<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/NCT03036124</url>
  </required_header>
  <id_info>
    <org_study_id>D1699C00001</org_study_id>
    <secondary_id>2016-003897-41</secondary_id>
    <nct_id>NCT03036124</nct_id>
  </id_info>
  <brief_title>Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients With Chronic Heart Failure</brief_title>
  <acronym>DAPA-HF</acronym>
  <official_title>Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients With Chronic Heart Failure With Reduced Ejection Fraction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AstraZeneca</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the effect of dapagliflozin on the incidence of&#xD;
      worsening heart failure or cardiovascular death in patients with chronic heart failure with&#xD;
      reduced ejection fraction&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an international, multicentre, parallel group, event-driven, randomized,&#xD;
      double-blind, placebo-controlled study in patients with chronic heart failure with reduced&#xD;
      ejection fraction (HFrEF), evaluating the effect of dapagliflozin versus placebo, given once&#xD;
      daily in addition to background regional standard of care therapy, for the prevention of&#xD;
      cardiovascular (CV) death or reduction of heart failure (HF) events.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 8, 2017</start_date>
  <completion_date type="Actual">July 17, 2019</completion_date>
  <primary_completion_date type="Actual">July 17, 2019</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Subjects Included in the Composite Endpoint of CV Death, Hospitalization Due to Heart Failure or Urgent Visit Due to Heart Failure.</measure>
    <time_frame>Up to 27.8 months.</time_frame>
    <description>Primary efficacy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subjects Included in the Composite Endpoint of CV Death or Hospitalization Due to Heart Failure.</measure>
    <time_frame>Up to 27.8 months.</time_frame>
    <description>Secondary</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Events Included in the Composite Endpoint of Recurrent Hospitalizations Due to Heart Failure and CV Death.</measure>
    <time_frame>Up to 27.8 months.</time_frame>
    <description>Secondary</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the KCCQ Total Symptom Score</measure>
    <time_frame>Baseline and 8 months or death before 8 months</time_frame>
    <description>KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. The KCCQ total symptom score incorporates the symptom domains into a single score. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjects Included in the Composite Endpoint of ≥50% Sustained Decline in eGFR, ESRD or Renal Death.</measure>
    <time_frame>Up to 27.8 months.</time_frame>
    <description>Secondary</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjects Included in the Endpoint of All-cause Mortality.</measure>
    <time_frame>Up to 27.8 months.</time_frame>
    <description>Secondary</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">4744</enrollment>
  <condition>Chronic Heart Failure With Reduced Ejection Fraction (HFrEF)</condition>
  <arm_group>
    <arm_group_label>Dapagliflozin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will be randomized 1:1 to either dapagliflozin or placebo.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo matching dapagliflozin.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dapagliflozin</intervention_name>
    <description>10 mg or 5 mg tablets given once daily, per oral use.</description>
    <arm_group_label>Dapagliflozin</arm_group_label>
    <other_name>Forxiga TM</other_name>
    <other_name>Farxiga TM</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo matching dapagliflozin 10 mg or 5 mg.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Provision of signed informed consent prior to any study specific procedures&#xD;
&#xD;
          -  Male or female, aged ≥18 years&#xD;
&#xD;
          -  Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV),&#xD;
             which has been present for at least 2 months&#xD;
&#xD;
          -  LVEF≤40%&#xD;
&#xD;
          -  Elevated NT-proBNP levels&#xD;
&#xD;
          -  Patients should receive background standard of care for HFrEF and be treated according&#xD;
             to locally recognized guidelines&#xD;
&#xD;
          -  eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or&#xD;
             previous intolerance of an SGLT2 inhibitor&#xD;
&#xD;
          -  Type 1 diabetes mellitus&#xD;
&#xD;
          -  Symptomatic hypotension or systolic BP &lt;95 mmHg at 2 out of 3 measurements either at&#xD;
             visit 1 or visit 2&#xD;
&#xD;
          -  Current acute decompensated HF or hospitalization due to decompensated HF &lt;4 weeks&#xD;
             prior to enrolment&#xD;
&#xD;
          -  MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to&#xD;
             enrolment&#xD;
&#xD;
          -  Coronary revascularization (percutaneous coronary intervention or coronary artery&#xD;
             bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or&#xD;
             planned to undergo any of these operations after randomization&#xD;
&#xD;
          -  Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT&#xD;
             device&#xD;
&#xD;
          -  Previous cardiac transplantation or implantation of a ventricular assistance device or&#xD;
             similar device, or implantation expected after randomization&#xD;
&#xD;
          -  HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis,&#xD;
             hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease&#xD;
&#xD;
          -  Symptomatic bradycardia or second or third degree heart block without a pacemaker&#xD;
&#xD;
          -  Severe (eGFR &lt;30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal&#xD;
             disease at the time of randomization&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>130 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Fairhope</city>
        <state>Alabama</state>
        <zip>36532</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Mobile</city>
        <state>Alabama</state>
        <zip>36608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sheffield</city>
        <state>Alabama</state>
        <zip>35660</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bakersfield</city>
        <state>California</state>
        <zip>93309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Beverly Hills</city>
        <state>California</state>
        <zip>90211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Palm Springs</city>
        <state>California</state>
        <zip>92262</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Stockton</city>
        <state>California</state>
        <zip>95204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <zip>90502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Vista</city>
        <state>California</state>
        <zip>92083</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Wilmington</city>
        <state>Delaware</state>
        <zip>19803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Boynton Beach</city>
        <state>Florida</state>
        <zip>33472</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lake Worth</city>
        <state>Florida</state>
        <zip>33461</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33125</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33155</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Naples</city>
        <state>Florida</state>
        <zip>34102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>New Smyrna Beach</city>
        <state>Florida</state>
        <zip>32169</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Pembroke Pines</city>
        <state>Florida</state>
        <zip>33024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Port Charlotte</city>
        <state>Florida</state>
        <zip>33952</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Saint Augustine</city>
        <state>Florida</state>
        <zip>32086</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Wellington</city>
        <state>Florida</state>
        <zip>33449</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Cumming</city>
        <state>Georgia</state>
        <zip>30041</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tucker</city>
        <state>Georgia</state>
        <zip>30084</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hazel Crest</city>
        <state>Illinois</state>
        <zip>60429</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Jerseyville</city>
        <state>Illinois</state>
        <zip>62052</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Peoria</city>
        <state>Illinois</state>
        <zip>61614</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Alexandria</city>
        <state>Louisiana</state>
        <zip>71301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Chalmette</city>
        <state>Louisiana</state>
        <zip>70043</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bangor</city>
        <state>Maine</state>
        <zip>04401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21228</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Columbia</city>
        <state>Maryland</state>
        <zip>21044</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Haverhill</city>
        <state>Massachusetts</state>
        <zip>01830</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Flint</city>
        <state>Michigan</state>
        <zip>48504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Flint</city>
        <state>Michigan</state>
        <zip>48532</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lansing</city>
        <state>Michigan</state>
        <zip>48910</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55407</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55417</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tupelo</city>
        <state>Mississippi</state>
        <zip>38801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Great Falls</city>
        <state>Montana</state>
        <zip>59405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Grand Island</city>
        <state>Nebraska</state>
        <zip>68803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68526</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bridgewater</city>
        <state>New Jersey</state>
        <zip>08807</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>New Brunswick</city>
        <state>New Jersey</state>
        <zip>08901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Somerset</city>
        <state>New Jersey</state>
        <zip>08873</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10459</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Cortlandt Manor</city>
        <state>New York</state>
        <zip>10567</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
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    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Brazil</country>
    <country>Bulgaria</country>
    <country>Canada</country>
    <country>China</country>
    <country>Czechia</country>
    <country>Denmark</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>India</country>
    <country>Japan</country>
    <country>Netherlands</country>
    <country>Poland</country>
    <country>Russian Federation</country>
    <country>Slovakia</country>
    <country>Sweden</country>
    <country>Taiwan</country>
    <country>United Kingdom</country>
    <country>United States</country>
    <country>Vietnam</country>
  </location_countries>
  <removed_countries>
    <country>Czech Republic</country>
  </removed_countries>
  <link>
    <url>https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;amp;parentIdentifier=D1699C00001&amp;amp;attachmentIdentifier=66b47cad-8320-450c-8663-8298a1e7f535&amp;amp;fileName=D1699C00001_Protocol_redacted.pdf&amp;amp;versionIdentifier=</url>
    <description>redacted protocol</description>
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  <link>
    <url>https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;amp;parentIdentifier=D1699C00001&amp;amp;attachmentIdentifier=0dea388e-44d4-4c23-9555-8aea2ea3448d&amp;amp;fileName=D1699C00001_Statistical_Analysis_Plan_redacted.pdf&amp;amp;versionIdentifier=</url>
    <description>redacted Statistical Analysis Plan</description>
  </link>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>January 26, 2017</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <results_first_submitted>July 6, 2020</results_first_submitted>
  <results_first_submitted_qc>August 31, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">September 1, 2020</results_first_posted>
  <last_update_submitted>August 31, 2020</last_update_submitted>
  <last_update_submitted_qc>August 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HFrEF</keyword>
  <keyword>Heart Failure (HF)</keyword>
  <keyword>Cardiovascular Events (CV)</keyword>
  <keyword>Phase III outcome trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dapagliflozin</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 26, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/24/NCT03036124/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 23, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/24/NCT03036124/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Dapa 10mg</title>
          <description>Dapagliflozin 10 mg, given once daily per oral use.</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="2373"/>
                <participants group_id="P2" count="2371"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2368"/>
                <participants group_id="P2" count="2365"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Dapa 10mg</title>
          <description>Dapagliflozin 10 mg, given once daily per oral use.</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="2373"/>
            <count group_id="B2" value="2371"/>
            <count group_id="B3" value="4744"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="66.2" spread="11.0"/>
                    <measurement group_id="B2" value="66.5" spread="10.8"/>
                    <measurement group_id="B3" value="66.3" spread="10.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=50</title>
                  <measurement_list>
                    <measurement group_id="B1" value="208"/>
                    <measurement group_id="B2" value="188"/>
                    <measurement group_id="B3" value="396"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;50</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2165"/>
                    <measurement group_id="B2" value="2183"/>
                    <measurement group_id="B3" value="4348"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=65</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1032"/>
                    <measurement group_id="B2" value="998"/>
                    <measurement group_id="B3" value="2030"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;65</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1341"/>
                    <measurement group_id="B2" value="1373"/>
                    <measurement group_id="B3" value="2714"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=65</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1032"/>
                    <measurement group_id="B2" value="998"/>
                    <measurement group_id="B3" value="2030"/>
                  </measurement_list>
                </category>
                <category>
                  <title>66 - 75</title>
                  <measurement_list>
                    <measurement group_id="B1" value="825"/>
                    <measurement group_id="B2" value="886"/>
                    <measurement group_id="B3" value="1711"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;75</title>
                  <measurement_list>
                    <measurement group_id="B1" value="516"/>
                    <measurement group_id="B2" value="487"/>
                    <measurement group_id="B3" value="1003"/>
                  </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="564"/>
                    <measurement group_id="B2" value="545"/>
                    <measurement group_id="B3" value="1109"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1809"/>
                    <measurement group_id="B2" value="1826"/>
                    <measurement group_id="B3" value="3635"/>
                  </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="381"/>
                    <measurement group_id="B2" value="387"/>
                    <measurement group_id="B3" value="768"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1992"/>
                    <measurement group_id="B2" value="1984"/>
                    <measurement group_id="B3" value="3976"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1662"/>
                    <measurement group_id="B2" value="1671"/>
                    <measurement group_id="B3" value="3333"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="122"/>
                    <measurement group_id="B2" value="104"/>
                    <measurement group_id="B3" value="226"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="552"/>
                    <measurement group_id="B2" value="564"/>
                    <measurement group_id="B3" value="1116"/>
                  </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="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Main etiology of HF</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Ischaemic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1316"/>
                    <measurement group_id="B2" value="1358"/>
                    <measurement group_id="B3" value="2674"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Non-Ischaemic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="857"/>
                    <measurement group_id="B2" value="830"/>
                    <measurement group_id="B3" value="1687"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="200"/>
                    <measurement group_id="B2" value="183"/>
                    <measurement group_id="B3" value="383"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Prior HF hospitalization</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1124"/>
                    <measurement group_id="B2" value="1127"/>
                    <measurement group_id="B3" value="2251"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>NYHA class at enrollment</title>
          <description>New York Heart Association (NYHA) Functional Classification places patients in one of four categories based on how much they are limited during physical activity; the limitations/symptoms are in regard to normal breathing and varying degrees in shortness of breath and/or angina. A higher class means a worse functional condition.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>II</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1606"/>
                    <measurement group_id="B2" value="1597"/>
                    <measurement group_id="B3" value="3203"/>
                  </measurement_list>
                </category>
                <category>
                  <title>III</title>
                  <measurement_list>
                    <measurement group_id="B1" value="747"/>
                    <measurement group_id="B2" value="751"/>
                    <measurement group_id="B3" value="1498"/>
                  </measurement_list>
                </category>
                <category>
                  <title>IV</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Type 2 diabetes at baseline</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1075"/>
                    <measurement group_id="B2" value="1064"/>
                    <measurement group_id="B3" value="2139"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1298"/>
                    <measurement group_id="B2" value="1307"/>
                    <measurement group_id="B3" value="2605"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>LVEF</title>
          <units>Percentage of blood leaving the heart</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31.2" spread="6.7"/>
                    <measurement group_id="B2" value="30.9" spread="6.9"/>
                    <measurement group_id="B3" value="31.1" spread="6.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Subjects Included in the Composite Endpoint of CV Death, Hospitalization Due to Heart Failure or Urgent Visit Due to Heart Failure.</title>
        <description>Primary efficacy</description>
        <time_frame>Up to 27.8 months.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dapa 10 mg</title>
            <description>Dapagliflozin 10 mg tablets administered orally once daily</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use.</description>
          </group>
        </group_list>
        <measure>
          <title>Subjects Included in the Composite Endpoint of CV Death, Hospitalization Due to Heart Failure or Urgent Visit Due to Heart Failure.</title>
          <description>Primary efficacy</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2373"/>
                <count group_id="O2" value="2371"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="386"/>
                    <measurement group_id="O2" value="502"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Regression, Cox</method>
            <method_desc>Stratified by Type 2 Diabetes status at randomization and including the history of hospitalizations due to Heart failure as a factor.</method_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.74</param_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>0.65</ci_lower_limit>
            <ci_upper_limit>0.85</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subjects Included in the Composite Endpoint of CV Death or Hospitalization Due to Heart Failure.</title>
        <description>Secondary</description>
        <time_frame>Up to 27.8 months.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dapa 10 mg</title>
            <description>Dapagliflozin 10 mg tablets administered orally once daily</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use.</description>
          </group>
        </group_list>
        <measure>
          <title>Subjects Included in the Composite Endpoint of CV Death or Hospitalization Due to Heart Failure.</title>
          <description>Secondary</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2373"/>
                <count group_id="O2" value="2371"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="382"/>
                    <measurement group_id="O2" value="495"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Regression, Cox</method>
            <method_desc>Stratified by Type 2 Diabetes status at randomization and including the history of hospitalizations due to Heart failure as a factor.</method_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.75</param_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>0.65</ci_lower_limit>
            <ci_upper_limit>0.85</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Events Included in the Composite Endpoint of Recurrent Hospitalizations Due to Heart Failure and CV Death.</title>
        <description>Secondary</description>
        <time_frame>Up to 27.8 months.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dapa 10 mg</title>
            <description>Dapagliflozin 10 mg tablets administered orally once daily</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use.</description>
          </group>
        </group_list>
        <measure>
          <title>Events Included in the Composite Endpoint of Recurrent Hospitalizations Due to Heart Failure and CV Death.</title>
          <description>Secondary</description>
          <units>events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2373"/>
                <count group_id="O2" value="2371"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="567"/>
                    <measurement group_id="O2" value="742"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0002</p_value>
            <method>LWYY proportional rates model</method>
            <method_desc>Stratified by Type 2 Diabetes status at randomization and including the history of hospitalizations due to Heart failure as a factor.</method_desc>
            <param_type>Rate Ratio (RR)</param_type>
            <param_value>0.75</param_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>0.65</ci_lower_limit>
            <ci_upper_limit>0.88</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the KCCQ Total Symptom Score</title>
        <description>KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. The KCCQ total symptom score incorporates the symptom domains into a single score. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.</description>
        <time_frame>Baseline and 8 months or death before 8 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dapa 10 mg</title>
            <description>Dapagliflozin 10 mg tablets administered orally once daily</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the KCCQ Total Symptom Score</title>
          <description>KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. The KCCQ total symptom score incorporates the symptom domains into a single score. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.</description>
          <units>Scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2373"/>
                <count group_id="O2" value="2371"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.1" spread="18.6"/>
                    <measurement group_id="O2" value="3.3" spread="19.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>The p-value is obtained from a rank ANCOVA adjusted for baseline KCCQ score and stratified by T2DM status at randomization.</p_value_desc>
            <method>Win Ratio</method>
            <method_desc>Stratified by Type 2 Diabetes status at randomization and including baseline score as a covariate.</method_desc>
            <param_type>Win Ratio (WR)</param_type>
            <param_value>1.18</param_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>1.11</ci_lower_limit>
            <ci_upper_limit>1.26</ci_upper_limit>
            <estimate_desc>The composite of change from baseline in total symptom score at 8 months, or death before 8 months.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subjects Included in the Composite Endpoint of ≥50% Sustained Decline in eGFR, ESRD or Renal Death.</title>
        <description>Secondary</description>
        <time_frame>Up to 27.8 months.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dapa 10 mg</title>
            <description>Dapagliflozin 10 mg tablets administered orally once daily</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use.</description>
          </group>
        </group_list>
        <measure>
          <title>Subjects Included in the Composite Endpoint of ≥50% Sustained Decline in eGFR, ESRD or Renal Death.</title>
          <description>Secondary</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2373"/>
                <count group_id="O2" value="2371"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1681</p_value>
            <method>Regression, Cox</method>
            <method_desc>Stratified by Type 2 Diabetes status at randomization and including baseline eGFR as a covariate.</method_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.71</param_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>0.44</ci_lower_limit>
            <ci_upper_limit>1.16</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subjects Included in the Endpoint of All-cause Mortality.</title>
        <description>Secondary</description>
        <time_frame>Up to 27.8 months.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dapa 10 mg</title>
            <description>Dapagliflozin 10 mg tablets administered orally once daily</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use.</description>
          </group>
        </group_list>
        <measure>
          <title>Subjects Included in the Endpoint of All-cause Mortality.</title>
          <description>Secondary</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2373"/>
                <count group_id="O2" value="2371"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="276"/>
                    <measurement group_id="O2" value="329"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0217</p_value>
            <method>Regression, Cox</method>
            <method_desc>Stratified by Type 2 Diabetes status at randomization.</method_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.83</param_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>0.71</ci_lower_limit>
            <ci_upper_limit>0.97</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 28.3 months.</time_frame>
      <desc>For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.</desc>
      <group_list>
        <group group_id="E1">
          <title>Dapa 10mg</title>
          <description>Dapagliflozin 10 mg, given once daily per oral use.</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 22.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="286" subjects_at_risk="2368"/>
                <counts group_id="E2" subjects_affected="333" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="895" subjects_at_risk="2368"/>
                <counts group_id="E2" subjects_affected="994" subjects_at_risk="2368"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="2368"/>
                <counts group_id="E2" events="13" subjects_affected="11" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Blood loss anaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Coagulopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Iron deficiency anaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Splenic infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute coronary syndrome</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="2368"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Acute left ventricular failure</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="37" subjects_affected="37" subjects_at_risk="2368"/>
                <counts group_id="E2" events="40" subjects_affected="38" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" events="12" subjects_affected="12" subjects_at_risk="2368"/>
                <counts group_id="E2" events="12" subjects_affected="12" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" events="24" subjects_affected="21" subjects_at_risk="2368"/>
                <counts group_id="E2" events="31" subjects_affected="30" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Aortic valve incompetence</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Aortic valve stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Arrhythmia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Arteriosclerosis coronary artery</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="27" subjects_affected="26" subjects_at_risk="2368"/>
                <counts group_id="E2" events="43" subjects_affected="39" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="2368"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Atrial tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Atrial thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Atrioventricular block complete</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2368"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Atrioventricular block second degree</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Bradyarrhythmia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Bundle branch block left</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Cardiac aneurysm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="2368"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Cardiac disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" events="380" subjects_affected="262" subjects_at_risk="2368"/>
                <counts group_id="E2" events="523" subjects_affected="351" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Cardiac failure acute</sub_title>
                <counts group_id="E1" events="58" subjects_affected="42" subjects_at_risk="2368"/>
                <counts group_id="E2" events="75" subjects_affected="59" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Cardiac failure chronic</sub_title>
                <counts group_id="E1" events="32" subjects_affected="27" subjects_at_risk="2368"/>
                <counts group_id="E2" events="46" subjects_affected="33" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" events="102" subjects_affected="65" subjects_at_risk="2368"/>
                <counts group_id="E2" events="106" subjects_affected="70" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Cardiac tamponade</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Cardiac valve disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Cardio-respiratory arrest</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Cardiogenic shock</sub_title>
                <counts group_id="E1" events="10" subjects_affected="9" subjects_at_risk="2368"/>
                <counts group_id="E2" events="16" subjects_affected="15" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Cardiomyopathy</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Cardiopulmonary failure</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Cardiorenal syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Cardiovascular insufficiency</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Chronic left ventricular failure</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Congestive cardiomyopathy</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" events="10" subjects_affected="9" subjects_at_risk="2368"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Coronary artery insufficiency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Coronary artery stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Extrasystoles</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Frederick's syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Ischaemic cardiomyopathy</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Left ventricular dysfunction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Left ventricular failure</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Low cardiac output syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Mitral valve incompetence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Myocardial fibrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="16" subjects_affected="16" subjects_at_risk="2368"/>
                <counts group_id="E2" events="17" subjects_affected="17" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Myocardial ischaemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2368"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Pericardial effusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Pericarditis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Prosthetic cardiac valve thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Pulseless electrical activity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Right ventricular failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Sinus node dysfunction</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Sinus tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Supraventricular tachycardia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2368"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Tachyarrhythmia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Torsade de pointes</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Tricuspid valve incompetence</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Ventricular arrhythmia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="2368"/>
                <counts group_id="E2" events="8" subjects_affected="7" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Ventricular extrasystoles</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Ventricular fibrillation</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="2368"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Ventricular tachyarrhythmia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Ventricular tachycardia</sub_title>
                <counts group_id="E1" events="41" subjects_affected="34" subjects_at_risk="2368"/>
                <counts group_id="E2" events="65" subjects_affected="54" subjects_at_risk="2368"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Vertigo positional</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Vestibular disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperthyroidism</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Angle closure glaucoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="2368"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Diabetic retinopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Glaucoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Optic ischaemic neuropathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Retinal artery occlusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Retinal detachment</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Strabismus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Vitreous haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal adhesions</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="2368"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Abdominal wall haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Chronic gastritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="2368"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Diverticulum intestinal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Diverticulum intestinal haemorrhagic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Duodenal ulcer haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Duodenal ulcer perforation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Duodenitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Enteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Gastric haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Gastric ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Gastric ulcer haemorrhage</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Gastritis erosive</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Gastritis haemorrhagic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Gastrointestinal angiectasia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Gastrointestinal angiodysplasia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Gastrointestinal disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="2368"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Gastrointestinal obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Gastrointestinal polyp haemorrhage</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Gastrointestinal ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Haematemesis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Haematochezia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Haemorrhoidal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Ileus paralytic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Inguinal hernia</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="2368"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Intestinal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Intestinal ischaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Intestinal perforation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Large intestine polyp</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Lower gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Megacolon</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Melaena</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Mesenteric artery thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Obstructive pancreatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Oesophageal ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Pancreatic disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Pancreatic mass</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Pancreatitis acute</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="2368"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Pancreatitis chronic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Rectal polyp</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Retroperitoneal haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Thrombosis mesenteric vessel</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Umbilical hernia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Upper gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="2368"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Cardiac death</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Chest discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="2368"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Complication associated with device</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" events="48" subjects_affected="48" subjects_at_risk="2368"/>
                <counts group_id="E2" events="48" subjects_affected="48" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>General physical health deterioration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Implant site haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Medical device site inflammation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Multiple organ dysfunction syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Necrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="2368"/>
                <counts group_id="E2" events="19" subjects_affected="16" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Sudden cardiac death</sub_title>
                <counts group_id="E1" events="18" subjects_affected="18" subjects_at_risk="2368"/>
                <counts group_id="E2" events="27" subjects_affected="27" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Sudden death</sub_title>
                <counts group_id="E1" events="19" subjects_affected="19" subjects_at_risk="2368"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Ulcer haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Vascular stent occlusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Vascular stent stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Vascular stent thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Bile duct obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Bile duct stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Bile duct stone</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Biliary dilatation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Cholangitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Cholangitis acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2368"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="2368"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Cholecystitis chronic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Cryptogenic cirrhosis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Drug-induced liver injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Gallbladder enlargement</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Hepatic cirrhosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Hepatic failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Hepatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Hepatitis acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Ischaemic hepatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Jaundice</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Jaundice cholestatic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Heart transplant rejection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abdominal abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Abdominal wall abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Abscess limb</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Acute sinusitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Anal abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Bacterial sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Biliary sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="13" subjects_affected="12" subjects_at_risk="2368"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Bursitis infective</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Cardiac infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="11" subjects_affected="9" subjects_at_risk="2368"/>
                <counts group_id="E2" events="12" subjects_affected="10" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Cellulitis gangrenous</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Cervicitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Clostridial infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Clostridium difficile colitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Clostridium difficile infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Dengue fever</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Device related infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2368"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Diabetic foot infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Diabetic gangrene</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Disseminated tuberculosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Endocarditis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Endocarditis bacterial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Endotoxic shock</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Enteritis infectious</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Enterococcal bacteraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Epididymitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Erysipelas</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Fournier's gangrene</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Furuncle</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Gangrene</sub_title>
                <counts group_id="E1" events="5" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2368"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Gastroenteritis rotavirus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Gastrointestinal infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Gastrointestinal viral infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Hiv infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Herpes zoster oticus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Implant site infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Infected dermal cyst</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Infected skin ulcer</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Infectious pleural effusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Intestinal sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Liver abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Localised infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Lung infection</sub_title>
                <counts group_id="E1" events="7" subjects_affected="4" subjects_at_risk="2368"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Lyme disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Mediastinal abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Medical device site infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Meningitis tuberculous</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Metapneumovirus infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Oral candidiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Oropharyngeal candidiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Osteomyelitis</sub_title>
                <counts group_id="E1" events="9" subjects_affected="7" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Otitis media</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Otitis media acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Perichondritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Periodontitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Peritonitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Peritonsillar abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="83" subjects_affected="76" subjects_at_risk="2368"/>
                <counts group_id="E2" events="87" subjects_affected="82" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Pneumonia bacterial</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Postoperative abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Postoperative wound infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Pulmonary sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Pulmonary tuberculosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Pyelocystitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Pyelonephritis acute</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Rectal abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Renal abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Renal cyst infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Respiratory syncytial virus infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2368"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Rickettsiosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="13" subjects_affected="13" subjects_at_risk="2368"/>
                <counts group_id="E2" events="14" subjects_affected="14" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="2368"/>
                <counts group_id="E2" events="9" subjects_affected="8" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Staphylococcal infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Subdiaphragmatic abscess</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Systemic candida</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Tracheobronchitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Tuberculosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="13" subjects_affected="11" subjects_at_risk="2368"/>
                <counts group_id="E2" events="17" subjects_affected="17" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Urinary tract infection staphylococcal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="2368"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Wound infection</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Abdominal wound dehiscence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Accidental overdose</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Acetabulum fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Alcohol poisoning</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Ankle fracture</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Bone contusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Brain contusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Brain herniation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Cardiac valve rupture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Compression fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Craniocerebral injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Femoral neck fracture</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="2368"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Fibula fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Foot fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Head injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Hip fracture</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Humerus fracture</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Joint dislocation</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Limb injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Lower limb fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Lumbar vertebral fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Multiple fractures</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Overdose</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Patella fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Pelvic fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Poisoning</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Post procedural haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Post procedural haematuria</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Post procedural haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Postoperative wound complication</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Road traffic accident</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Skin injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Skull fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Skull fractured base</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Spinal compression fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Spinal fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Splenic injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Subdural haematoma</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="2368"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Subdural haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Tendon injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Thermal burn</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Thoracic vertebral fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Toxicity to various agents</sub_title>
                <counts group_id="E1" events="4" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Traumatic haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Traumatic intracranial haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Upper limb fracture</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Wrist fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="2368"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Blood glucose increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Ejection fraction decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Glomerular filtration rate decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>International normalised ratio increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Pulmonary arterial pressure increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Troponin increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Cachexia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="2368"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Diabetes mellitus</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="2368"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Diabetes mellitus inadequate control</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Diabetic ketoacidosis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Diabetic ketosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Diabetic metabolic decompensation</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Fluid overload</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Fluid retention</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Gout</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2368"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Hyperglycaemic hyperosmolar nonketotic syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Hypovolaemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Ketoacidosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Lactic acidosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Steroid diabetes</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Type 2 diabetes mellitus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Arthritis reactive</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Chondrocalcinosis pyrophosphate</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Dupuytren's contracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Gouty arthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Intervertebral disc degeneration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Intervertebral disc protrusion</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Joint effusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Lumbar spinal stenosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="2368"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Osteonecrosis of jaw</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Pleural mass</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Polymyalgia rheumatica</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Pseudarthrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Spinal pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Spinal stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Spondyloarthropathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Spondylolisthesis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Abdominal neoplasm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Acute myeloid leukaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Adenocarcinoma of colon</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Benign breast neoplasm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Benign neoplasm of bladder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Benign uterine neoplasm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Bladder cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Bladder neoplasm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Bladder transitional cell carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Breast cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Breast cancer female</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Breast cancer recurrent</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Brenner tumour</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Cervix carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Cholangiocarcinoma</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Chronic lymphocytic leukaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Chronic myeloid leukaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Colon cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Colon cancer metastatic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Colon neoplasm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Colorectal adenocarcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Colorectal cancer metastatic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Ductal adenocarcinoma of pancreas</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Gastric cancer</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Gastrointestinal cancer metastatic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Glioblastoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Glioblastoma multiforme</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Hepatocellular carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Large intestine benign neoplasm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Laryngeal cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Leukaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Leukaemia recurrent</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Lung adenocarcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Lung cancer metastatic</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Lung neoplasm malignant</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="2368"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Malignant melanoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Malignant neoplasm of unknown primary site</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Meningioma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Metastases to central nervous system</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Metastases to liver</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Metastatic carcinoma of the bladder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Metastatic malignant melanoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Myelodysplastic syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Myelofibrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Nasal cavity cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Non-small cell lung cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Oesophageal carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Ovarian cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Pancreatic carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Pancreatic neoplasm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Papillary renal cell carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Pituitary tumour benign</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Plasma cell myeloma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Pleomorphic adenoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Polycythaemia vera</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Prostate cancer</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Rectal cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Renal cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Renal neoplasm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma of lung</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma of the tongue</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Tonsil cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Transitional cell carcinoma</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Brain injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Brain oedema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Brain stem infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Carotid artery stenosis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Cerebellar stroke</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Cerebral haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Cerebral haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="2368"/>
                <counts group_id="E2" events="12" subjects_affected="11" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Cerebral ischaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Cerebral thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="2368"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Diabetic ketoacidotic hyperglycaemic coma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Embolic stroke</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Epilepsy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Facial paralysis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Generalised tonic-clonic seizure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Haemorrhage intracranial</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Haemorrhagic stroke</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Haemorrhagic transformation stroke</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Iiird nerve paresis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Ischaemic cerebral infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Ischaemic stroke</sub_title>
                <counts group_id="E1" events="26" subjects_affected="24" subjects_at_risk="2368"/>
                <counts group_id="E2" events="28" subjects_affected="26" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Loss of consciousness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Nervous system disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Neuralgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Parkinson's disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Peroneal nerve palsy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Post herpetic neuralgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Sciatica</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Subarachnoid haemorrhage</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="2368"/>
                <counts group_id="E2" events="14" subjects_affected="13" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" events="13" subjects_affected="13" subjects_at_risk="2368"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Vascular dementia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Vascular encephalopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Vertebral artery occlusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Vertebral artery stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Vertebrobasilar insufficiency</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Device dislocation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Device failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Device inappropriate shock delivery</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Device lead issue</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Device malfunction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Lead dislodgement</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Alcohol withdrawal syndrome</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Anxiety disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Bipolar i disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Completed suicide</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Mental status changes</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Suicide attempt</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="25" subjects_affected="23" subjects_at_risk="2368"/>
                <counts group_id="E2" events="49" subjects_affected="46" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Anuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Bladder neck obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Chronic kidney disease</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="2368"/>
                <counts group_id="E2" events="10" subjects_affected="8" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Cystitis noninfective</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>End stage renal disease</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Hydronephrosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Nephropathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Nephropathy toxic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Postrenal failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Prerenal failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Renal artery stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Renal colic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Renal cyst</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Renal disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="2368"/>
                <counts group_id="E2" events="9" subjects_affected="8" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Renal impairment</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="2368"/>
                <counts group_id="E2" events="14" subjects_affected="13" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Renal injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Ureterolithiasis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Urethral stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Acquired hydrocele</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Adenomyosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Balanoposthitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Benign prostatic hyperplasia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Endometrial hyperplasia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Metrorrhagia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Orchitis noninfective</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Ovarian cyst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute pulmonary oedema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" events="9" subjects_affected="7" subjects_at_risk="2368"/>
                <counts group_id="E2" events="16" subjects_affected="14" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Aspiration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Bronchiectasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" events="16" subjects_affected="14" subjects_at_risk="2368"/>
                <counts group_id="E2" events="34" subjects_affected="22" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Chronic respiratory failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="2368"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Eosinophilic pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Interstitial lung disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Lung cyst</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Pharyngeal lesion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Pleurisy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Pleuritic pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Pneumomediastinum</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Pneumonia aspiration</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2368"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Pneumothorax spontaneous</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Pulmonary alveolar haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Pulmonary congestion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="2368"/>
                <counts group_id="E2" events="14" subjects_affected="14" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Pulmonary hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Pulmonary mass</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Pulmonary oedema</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="2368"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Pulmonary toxicity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Pulmonary vasculitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2368"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="2368"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Blister</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Decubitus ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Dermatitis allergic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Diabetic foot</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Drug eruption</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Petechiae</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Psoriasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Skin haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Skin necrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Skin ulcer</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Accelerated hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Angiodysplasia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Aortic aneurysm</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Aortic aneurysm rupture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Aortic dissection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Aortic stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Circulatory collapse</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2368"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Diabetic vascular disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Dry gangrene</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Embolism arterial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Essential hypertension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Extremity necrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Haematocoele</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Hypertensive crisis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2368"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Hypertensive emergency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Hypertensive urgency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="9" subjects_affected="7" subjects_at_risk="2368"/>
                <counts group_id="E2" events="12" subjects_affected="11" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Hypovolaemic shock</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Iliac artery occlusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Orthostatic hypotension</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2368"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Peripheral arterial occlusive disease</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="2368"/>
                <counts group_id="E2" events="11" subjects_affected="10" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Peripheral artery occlusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Peripheral artery stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Peripheral embolism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Peripheral ischaemia</sub_title>
                <counts group_id="E1" events="11" subjects_affected="9" subjects_at_risk="2368"/>
                <counts group_id="E2" events="8" subjects_affected="5" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Peripheral vascular disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Shock</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Thrombophlebitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Thrombophlebitis superficial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Vasculitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Venous thrombosis limb</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2368"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2368"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2</frequency_threshold>
        <default_vocab>MedDRA 22.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="299" subjects_at_risk="2368"/>
                <counts group_id="E2" subjects_affected="325" subjects_at_risk="2368"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="63" subjects_affected="58" subjects_at_risk="2368"/>
                <counts group_id="E2" events="55" subjects_affected="52" subjects_at_risk="2368"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" events="90" subjects_affected="76" subjects_at_risk="2368"/>
                <counts group_id="E2" events="154" subjects_affected="130" subjects_at_risk="2368"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="84" subjects_affected="63" subjects_at_risk="2368"/>
                <counts group_id="E2" events="100" subjects_affected="76" subjects_at_risk="2368"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal impairment</sub_title>
                <counts group_id="E1" events="67" subjects_affected="63" subjects_at_risk="2368"/>
                <counts group_id="E2" events="60" subjects_affected="56" subjects_at_risk="2368"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="98" subjects_affected="88" subjects_at_risk="2368"/>
                <counts group_id="E2" events="81" subjects_affected="73" subjects_at_risk="2368"/>
              </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 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>AstraZeneca Clinical Study Information Center</name_or_title>
      <organization>AstraZeneca</organization>
      <phone>+1-877-240-9479</phone>
      <email>information.center@astrazeneca.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03036124
org study id: D1699C00001
secondary id: 2016-003897-41
nct id: NCT03036124
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to evaluate the effect of dapagliflozin on the incidence of
      worsening heart failure or cardiovascular death in patients with chronic heart failure with
      reduced ejection fraction
This is an international, multicentre, parallel group, event-driven, randomized,
      double-blind, placebo-controlled study in patients with chronic heart failure with reduced
      ejection fraction (HFrEF), evaluating the effect of dapagliflozin versus placebo, given once
      daily in addition to background regional standard of care therapy, for the prevention of
      cardiovascular (CV) death or reduction of heart failure (HF) events.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Subjects Included in the Composite Endpoint of CV Death, Hospitalization Due to Heart Failure or Urgent Visit Due to Heart Failure.
time frame: Up to 27.8 months.
description: Primary efficacy
measure: Subjects Included in the Composite Endpoint of CV Death or Hospitalization Due to Heart Failure.
time frame: Up to 27.8 months.
description: Secondary
measure: Events Included in the Composite Endpoint of Recurrent Hospitalizations Due to Heart Failure and CV Death.
time frame: Up to 27.8 months.
description: Secondary
measure: Change From Baseline in the KCCQ Total Symptom Score
time frame: Baseline and 8 months or death before 8 months
description: KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. The KCCQ total symptom score incorporates the symptom domains into a single score. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
measure: Subjects Included in the Composite Endpoint of ≥50% Sustained Decline in eGFR, ESRD or Renal Death.
time frame: Up to 27.8 months.
description: Secondary
measure: Subjects Included in the Endpoint of All-cause Mortality.
time frame: Up to 27.8 months.
description: Secondary
arm group label: Dapagliflozin
arm group type: Experimental
description: Patients will be randomized 1:1 to either dapagliflozin or placebo.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo matching dapagliflozin.
intervention type: Drug
intervention name: Dapagliflozin
description: 10 mg or 5 mg tablets given once daily, per oral use.
arm group label: Dapagliflozin
other name: Forxiga TM
other name: Farxiga TM
intervention type: Drug
intervention name: Placebo
description: Placebo matching dapagliflozin 10 mg or 5 mg.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 130 Years
healthy volunteers: No
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country: Argentina
country: Brazil
country: Bulgaria
country: Canada
country: China
country: Czechia
country: Denmark
country: Germany
country: Hungary
country: India
country: Japan
country: Netherlands
country: Poland
country: Russian Federation
country: Slovakia
country: Sweden
country: Taiwan
country: United Kingdom
country: United States
country: Vietnam
country: Czech Republic
url: https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=D1699C00001&amp;attachmentIdentifier=66b47cad-8320-450c-8663-8298a1e7f535&amp;fileName=D1699C00001_Protocol_redacted.pdf&amp;versionIdentifier=
description: redacted protocol
url: https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=D1699C00001&amp;attachmentIdentifier=0dea388e-44d4-4c23-9555-8aea2ea3448d&amp;fileName=D1699C00001_Statistical_Analysis_Plan_redacted.pdf&amp;versionIdentifier=
description: redacted Statistical Analysis Plan
responsible party type: Sponsor
mesh term: Heart Failure
mesh term: Dapagliflozin
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 