<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/NCT03241342</url>
  </required_header>
  <id_info>
    <org_study_id>G201002</org_study_id>
    <nct_id>NCT03241342</nct_id>
  </id_info>
  <brief_title>Study to Assess Enobosarm (GTx-024) in Postmenopausal Women With Stress Urinary Incontinence</brief_title>
  <acronym>ASTRID</acronym>
  <official_title>Double-Blind, Placebo-Controlled, Parallel Design, Phase 2 Study to Assess Clinical Activity and Safety of Enobosarm (GTx-024) in Postmenopausal Women With Stress Urinary Incontinence</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GTx</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GTx</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      GTx-024 is an orally bioavailable and tissue-selective nonsteroidal selective androgen&#xD;
      receptor modulator (SARM) that has demonstrated androgenic and anabolic activity and is&#xD;
      currently being evaluated as a potential treatment for stress urinary incontinence (SUI) in&#xD;
      postmenopausal women. Urinary incontinence and pelvic floor disorders are major health&#xD;
      problems for women, especially as they age. Pelvic floor muscle relaxation has been found to&#xD;
      correlate with lower urinary tract symptoms including SUI. Muscles of the pelvic floor and&#xD;
      lower urinary tract are crucial for supporting the pelvic organs and micturition; however,&#xD;
      damage to the muscles or lack of hormonal stimulation are thought to contribute to pelvic&#xD;
      organ prolapse and urinary incontinence. Although anabolic steroids may increase muscle mass&#xD;
      and strength, lack of oral bioavailability and known potential risks have limited their use.&#xD;
      Nonsteroidal SARMs have potential to achieve benefits of anabolic steroid therapy (improved&#xD;
      muscle mass, cholesterol/triglyceride levels, glucose metabolism, and bone density) with&#xD;
      fewer adverse effects, such as hirsutism and acne, in women. Both nonclinical and clinical&#xD;
      data suggest that SARMs may provide a new therapeutic option for pelvic floor and lower&#xD;
      urinary tract disorders, as both testosterone and its more potent metabolite,&#xD;
      dihydrotestosterone, have anabolic effects on muscle.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 21, 2017</start_date>
  <completion_date type="Actual">September 21, 2018</completion_date>
  <primary_completion_date type="Actual">September 21, 2018</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>
    <intervention_model_description>Double-blind, placebo-controlled, parallel design, randomized, multicenter, Phase 2 study consisting of the following periods: screening period, treatment period, and follow-up period.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With a ≥ 50% Reduction From Baseline in the Mean Number of Stress Incontinence Episodes Per Day at Week 12</measure>
    <time_frame>12 Weeks</time_frame>
    <description>Mean number of subject-reported stress incontinence episodes per day through a responder analysis, where a responder is defined as having a ≥ 50% reduction at the end of treatment (Week 12) compared to baseline in the number of stress incontinence episodes</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">491</enrollment>
  <condition>Stress Urinary Incontinence</condition>
  <arm_group>
    <arm_group_label>1 mg GTx-024</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3 mg GTx-024</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>matching placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GTx 024</intervention_name>
    <description>Study drug is an opaque, white to off-white, size 5, oval Softgel capsule containing the active ingredient GTx-024.</description>
    <arm_group_label>1 mg GTx-024</arm_group_label>
    <arm_group_label>3 mg GTx-024</arm_group_label>
    <other_name>Enobosarm</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo study drug is identical in appearance to the GTx-024 study drug and contains polyethylene glycol 400 but not GTx-024.</description>
    <arm_group_label>matching placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  SUI symptoms of at least 6 months duration&#xD;
&#xD;
          -  Predominant SUI as determined at the Screening Visit using the Medical,&#xD;
             Epidemiological, and Social Aspects of Aging (MESA) urinary questionnaire.&#xD;
&#xD;
          -  24-Hour pad weight &gt; 3 g during the screening period&#xD;
&#xD;
          -  A minimum of 1 and no more than 15 SUI episodes on any single day AND no fewer than 9&#xD;
             total SUI episodes over 3 days during the screening period&#xD;
&#xD;
          -  Positive bladder stress test conducted during the Screening Visit&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  History of pelvic radiation treatment&#xD;
&#xD;
          -  History of urethral diverticula&#xD;
&#xD;
          -  History of urethral sling or anterior prolapse repair&#xD;
&#xD;
          -  Treatment with urethral bulking agents and/or other SUI procedure or surgery within&#xD;
             the 6 months prior to the Screening Visit&#xD;
&#xD;
          -  Known vesicoureteral reflux, vaginal prolapse beyond the introitus, or other&#xD;
             significant pelvic floor abnormalities&#xD;
&#xD;
          -  Urinary incontinence of neurogenic etiology&#xD;
&#xD;
          -  Morbidly obese (defined as 100 pounds over ideal body weight, or body mass index 40 or&#xD;
             greater)&#xD;
&#xD;
          -  Chronic hepatitis&#xD;
&#xD;
          -  Hepatic cirrhosis&#xD;
&#xD;
          -  Evidence of active infection with hepatitis B or hepatitis C&#xD;
&#xD;
          -  History of human immunodeficiency virus (HIV) infection&#xD;
&#xD;
          -  Subjects with a history of breast or endometrial cancer&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Female, 18 to 80 years of age, inclusive, at screening; having undergone spontaneous, medically induced, or surgical menopause prior to the start of the study</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kenneth M Peters, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oakland University, William Beaumont School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Urology Center of Alabama</name>
      <address>
        <city>Homewood</city>
        <state>Alabama</state>
        <zip>35209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coastal Clinical Research Inc</name>
      <address>
        <city>Mobile</city>
        <state>Alabama</state>
        <zip>36608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alaska Clinical Research Center</name>
      <address>
        <city>Anchorage</city>
        <state>Alaska</state>
        <zip>99503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic Arizona</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85054</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Urological Associates of Southern Arizona</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85741</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Women's Healthcare Research Corporation</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>American Institute of Research</name>
      <address>
        <city>Whittier</city>
        <state>California</state>
        <zip>90603</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Genitourinary Surgical Consultants</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80220</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Urology Associates Research</name>
      <address>
        <city>Englewood</city>
        <state>Colorado</state>
        <zip>80113</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Women's Health Specialty Care</name>
      <address>
        <city>Farmington</city>
        <state>Connecticut</state>
        <zip>06032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coastal Connecticut Research, LLC</name>
      <address>
        <city>New London</city>
        <state>Connecticut</state>
        <zip>06320</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bladder Control Center of Connecticut</name>
      <address>
        <city>Norwalk</city>
        <state>Connecticut</state>
        <zip>06859</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>James A Simon MD PC</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20036</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Florida Medical Research</name>
      <address>
        <city>Aventura</city>
        <state>Florida</state>
        <zip>33180</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tampa Bay Medical Research Inc</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33761</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Midland Florida Clinical Research Center LLC</name>
      <address>
        <city>DeLand</city>
        <state>Florida</state>
        <zip>32720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Precision Clinical Research</name>
      <address>
        <city>Lauderdale Lakes</city>
        <state>Florida</state>
        <zip>33319</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lone Star Research Center</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33145</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Research of Florida</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33186</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Center of Florida</name>
      <address>
        <city>Pompano Beach</city>
        <state>Florida</state>
        <zip>33060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Vernon Clinical Research LLC</name>
      <address>
        <city>Sandy Springs</city>
        <state>Georgia</state>
        <zip>30328</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Prime</name>
      <address>
        <city>Idaho Falls</city>
        <state>Idaho</state>
        <zip>83221</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Idaho Urologic Institue</name>
      <address>
        <city>Meridian</city>
        <state>Idaho</state>
        <zip>83642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Women's Health Institution of Illinois</name>
      <address>
        <city>Oak Lawn</city>
        <state>Illinois</state>
        <zip>60453</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>First Urology PSC</name>
      <address>
        <city>Jeffersonville</city>
        <state>Indiana</state>
        <zip>47130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Iowa Clinic</name>
      <address>
        <city>West Des Moines</city>
        <state>Iowa</state>
        <zip>50266</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DelRicht Clinical Research, LLC</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regional Urology</name>
      <address>
        <city>Shreveport</city>
        <state>Louisiana</state>
        <zip>71106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chesapeake Urology Associates PA</name>
      <address>
        <city>Hanover</city>
        <state>Maryland</state>
        <zip>21076</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boston Clinical Trials</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bay State clinical Trials</name>
      <address>
        <city>Watertown</city>
        <state>Massachusetts</state>
        <zip>02472</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beyer Research</name>
      <address>
        <city>Kalamazoo</city>
        <state>Michigan</state>
        <zip>49009</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>William Beaumont Hospital Urology Research</name>
      <address>
        <city>Royal Oak</city>
        <state>Michigan</state>
        <zip>48073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Women's Clinic of Lincoln</name>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sheldon J Freedman MD Ltd</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Premier Urology Group, LL</name>
      <address>
        <city>Edison</city>
        <state>New Jersey</state>
        <zip>08837</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lawrence Obs Gyn clinical Research</name>
      <address>
        <city>Lawrenceville</city>
        <state>New Jersey</state>
        <zip>08648</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Delaware Valley Urology</name>
      <address>
        <city>Mount Laurel</city>
        <state>New Jersey</state>
        <zip>08054</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Accumed Research Associates</name>
      <address>
        <city>Garden City</city>
        <state>New York</state>
        <zip>11530</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Manhattan Medical Research Practice PLLC</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Premier Medical Group</name>
      <address>
        <city>Poughkeepsie</city>
        <state>New York</state>
        <zip>12601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Circuit Clinical</name>
      <address>
        <city>West Seneca</city>
        <state>New York</state>
        <zip>14224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>American Health Research Inc</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alliance Urology Specialist PA</name>
      <address>
        <city>Greensboro</city>
        <state>North Carolina</state>
        <zip>27403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eastern Carolina Women's</name>
      <address>
        <city>New Bern</city>
        <state>North Carolina</state>
        <zip>28562</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Urology Group</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aventiv Research</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute for Female Pelvic Medicine</name>
      <address>
        <city>Allentown</city>
        <state>Pennsylvania</state>
        <zip>18103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Urologic Consultants of Southeastern PA LLP</name>
      <address>
        <city>Bala-Cynwyd</city>
        <state>Pennsylvania</state>
        <zip>19004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania Health System</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coastal Carolina Research Center</name>
      <address>
        <city>Mount Pleasant</city>
        <state>South Carolina</state>
        <zip>29464</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolina Urologic Research</name>
      <address>
        <city>Myrtle Beach</city>
        <state>South Carolina</state>
        <zip>29572</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Jackson Clinic</name>
      <address>
        <city>Jackson</city>
        <state>Tennessee</state>
        <zip>38305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elligo - Austin Area OBGYN</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78758</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Urology Clinics of North Texas</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trials of Texas Incorporated</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Urology San Antonio Research PA</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Clinical Research Advantage, Inc. - Wasatch Peak Family Practice</name>
      <address>
        <city>Layton</city>
        <state>Utah</state>
        <zip>84041</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Urology of Virginia</name>
      <address>
        <city>Virginia Beach</city>
        <state>Virginia</state>
        <zip>23462</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Urology Northwest PS</name>
      <address>
        <city>Mountlake Terrace</city>
        <state>Washington</state>
        <zip>98043</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seattle Womens: Health, Research, Gynocology</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>August 2, 2017</study_first_submitted>
  <study_first_submitted_qc>August 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <results_first_submitted>October 20, 2020</results_first_submitted>
  <results_first_submitted_qc>October 20, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">November 12, 2020</results_first_posted>
  <last_update_submitted>March 3, 2021</last_update_submitted>
  <last_update_submitted_qc>March 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 24, 2021</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>Urinary Incontinence</mesh_term>
    <mesh_term>Enuresis</mesh_term>
    <mesh_term>Urinary Incontinence, Stress</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 10, 1018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/42/NCT03241342/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>1 mg GTx-024</title>
          <description>Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily.&#xD;
GTx 024: Study drug is an opaque, white to off-white, size 5, oval Softgel capsule containing the active ingredient GTx-024.</description>
        </group>
        <group group_id="P2">
          <title>3 mg GTx-024</title>
          <description>Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily.&#xD;
GTx 024: Study drug is an opaque, white to off-white, size 5, oval Softgel capsule containing the active ingredient GTx-024.</description>
        </group>
        <group group_id="P3">
          <title>Matching Placebo</title>
          <description>Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily.&#xD;
Placebo: Placebo study drug is identical in appearance to the GTx-024 study drug and contains polyethylene glycol 400 but not GTx-024.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="163"/>
                <participants group_id="P2" count="163"/>
                <participants group_id="P3" count="165"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="141"/>
                <participants group_id="P2" count="132"/>
                <participants group_id="P3" count="138"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="31"/>
                <participants group_id="P3" count="27"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>noncompliance with study drug</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>sponsor decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>not reported</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="21"/>
                <participants group_id="P3" count="19"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>1 mg GTx-024</title>
          <description>Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily.&#xD;
GTx 024: Study drug is an opaque, white to off-white, size 5, oval Softgel capsule containing the active ingredient GTx-024.</description>
        </group>
        <group group_id="B2">
          <title>3 mg GTx-024</title>
          <description>Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily.&#xD;
GTx 024: Study drug is an opaque, white to off-white, size 5, oval Softgel capsule containing the active ingredient GTx-024.</description>
        </group>
        <group group_id="B3">
          <title>Matching Placebo</title>
          <description>Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily.&#xD;
Placebo: Placebo study drug is identical in appearance to the GTx-024 study drug and contains polyethylene glycol 400 but not GTx-024.</description>
        </group>
        <group group_id="B4">
          <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="163"/>
            <count group_id="B2" value="163"/>
            <count group_id="B3" value="165"/>
            <count group_id="B4" value="491"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60" lower_limit="42" upper_limit="80"/>
                    <measurement group_id="B2" value="59" lower_limit="40" upper_limit="79"/>
                    <measurement group_id="B3" value="58" lower_limit="44" upper_limit="80"/>
                    <measurement group_id="B4" value="59" lower_limit="40" upper_limit="80"/>
                  </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="163"/>
                    <measurement group_id="B2" value="163"/>
                    <measurement group_id="B3" value="165"/>
                    <measurement group_id="B4" value="491"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</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_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="13"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="149"/>
                    <measurement group_id="B2" value="152"/>
                    <measurement group_id="B3" value="150"/>
                    <measurement group_id="B4" value="451"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="2"/>
                  </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="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="3"/>
                  </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="1"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="57"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="131"/>
                    <measurement group_id="B2" value="139"/>
                    <measurement group_id="B3" value="150"/>
                    <measurement group_id="B4" value="420"/>
                  </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_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline number of stress incontinence episodes per day</title>
          <units>episodes per day</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.588" lower_limit="3" upper_limit="11.67"/>
                    <measurement group_id="B2" value="4.329" lower_limit="3" upper_limit="12.67"/>
                    <measurement group_id="B3" value="4.459" lower_limit="3" upper_limit="12"/>
                    <measurement group_id="B4" value="4.4" lower_limit="3" upper_limit="12.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With a ≥ 50% Reduction From Baseline in the Mean Number of Stress Incontinence Episodes Per Day at Week 12</title>
        <description>Mean number of subject-reported stress incontinence episodes per day through a responder analysis, where a responder is defined as having a ≥ 50% reduction at the end of treatment (Week 12) compared to baseline in the number of stress incontinence episodes</description>
        <time_frame>12 Weeks</time_frame>
        <population>full analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>1 mg GTx-024</title>
            <description>Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily.&#xD;
GTx 024: Study drug is an opaque, white to off-white, size 5, oval Softgel capsule containing the active ingredient GTx-024.</description>
          </group>
          <group group_id="O2">
            <title>3 mg GTx-024</title>
            <description>Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily.&#xD;
GTx 024: Study drug is an opaque, white to off-white, size 5, oval Softgel capsule containing the active ingredient GTx-024.</description>
          </group>
          <group group_id="O3">
            <title>Matching Placebo</title>
            <description>Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily.&#xD;
Placebo: Placebo study drug is identical in appearance to the GTx-024 study drug and contains polyethylene glycol 400 but not GTx-024.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With a ≥ 50% Reduction From Baseline in the Mean Number of Stress Incontinence Episodes Per Day at Week 12</title>
          <description>Mean number of subject-reported stress incontinence episodes per day through a responder analysis, where a responder is defined as having a ≥ 50% reduction at the end of treatment (Week 12) compared to baseline in the number of stress incontinence episodes</description>
          <population>full analysis set</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
                <count group_id="O2" value="163"/>
                <count group_id="O3" value="165"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94"/>
                    <measurement group_id="O2" value="96"/>
                    <measurement group_id="O3" value="87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>7 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>1 mg GTx-024</title>
          <description>Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily.&#xD;
GTx 024: Study drug is an opaque, white to off-white, size 5, oval Softgel capsule containing the active ingredient GTx-024.</description>
        </group>
        <group group_id="E2">
          <title>3 mg GTx-024</title>
          <description>Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily.&#xD;
GTx 024: Study drug is an opaque, white to off-white, size 5, oval Softgel capsule containing the active ingredient GTx-024.</description>
        </group>
        <group group_id="E3">
          <title>Matching Placebo</title>
          <description>Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily.&#xD;
Placebo: Placebo study drug is identical in appearance to the GTx-024 study drug and contains polyethylene glycol 400 but not GTx-024.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="165"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>acute myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>goiter</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>abscessed limb</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>osteomyelitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>hip fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>spinal disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>cerebral vascular accident</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>dysaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>pulmonary congestion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <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="105" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="104" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="96" subjects_at_risk="165"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>anemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>lymphadenopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>polycythaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>thrombocytosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>acute myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>cardiomegaly</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>palpitations</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>ear discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>motion sickness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>vertigo</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>goiter</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>hypothyroidism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>blepharitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>chalazion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>dry eye</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>eye discharge</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>eye pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>eye swelling</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>vision blurred</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>visual impairment</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>abdominal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>abdominal hernia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>abdominal pain lower</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>change of bowel habit</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>colitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>constipation</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>diarrhea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>diverticulum</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>dry mouth</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>eructation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>flatulence</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>food poisoning</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>gastritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>hemorrhoids</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>nausea</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>oesophageal stenosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>vomiting</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>cyst</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>energy increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>fatigue</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>feeling abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>feeling hot</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>hypothermia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>influenza like illness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>malaise</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>non cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>peripheral swelling</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>polyp</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>thirst</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>abscess limb</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>acute sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>candida infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>clostridium difficile infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>diverticulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>ear infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>escherichia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>eye infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>fungal infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>gastroenteritis viral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>genital herpes</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>herpes zoster</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>influenza</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>localized infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>mycoplasma infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>osteomyelitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>otitis media acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>post procedural infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>respiratory tract infection viral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>rhinitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>streptococcal infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>tooth infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="29" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="18" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>urinary tract infection fungal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>vaginal infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>viral infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>vulvovaginal mycotic infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </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" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>contusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>fall</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>foot fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>hip fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>joint injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>laceration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>ligament rupture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>ligament sprain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>post procedural haematoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>procedural pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>radius fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>rib fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>soft tissue injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>sternal fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>tendon rupture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>tibia fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>tooth fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>alanine aminotransferase increasae</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>aspartate aminotransferase increase</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>blood alkaline phosphatase increase</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>blood creatinine phophokinase mb increase</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>blood creatinine phosphokinase increase</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>blood creatinine decrease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>blood creatinine increase</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>blood glucose increase</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>blood pressure increase</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>blood urine present</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>c reactive protein increase</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>back pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>fibromyalgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>intervertebral disc protrusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>limb discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>muscle weakness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>musculoskeletal chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>musculoskeletal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>myalgia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>neck pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>poly arthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>rotator cuff syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>spinal disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>systemic lupus erythematosus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>tendonitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>gastrointestinal tract adenoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>laryngeal papilloma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>burning sensation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>cerebrovascular accident</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>dizziness</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>dysaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>dysarthria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>headache</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>memory impairment</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>migraine</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>neuropathy peripheral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>sciatica</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>somnolence</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>tension headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>affect lability</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>agitation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>anger</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>anxiety</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>attention deficit hyperactivity disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>bruxism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>confusional state</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>depression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>emotional disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>insomnia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>irritability</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>libido increase</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>mental disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>sleep disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>azotemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>bladder disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>bladder pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>contracted bladder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>dysuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>hematuria</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>leukocyturia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>micturition urgency</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>nephrolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>nocturia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>polyuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>stress urinary incontinence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>urethral caruncle</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>urinary incontinence</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>urinary retention</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>urine odor abnormal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>breast cyst</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>breast tenderness</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>clitoral engorgement</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>coital bleeding</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>cystocele</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>endometrial thickening</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>hydrometra</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>ovarian cyst</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>pelvic congestion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>pelvic pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>uterine polyp</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>vaginal discharge</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>vaginal enlargement</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>vaginal hemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>vaginal lesion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>vulva cyst</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>vulvovaginal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>vulvovaginal pruritus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>asthma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>cough</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>dysphonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>nasal congestion</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>productive cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>pulmonary congestion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>pulmonary mass</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>reflux laryngitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>respiratory tract congestion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>sinus congestion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>sleep apnea syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>throat irritation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>upper airway cough syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>wheezing</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>urticaria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>acne</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>alopecia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>dermatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>dermatitis atopic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>dry skin</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>ecchymosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>eczema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>hirsutism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>hyperhidrosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>photosensitivity reaction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>pruritus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>rash</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>rash papular</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>rosacea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>seborrhoea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>skin exfoliation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>skin irritation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>aortic aneurysm</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>flushing</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>hot flush</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>hypertension</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>hypertensive crisis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="165"/>
              </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>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Mary Breitmeyer</name_or_title>
      <organization>Oncternal</organization>
      <phone>858-434-1113</phone>
      <email>MBreitmeyer@oncternal.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03241342
org study id: G201002
nct id: NCT03241342
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
GTx-024 is an orally bioavailable and tissue-selective nonsteroidal selective androgen
      receptor modulator (SARM) that has demonstrated androgenic and anabolic activity and is
      currently being evaluated as a potential treatment for stress urinary incontinence (SUI) in
      postmenopausal women. Urinary incontinence and pelvic floor disorders are major health
      problems for women, especially as they age. Pelvic floor muscle relaxation has been found to
      correlate with lower urinary tract symptoms including SUI. Muscles of the pelvic floor and
      lower urinary tract are crucial for supporting the pelvic organs and micturition; however,
      damage to the muscles or lack of hormonal stimulation are thought to contribute to pelvic
      organ prolapse and urinary incontinence. Although anabolic steroids may increase muscle mass
      and strength, lack of oral bioavailability and known potential risks have limited their use.
      Nonsteroidal SARMs have potential to achieve benefits of anabolic steroid therapy (improved
      muscle mass, cholesterol/triglyceride levels, glucose metabolism, and bone density) with
      fewer adverse effects, such as hirsutism and acne, in women. Both nonclinical and clinical
      data suggest that SARMs may provide a new therapeutic option for pelvic floor and lower
      urinary tract disorders, as both testosterone and its more potent metabolite,
      dihydrotestosterone, have anabolic effects on muscle.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Double-blind, placebo-controlled, parallel design, randomized, multicenter, Phase 2 study consisting of the following periods: screening period, treatment period, and follow-up period.
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Number of Participants With a ≥ 50% Reduction From Baseline in the Mean Number of Stress Incontinence Episodes Per Day at Week 12
time frame: 12 Weeks
description: Mean number of subject-reported stress incontinence episodes per day through a responder analysis, where a responder is defined as having a ≥ 50% reduction at the end of treatment (Week 12) compared to baseline in the number of stress incontinence episodes
arm group label: 1 mg GTx-024
arm group type: Active Comparator
description: Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily.
arm group label: 3 mg GTx-024
arm group type: Active Comparator
description: Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily.
arm group label: matching placebo
arm group type: Placebo Comparator
description: Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily.
intervention type: Drug
intervention name: GTx 024
description: Study drug is an opaque, white to off-white, size 5, oval Softgel capsule containing the active ingredient GTx-024.
arm group label: 1 mg GTx-024
arm group label: 3 mg GTx-024
other name: Enobosarm
intervention type: Drug
intervention name: Placebo
description: Placebo study drug is identical in appearance to the GTx-024 study drug and contains polyethylene glycol 400 but not GTx-024.
arm group label: matching placebo
criteria: 
gender: Female
gender based: Yes
gender description: Female, 18 to 80 years of age, inclusive, at screening; having undergone spontaneous, medically induced, or surgical menopause prior to the start of the study
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Kenneth M Peters, MD
role: Principal Investigator
affiliation: Oakland University, William Beaumont School of Medicine
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country: United States
responsible party type: Sponsor
mesh term: Urinary Incontinence
mesh term: Enuresis
mesh term: Urinary Incontinence, Stress
sharing ipd: No
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