"/>
                <count group_id="O6" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-22.5" lower_limit="-28.8" upper_limit="-16.2"/>
                    <measurement group_id="O2" value="-36.7" lower_limit="-45.7" upper_limit="-27.6"/>
                    <measurement group_id="O3" value="-18.5" lower_limit="-27.9" upper_limit="-9.1"/>
                    <measurement group_id="O4" value="-19.4" lower_limit="-28.0" upper_limit="-10.8"/>
                    <measurement group_id="O5" value="-21.2" lower_limit="-31.2" upper_limit="-11.1"/>
                    <measurement group_id="O6" value="-20.4" lower_limit="-30.0" upper_limit="-10.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With a Response Rate Measured by the Outcome Measures for Rheumatology Committee and Osteoarthritis Research Society International Standing Committee for Clinical Trials Response Criteria Initiative (OMERACT-OARSI)</title>
        <description>The responders according to OMERACT-OARSI criteria: participants with at least 50 % improvement in pain or in function scores, along with absolute improvement of 20 mm, were considered responders. Alternatively, participants were considered responders if they showed at least 20% improvement and absolute improvement of 10 mm in at least two of the following scores: pain, function and Patients Global Assessment (PGA) scores.</description>
        <time_frame>8 Weeks</time_frame>
        <population>FAS: Randomized participants who received at least 1 dose of study drug and had at least one post-dose efficacy assessment. N= participants analyzed in the full analysis set with an evaluable response rate at week 8.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo capsule orally, once daily for 16 weeks. Placebo subcutaneous (SC) once every 4 weeks for 16 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Celecoxib</title>
            <description>Celecoxib 200 milligram (mg) capsule orally once daily for 16 weeks. Placebo SC once every 4 weeks for 16 weeks.</description>
          </group>
          <group group_id="O3">
            <title>LY2951742 5 mg + Placebo</title>
            <description>Placebo capsule orally, once daily for 16 weeks. SC dose of 5 mg LY2951742 once every 4 weeks for 16 weeks.</description>
          </group>
          <group group_id="O4">
            <title>LY2951742 50 mg + Placebo</title>
            <description>Placebo capsule orally, once daily for 16 weeks. SC injection of 50 mg LY2951742 once every 4 weeks for 16 weeks.</description>
          </group>
          <group group_id="O5">
            <title>LY2951742 120 mg + Placebo</title>
            <description>Placebo capsule orally, once daily for 16 weeks. SC injections of 120 mg LY2951742 once every 4 weeks for 16 weeks.</description>
          </group>
          <group group_id="O6">
            <title>LY2951742 300 mg + Placebo</title>
            <description>Placebo capsule orally, once daily for 16 weeks. SC injections of 300 mg LY2951742 once every 4 weeks for 16 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With a Response Rate Measured by the Outcome Measures for Rheumatology Committee and Osteoarthritis Research Society International Standing Committee for Clinical Trials Response Criteria Initiative (OMERACT-OARSI)</title>
          <description>The responders according to OMERACT-OARSI criteria: participants with at least 50 % improvement in pain or in function scores, along with absolute improvement of 20 mm, were considered responders. Alternatively, participants were considered responders if they showed at least 20% improvement and absolute improvement of 10 mm in at least two of the following scores: pain, function and Patients Global Assessment (PGA) scores.</description>
          <population>FAS: Randomized participants who received at least 1 dose of study drug and had at least one post-dose efficacy assessment. N= participants analyzed in the full analysis set with an evaluable response rate at week 8.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="29"/>
                <count group_id="O4" value="22"/>
                <count group_id="O5" value="16"/>
                <count group_id="O6" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="14"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="15"/>
                    <measurement group_id="O5" value="10"/>
                    <measurement group_id="O6" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to 8 Weeks in the WOMAC Stiffness Subscale</title>
        <description>The 24-question WOMAC Osteoarthritis Index assesses osteoarthritis symptoms using pain (5 questions), stiffness (2 questions) and physical function (17 questions) subscales. The WOMAC stiffness subscale will be calculated for each participant at each time point for analysis as the mean score (range 0-100 mm VAS; 0=very good and 100=very poor) of 2 questions related to stiffness. LSM mean was calculated using a mixed-effects model repeated measures (MMRM) approach with treatment, visit and the interaction of treatment and visit were fitted as fixed effects in the model and baseline and pooled investigator site as baseline covariates. LSM mean was calculated using a mixed-effects model repeated measures (MMRM) approach with treatment, visit and the interaction of treatment and visit were fitted as fixed effects in the model and baseline and pooled investigator site as baseline covariates.</description>
        <time_frame>Baseline, 8 Weeks</time_frame>
        <population>FAS: Randomized participants who received at least 1 dose of study drug and had at least 1 post-dose baseline efficacy assessment. N = participants in the full analysis set with an evaluable WOMAC assessment at weeks 2, 4, 6 or 8.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo capsule orally, once daily for 16 weeks. Placebo subcutaneous (SC) once every 4 weeks for 16 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Celecoxib</title>
            <description>Celecoxib 200 milligram (mg) capsule orally once daily for 16 weeks. Placebo SC once every 4 weeks for 16 weeks.</description>
          </group>
          <group group_id="O3">
            <title>LY2951742 5 mg + Placebo</title>
            <description>Placebo capsule orally, once daily for 16 weeks. SC dose of 5 mg LY2951742 once every 4 weeks for 16 weeks.</description>
          </group>
          <group group_id="O4">
            <title>LY2951742 50 mg + Placebo</title>
            <description>Placebo capsule orally, once daily for 16 weeks. SC injection of 50 mg LY2951742 once every 4 weeks for 16 weeks.</description>
          </group>
          <group group_id="O5">
            <title>LY2951742 120 mg + Placebo</title>
            <description>Placebo capsule orally, once daily for 16 weeks. SC injections of 120 mg LY2951742 once every 4 weeks for 16 weeks.</description>
          </group>
          <group group_id="O6">
            <title>LY2951742 300 mg + Placebo</title>
            <description>Placebo capsule orally, once daily for 16 weeks. SC injections of 300 mg LY2951742 once every 4 weeks for 16 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to 8 Weeks in the WOMAC Stiffness Subscale</title>
          <description>The 24-question WOMAC Osteoarthritis Index assesses osteoarthritis symptoms using pain (5 questions), stiffness (2 questions) and physical function (17 questions) subscales. The WOMAC stiffness subscale will be calculated for each participant at each time point for analysis as the mean score (range 0-100 mm VAS; 0=very good and 100=very poor) of 2 questions related to stiffness. LSM mean was calculated using a mixed-effects model repeated measures (MMRM) approach with treatment, visit and the interaction of treatment and visit were fitted as fixed effects in the model and baseline and pooled investigator site as baseline covariates. LSM mean was calculated using a mixed-effects model repeated measures (MMRM) approach with treatment, visit and the interaction of treatment and visit were fitted as fixed effects in the model and baseline and pooled investigator site as baseline covariates.</description>
          <population>FAS: Randomized participants who received at least 1 dose of study drug and had at least 1 post-dose baseline efficacy assessment. N = participants in the full analysis set with an evaluable WOMAC assessment at weeks 2, 4, 6 or 8.</population>
          <units>mm</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="65"/>
                <count group_id="O2" value="32"/>
                <count group_id="O3" value="31"/>
                <count group_id="O4" value="31"/>
                <count group_id="O5" value="30"/>
                <count group_id="O6" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-18.5" lower_limit="-24.6" upper_limit="-12.4"/>
                    <measurement group_id="O2" value="-31.4" lower_limit="-40.1" upper_limit="-22.7"/>
                    <measurement group_id="O3" value="-15.1" lower_limit="-24.0" upper_limit="-6.3"/>
                    <measurement group_id="O4" value="-23.7" lower_limit="-32.1" upper_limit="-15.4"/>
                    <measurement group_id="O5" value="-21.3" lower_limit="-30.7" upper_limit="-12.0"/>
                    <measurement group_id="O6" value="-17.3" lower_limit="-26.2" upper_limit="-8.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to 8 Weeks in the WOMAC Total Score</title>
        <description>The 24-question WOMAC Osteoarthritis Index assesses osteoarthritis symptoms using pain (5 questions), stiffness (2 questions) and physical function (17 questions) subscales.The WOMAC total score was calculated for each participant at each time point for analysis as the mean score (range 0-100 mm VAS; 0=very good and 100=very poor) of 24 questions. LSM mean was calculated using a mixed-effects model repeated measures (MMRM) approach with treatment, visit and the interaction of treatment and visit were fitted as fixed effects in the model and baseline and pooled investigator site as baseline covariates. LSM mean was calculated using a mixed-effects model repeated measures (MMRM) approach with treatment, visit and the interaction of treatment and visit were fitted as fixed effects in the model and baseline and pooled investigator site as baseline covariates.</description>
        <time_frame>Baseline, 8 Weeks</time_frame>
        <population>FAS: Randomized participants who received at least 1 dose of study drug and had at least 1 post-dose baseline efficacy assessment. N = participants in the full analysis set with an evaluable WOMAC assessment at weeks 2, 4, 6 or 8.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo capsule orally, once daily for 16 weeks. Placebo subcutaneous (SC) once every 4 weeks for 16 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Celecoxib</title>
            <description>Celecoxib 200 milligram (mg) capsule orally once daily for 16 weeks. Placebo SC once every 4 weeks for 16 weeks.</description>
          </group>
          <group group_id="O3">
            <title>LY2951742 5 mg + Placebo</title>
            <description>Placebo capsule orally, once daily for 16 weeks. SC dose of 5 mg LY2951742 once every 4 weeks for 16 weeks.</description>
          </group>
          <group group_id="O4">
            <title>LY2951742 50 mg + Placebo</title>
            <description>Placebo capsule orally, once daily for 16 weeks. SC injection of 50 mg LY2951742 once every 4 weeks for 16 weeks.</description>
          </group>
          <group group_id="O5">
            <title>LY2951742 120 mg + Placebo</title>
            <description>Placebo capsule orally, once daily for 16 weeks. SC injections of 120 mg LY2951742 once every 4 weeks for 16 weeks.</description>
          </group>
          <group group_id="O6">
            <title>LY2951742 300 mg + Placebo</title>
            <description>Placebo capsule orally, once daily for 16 weeks. SC injections of 300 mg LY2951742 once every 4 weeks for 16 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to 8 Weeks in the WOMAC Total Score</title>
          <description>The 24-question WOMAC Osteoarthritis Index assesses osteoarthritis symptoms using pain (5 questions), stiffness (2 questions) and physical function (17 questions) subscales.The WOMAC total score was calculated for each participant at each time point for analysis as the mean score (range 0-100 mm VAS; 0=very good and 100=very poor) of 24 questions. LSM mean was calculated using a mixed-effects model repeated measures (MMRM) approach with treatment, visit and the interaction of treatment and visit were fitted as fixed effects in the model and baseline and pooled investigator site as baseline covariates. LSM mean was calculated using a mixed-effects model repeated measures (MMRM) approach with treatment, visit and the interaction of treatment and visit were fitted as fixed effects in the model and baseline and pooled investigator site as baseline covariates.</description>
          <population>FAS: Randomized participants who received at least 1 dose of study drug and had at least 1 post-dose baseline efficacy assessment. N = participants in the full analysis set with an evaluable WOMAC assessment at weeks 2, 4, 6 or 8.</population>
          <units>mm</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="65"/>
                <count group_id="O2" value="32"/>
                <count group_id="O3" value="31"/>
                <count group_id="O4" value="31"/>
                <count group_id="O5" value="30"/>
                <count group_id="O6" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-17.0" lower_limit="-22.7" upper_limit="-11.4"/>
                    <measurement group_id="O2" value="-31.1" lower_limit="-39.2" upper_limit="-23.0"/>
                    <measurement group_id="O3" value="-15.6" lower_limit="-23.8" upper_limit="-7.47"/>
                    <measurement group_id="O4" value="-23.7" lower_limit="-31.5" upper_limit="-15.9"/>
                    <measurement group_id="O5" value="-20.0" lower_limit="-28.5" upper_limit="-11.5"/>
                    <measurement group_id="O6" value="-18.4" lower_limit="-26.7" upper_limit="-10.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>All randomized participants who received at least 1 dose of study drug.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Placebo capsule orally, once daily for 16 weeks. Placebo subcutaneous (SC) once every 4 weeks for 16 weeks.</description>
        </group>
        <group group_id="E2">
          <title>Celecoxib</title>
          <description>Celecoxib 200 milligram (mg) capsule orally once daily for 16 weeks. Placebo SC once every 4 weeks for 16 weeks.</description>
        </group>
        <group group_id="E3">
          <title>LY2951742 5 mg + Placebo</title>
          <description>Placebo capsule orally, once daily for 16 weeks. SC dose of 5 mg LY2951742 once every 4 weeks for 16 weeks.</description>
        </group>
        <group group_id="E4">
          <title>LY2951742 50 mg + Placebo</title>
          <description>Placebo capsule orally, once daily for 16 weeks. SC injection of 50 mg LY2951742 once every 4 weeks for 16 weeks.</description>
        </group>
        <group group_id="E5">
          <title>LY2951742 120 mg + Placebo</title>
          <description>Placebo capsule orally, once daily for 16 weeks. SC injections of 120 mg LY2951742 once every 4 weeks for 16 weeks.</description>
        </group>
        <group group_id="E6">
          <title>LY2951742 300 mg + Placebo</title>
          <description>Placebo capsule orally, once daily for 16 weeks. SC injections of 300 mg LY2951742 once every 4 weeks for 16 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 17.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="37"/>
              </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="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Catheter site infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 17.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="27" subjects_at_risk="76"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="39"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="38"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="38"/>
                <counts group_id="E5" subjects_affected="13" subjects_at_risk="38"/>
                <counts group_id="E6" subjects_affected="9" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Atrioventricular block</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Left ventricular hypertrophy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </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="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Food poisoning</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Large intestine polyp</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Injection site reaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Local swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Nodule</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Drug hypersensitivity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Food allergy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Seasonal allergy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Ear infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="38"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="76"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Oral herpes</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Otitis externa</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Otitis media</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Pharyngitis streptococcal</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Tonsillitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Tooth infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Arthropod bite</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Joint injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Limb injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Tooth fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood creatine phosphokinase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Blood glucose increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Computerised tomogram abnormal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Electrocardiogram qt prolonged</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Glomerular filtration rate decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hepatic enzyme increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypercholesterolaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Type 2 diabetes mellitus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </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="1" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="76"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" events="2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Bursitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="76"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="39"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Rotator cuff syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Synovial cyst</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Benign breast neoplasm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Burning sensation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Convulsion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="5" subjects_affected="2" subjects_at_risk="76"/>
                <counts group_id="E2" events="3" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E5" events="3" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depressed mood</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Seasonal affective disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Polyuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Respiratory tract congestion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract congestion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Tooth extraction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Peripheral arterial occlusive disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" events="2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </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>
    </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/NCT02192190
org study id: 15515
secondary id: I5Q-MC-CGAF
nct id: NCT02192190
lead sponsor: 
has dmc: Yes
The main purpose of this study is to test if LY2951742 relieves mild to moderate knee pain.
      The study drugs will be given as an injection under the skin and as an oral capsule. The
      study will last about 28 weeks for each participant.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change From Baseline to 8 Weeks in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale
time frame: Baseline, 8 Weeks
description: The 24-question WOMAC Osteoarthritis Index assesses osteoarthritis (OA) symptoms using pain (5 questions), stiffness (2 questions) and physical function (17 questions) subscales. The WOMAC pain subscale was calculated for each participant at each time point for analysis as the mean score (range 0-100 millimeter [mm] VAS; 0=very good and 100=very poor) of all 5 questions related to pain. Bayesian posterior adjusted mean was calculated using a Bayesian Normal Dynamic Linear Model (NDLM) dose response model with baseline and pooled investigator site included as baseline covariates.
measure: Change From Baseline to 8 Weeks in the WOMAC Physical Function Subscale
time frame: Baseline, 8 Weeks
description: The 24-question WOMAC Osteoarthritis Index assesses osteoarthritis symptoms using pain (5 questions), stiffness (2 questions) and physical function (17 questions) subscales. The WOMAC Osteoarthritis Index version 3.1 was administered according to the study schedule. The WOMAC physical function subscale was calculated for each participant at each time point for analysis as the mean score (range 0-100 mm VAS; 0=very good and 100=very poor) of all 17 questions related to physical function. Least Square Mean (LSM) was calculated using a mixed-effects model repeated measures (MMRM) approach with treatment, visit and the interaction of treatment and visit were fitted as fixed effects in the model and baseline and pooled investigator site as baseline covariates.
measure: Change in Baseline to 8 Weeks in Patient's Global Assessment of Osteoarthritis
time frame: Baseline, 8 Weeks
description: The PGA is a patient-rated instrument that measures their assessment of overall OA symptoms. It is based on the participant's response to the question "Considering all the ways your osteoarthritis affects you, how are you doing today?" using a 100 mm VAS (0=very good and 100=very poor). LSM mean was calculated using a mixed-effects model repeated measures (MMRM) approach with treatment, visit and the interaction of treatment and visit were fitted as fixed effects in the model and baseline and pooled investigator site as baseline covariates.
measure: Number of Participants With a Response Rate Measured by the Outcome Measures for Rheumatology Committee and Osteoarthritis Research Society International Standing Committee for Clinical Trials Response Criteria Initiative (OMERACT-OARSI)
time frame: 8 Weeks
description: The responders according to OMERACT-OARSI criteria: participants with at least 50 % improvement in pain or in function scores, along with absolute improvement of 20 mm, were considered responders. Alternatively, participants were considered responders if they showed at least 20% improvement and absolute improvement of 10 mm in at least two of the following scores: pain, function and Patients Global Assessment (PGA) scores.
measure: Change From Baseline to 8 Weeks in the WOMAC Stiffness Subscale
time frame: Baseline, 8 Weeks
description: The 24-question WOMAC Osteoarthritis Index assesses osteoarthritis symptoms using pain (5 questions), stiffness (2 questions) and physical function (17 questions) subscales. The WOMAC stiffness subscale will be calculated for each participant at each time point for analysis as the mean score (range 0-100 mm VAS; 0=very good and 100=very poor) of 2 questions related to stiffness. LSM mean was calculated using a mixed-effects model repeated measures (MMRM) approach with treatment, visit and the interaction of treatment and visit were fitted as fixed effects in the model and baseline and pooled investigator site as baseline covariates. LSM mean was calculated using a mixed-effects model repeated measures (MMRM) approach with treatment, visit and the interaction of treatment and visit were fitted as fixed effects in the model and baseline and pooled investigator site as baseline covariates.
measure: Change From Baseline to 8 Weeks in the WOMAC Total Score
time frame: Baseline, 8 Weeks
description: The 24-question WOMAC Osteoarthritis Index assesses osteoarthritis symptoms using pain (5 questions), stiffness (2 questions) and physical function (17 questions) subscales.The WOMAC total score was calculated for each participant at each time point for analysis as the mean score (range 0-100 mm VAS; 0=very good and 100=very poor) of 24 questions. LSM mean was calculated using a mixed-effects model repeated measures (MMRM) approach with treatment, visit and the interaction of treatment and visit were fitted as fixed effects in the model and baseline and pooled investigator site as baseline covariates. LSM mean was calculated using a mixed-effects model repeated measures (MMRM) approach with treatment, visit and the interaction of treatment and visit were fitted as fixed effects in the model and baseline and pooled investigator site as baseline covariates.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo capsule orally, once daily for approximately 16 weeks. Placebo subcutaneous (SC) once every 4 weeks for 16 weeks (Treatment period = 16 weeks).
arm group label: Celecoxib + Placebo
arm group type: Active Comparator
description: Celecoxib 200 milligram (mg) capsule orally once daily for approximately 16 weeks. Placebo SC once every 4 weeks for 16 weeks (Treatment period = 16 weeks).
arm group label: LY2951742 5 mg + Placebo
arm group type: Experimental
description: Placebo capsule orally, once daily for approximately 16 weeks. SC injections of 5 mg LY2951742 once every 4 weeks for 8 weeks followed by placebo SC once every 4 weeks for 8 weeks (Treatment period = 16 weeks).
arm group label: LY2951742 50 mg + Placebo
arm group type: Experimental
description: Placebo capsule orally, once daily for approximately 16 weeks. SC injections of 50 mg LY2951742 once every 4 weeks for 8 weeks followed by placebo SC once every 4 weeks for 8 weeks (Treatment period = 16 weeks).
arm group label: LY2951742 120 mg + Placebo
arm group type: Experimental
description: Placebo capsule orally, once daily for approximately 16 weeks. SC injections of 120 mg LY2951742 once every 4 weeks for 8 weeks followed by placebo SC once every 4 weeks for 8 weeks (Treatment period = 16 weeks).
arm group label: LY2951742 300 mg + Placebo
arm group type: Experimental
description: Placebo capsule orally, once daily for 16 weeks. SC injections of 300 mg LY2951742 once every 4 weeks for 8 weeks followed by placebo SC once every 4 weeks for 8 weeks (Treatment period = 16 weeks).
intervention type: Drug
intervention name: LY2951742
description: Administered subcutaneously (SC)
arm group label: LY2951742 120 mg + Placebo
arm group label: LY2951742 300 mg + Placebo
arm group label: LY2951742 5 mg + Placebo
arm group label: LY2951742 50 mg + Placebo
intervention type: Other
intervention name: Placebo- oral
description: Administered orally
arm group label: LY2951742 120 mg + Placebo
arm group label: LY2951742 300 mg + Placebo
arm group label: LY2951742 5 mg + Placebo
arm group label: LY2951742 50 mg + Placebo
arm group label: Placebo
intervention type: Other
intervention name: Placebo - SC
description: Administered SC
arm group label: Celecoxib + Placebo
arm group label: LY2951742 120 mg + Placebo
arm group label: LY2951742 300 mg + Placebo
arm group label: LY2951742 5 mg + Placebo
arm group label: LY2951742 50 mg + Placebo
arm group label: Placebo
intervention type: Drug
intervention name: Celecoxib
description: Administered orally
arm group label: Celecoxib + Placebo
criteria: 
gender: All
minimum age: 40 Years
maximum age: 75 Years
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
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country: United States
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
mesh term: Celecoxib
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/
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 