<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/NCT03036150</url>
  </required_header>
  <id_info>
    <org_study_id>D169AC00001</org_study_id>
    <secondary_id>2016-003896-24</secondary_id>
    <nct_id>NCT03036150</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients With Chronic Kidney Disease</brief_title>
  <acronym>Dapa-CKD</acronym>
  <official_title>A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients With Chronic Kidney Disease</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 renal outcomes and&#xD;
      cardiovascular mortality in patients with chronic kidney disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an international, multicentre, event-driven, randomized, double-blind, parallel&#xD;
      group, placebo-controlled study, evaluating the effect of dapagliflozin versus placebo, given&#xD;
      once daily in addition to standard of care, to prevent the progression of chronic kidney&#xD;
      disease (CKD) or cardiovascular (CV)/renal death.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2, 2017</start_date>
  <completion_date type="Actual">June 12, 2020</completion_date>
  <primary_completion_date type="Actual">June 12, 2020</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>Time to the First Occurrence of Any of the Components of the Composite: ≥50% Sustained Decline in eGFR or Reaching ESRD or CV Death or Renal Death.</measure>
    <time_frame>Up to 38.2 months</time_frame>
    <description>End Stage Renal Disease (ESRD) is defined as:&#xD;
Sustained eGFR &lt;15 mL/min/1.73m2 or,&#xD;
Chronic dialysis treatment or,&#xD;
Receiving a renal transplant The proportional hazards Cox regression model takes into account the time to the event. Data is reported as the numbers of subjects with the event and the Hazard ratio is included in the Statistical Analysis section attached to the Outcome Measure data table.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to the First Occurrence of Any of the Components of the Composite: ≥50% Sustained Decline in eGFR or Reaching ESRD or Renal Death.</measure>
    <time_frame>Up to 38.2 months</time_frame>
    <description>End Stage Renal Disease (ESRD) is defined as:&#xD;
Sustained eGFR &lt;15 mL/min/1.73m2 or,&#xD;
Chronic dialysis treatment or,&#xD;
Receiving a renal transplant The proportional hazards Cox regression model takes into account the time to the event. Data is reported as the numbers of subjects with the event and the Hazard ratio is included in the Statistical Analysis section attached to the Outcome Measure data table.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to the First Occurrence of Either of the Components of the Composite: CV Death or Hospitalization for Heart Failure.</measure>
    <time_frame>Up to 38.2 months</time_frame>
    <description>The proportional hazards Cox regression model takes into account the time to the event. Data is reported as the numbers of subjects with the event and the Hazard ratio is included in the Statistical Analysis section attached to the Outcome Measure data table.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Death From Any Cause.</measure>
    <time_frame>Up to 38.2 months</time_frame>
    <description>The proportional hazards Cox regression model takes into account the time to the event. Data is reported as the numbers of subjects with the event and the Hazard ratio is included in the Statistical Analysis section attached to the Outcome Measure data table.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">4304</enrollment>
  <condition>Chronic Kidney Disease</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;
          -  Female or male aged ≥18 years at the time of consent&#xD;
&#xD;
          -  eGFR ≥25 and ≤75 mL/min/1.73m2 (CKD-EPI Formula) at visit 1&#xD;
&#xD;
          -  Evidence of increased albuminuria 3 months or more before visit 1 and UACR ≥200 and&#xD;
             ≤5000 mg/g at visit 1&#xD;
&#xD;
          -  Stable, and for the patient maximum tolerated labelled daily dose, treatment with&#xD;
             ACE-I or ARB for at least 4 weeks before visit 1, if not medically contraindicated,&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Autosomal dominant or autosomal recessive polycystic kidney disease, lupus nephritis&#xD;
             or ANCA-associated vasculitis&#xD;
&#xD;
          -  Receiving cytotoxic therapy, immunosuppressive therapy or other immunotherapy for&#xD;
             primary or secondary renal disease within 6 months prior to enrolment&#xD;
&#xD;
          -  History of organ transplantation&#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;
          -  New York Heart Association (NYHA) class IV Congestive Heart Failure at the time of&#xD;
             enrolment&#xD;
&#xD;
          -  MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to&#xD;
             enrolment&#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>Birmingham</city>
        <state>Alabama</state>
        <zip>35233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hawaiian Gardens</city>
        <state>California</state>
        <zip>90716</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lomita</city>
        <state>California</state>
        <zip>90717</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90022</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>San Dimas</city>
        <state>California</state>
        <zip>91773</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>San Ramon</city>
        <state>California</state>
        <zip>94582</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>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80246</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Boynton Beach</city>
        <state>Florida</state>
        <zip>33435</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>32224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Miami Lakes</city>
        <state>Florida</state>
        <zip>33014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33015</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33165</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 Port Richey</city>
        <state>Florida</state>
        <zip>34652</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30342-1797</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30904</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60643</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Topeka</city>
        <state>Kansas</state>
        <zip>66606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67214</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Metairie</city>
        <state>Louisiana</state>
        <zip>70006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</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>Duluth</city>
        <state>Minnesota</state>
        <zip>55805</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>Albany</city>
        <state>New York</state>
        <zip>12208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Asheville</city>
        <state>North Carolina</state>
        <zip>28801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hickory</city>
        <state>North Carolina</state>
        <zip>28601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>New Bern</city>
        <state>North Carolina</state>
        <zip>28562</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Maumee</city>
        <state>Ohio</state>
        <zip>43537</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Jersey Shore</city>
        <state>Pennsylvania</state>
        <zip>17740</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Greer</city>
        <state>South Carolina</state>
        <zip>29651</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kingsport</city>
        <state>Tennessee</state>
        <zip>37660</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>El Paso</city>
        <state>Texas</state>
        <zip>79935</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76116</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76164</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Odessa</city>
        <state>Texas</state>
        <zip>79761</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Burke</city>
        <state>Virginia</state>
        <zip>22015</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Manassas</city>
        <state>Virginia</state>
        <zip>20110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Newport News</city>
        <state>Virginia</state>
        <zip>23606</zip>
        <country>United States</country>
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  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>98405</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Buenos Aires</city>
        <zip>ARG 1425</zip>
        <country>Argentina</country>
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    </facility>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Buenos Aires</city>
        <zip>C1425BGN</zip>
        <country>Argentina</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
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        <zip>C1429BWN</zip>
        <country>Argentina</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
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        <zip>C1119ACN</zip>
        <country>Argentina</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Caba</city>
        <zip>C1120AAC</zip>
        <country>Argentina</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ciudad Autonoma Buenos Aires</city>
        <zip>1093</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Malmö</city>
        <zip>205 02</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Stockholm</city>
        <zip>141 86</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Stockholm</city>
        <zip>182 88</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Uppsala</city>
        <zip>751 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Cherkasy</city>
        <zip>18009</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Chernivtsі</city>
        <zip>58018</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Dnipro</city>
        <zip>49005</zip>
        <country>Ukraine</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Dnipro</city>
        <zip>49102</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ivano-Frankivsk</city>
        <zip>76008</zip>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ivano-Frankivsk</city>
        <zip>76018</zip>
        <country>Ukraine</country>
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  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kharkiv Region</city>
        <zip>61039</zip>
        <country>Ukraine</country>
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  </location>
  <location>
    <facility>
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  <location>
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        <zip>61166</zip>
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  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kyiv</city>
        <zip>02091</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kyiv</city>
        <zip>02125</zip>
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  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kyiv</city>
        <zip>04053</zip>
        <country>Ukraine</country>
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  </location>
  <location>
    <facility>
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      <address>
        <city>Kyiv</city>
        <zip>4050</zip>
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    </facility>
  </location>
  <location>
    <facility>
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      <address>
        <city>Lutsk</city>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Odesa</city>
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  <location>
    <facility>
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      <address>
        <city>Poltava</city>
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  <location>
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      <address>
        <city>Rivne</city>
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      <address>
        <city>Ternopil</city>
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      <address>
        <city>Vinnytsia</city>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Vinnytsia</city>
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    <facility>
      <name>Research Site</name>
      <address>
        <city>Zaporizhzhia</city>
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      <name>Research Site</name>
      <address>
        <city>Cardiff</city>
        <zip>CF14 4XW</zip>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Glasgow</city>
        <zip>G51 4TF</zip>
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  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hull</city>
        <zip>HU3 2JZ</zip>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kent</city>
        <zip>BR6 8ND</zip>
        <country>United Kingdom</country>
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  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Leicester</city>
        <zip>LE5 4PW</zip>
        <country>United Kingdom</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>London</city>
        <zip>E1 1BB</zip>
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  <location>
    <facility>
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        <city>London</city>
        <zip>SE5 9RS</zip>
        <country>United Kingdom</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Salford</city>
        <zip>M6 8HD</zip>
        <country>United Kingdom</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Swansea</city>
        <zip>SA6 6NL</zip>
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  <location>
    <facility>
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      <address>
        <city>Bien Hoa</city>
        <zip>810000</zip>
        <country>Vietnam</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hanoi</city>
        <zip>10000</zip>
        <country>Vietnam</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ho Chi Minh city</city>
        <zip>700000</zip>
        <country>Vietnam</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ho Chi Minh City</city>
        <zip>70000</zip>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ho Chi Minh City</city>
        <zip>9000</zip>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ho Chi Minh</city>
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      <name>Research Site</name>
      <address>
        <city>Ho Chi Minh</city>
        <zip>7000000</zip>
        <country>Vietnam</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hochiminh</city>
        <zip>700000</zip>
        <country>Vietnam</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Brazil</country>
    <country>Canada</country>
    <country>China</country>
    <country>Denmark</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>India</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Mexico</country>
    <country>Peru</country>
    <country>Philippines</country>
    <country>Poland</country>
    <country>Russian Federation</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>Ukraine</country>
    <country>United Kingdom</country>
    <country>United States</country>
    <country>Vietnam</country>
  </location_countries>
  <link>
    <url>https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;amp;parentIdentifier=D169AC00001&amp;amp;attachmentIdentifier=c59c2c03-ebfa-46f4-beac-d0b14b62db99&amp;amp;fileName=d169ac00001_csp_Redacted.pdf&amp;amp;versionIdentifier=</url>
    <description>redacted protocol</description>
  </link>
  <link>
    <url>https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;amp;parentIdentifier=D169AC00001&amp;amp;attachmentIdentifier=987ded9e-acd7-4718-a380-431a2b2d1377&amp;amp;fileName=d169ac00001_sap_Redacted.pdf&amp;amp;versionIdentifier=</url>
    <description>redacted Statistical Analysis Plan</description>
  </link>
  <verification_date>June 2021</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>April 19, 2021</results_first_submitted>
  <results_first_submitted_qc>June 15, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">July 7, 2021</results_first_posted>
  <last_update_submitted>June 15, 2021</last_update_submitted>
  <last_update_submitted_qc>June 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chronic Kidney Disease (CKD)</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>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dapagliflozin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 17, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/50/NCT03036150/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>April 15, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/50/NCT03036150/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Dapagliflozin</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="2152"/>
                <participants group_id="P2" count="2152"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2142"/>
                <participants group_id="P2" count="2147"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Dapagliflozin</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="2152"/>
            <count group_id="B2" value="2152"/>
            <count group_id="B3" value="4304"/>
          </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="61.8" spread="12.1"/>
                    <measurement group_id="B2" value="61.9" spread="12.1"/>
                    <measurement group_id="B3" value="61.8" spread="12.1"/>
                  </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 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="362"/>
                    <measurement group_id="B2" value="370"/>
                    <measurement group_id="B3" value="732"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt; 50 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1790"/>
                    <measurement group_id="B2" value="1782"/>
                    <measurement group_id="B3" value="3572"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;= 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1247"/>
                    <measurement group_id="B2" value="1239"/>
                    <measurement group_id="B3" value="2486"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt; 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="905"/>
                    <measurement group_id="B2" value="913"/>
                    <measurement group_id="B3" value="1818"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1247"/>
                    <measurement group_id="B2" value="1239"/>
                    <measurement group_id="B3" value="2486"/>
                  </measurement_list>
                </category>
                <category>
                  <title>66-75 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="663"/>
                    <measurement group_id="B2" value="667"/>
                    <measurement group_id="B3" value="1330"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt; 75 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="242"/>
                    <measurement group_id="B2" value="246"/>
                    <measurement group_id="B3" value="488"/>
                  </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="709"/>
                    <measurement group_id="B2" value="716"/>
                    <measurement group_id="B3" value="1425"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1443"/>
                    <measurement group_id="B2" value="1436"/>
                    <measurement group_id="B3" value="2879"/>
                  </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="522"/>
                    <measurement group_id="B2" value="550"/>
                    <measurement group_id="B3" value="1072"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1630"/>
                    <measurement group_id="B2" value="1602"/>
                    <measurement group_id="B3" value="3232"/>
                  </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="1124"/>
                    <measurement group_id="B2" value="1166"/>
                    <measurement group_id="B3" value="2290"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="104"/>
                    <measurement group_id="B2" value="87"/>
                    <measurement group_id="B3" value="191"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="749"/>
                    <measurement group_id="B2" value="718"/>
                    <measurement group_id="B3" value="1467"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="62"/>
                    <measurement group_id="B2" value="74"/>
                    <measurement group_id="B3" value="136"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="112"/>
                    <measurement group_id="B2" value="106"/>
                    <measurement group_id="B3" value="218"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Most likely etiology of CKD</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Diabetic Nephropathy</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1271"/>
                    <measurement group_id="B2" value="1239"/>
                    <measurement group_id="B3" value="2510"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Ischaemic/Hypertensive Nephropathy</title>
                  <measurement_list>
                    <measurement group_id="B1" value="324"/>
                    <measurement group_id="B2" value="363"/>
                    <measurement group_id="B3" value="687"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Chronic Glomerulonephritis</title>
                  <measurement_list>
                    <measurement group_id="B1" value="343"/>
                    <measurement group_id="B2" value="352"/>
                    <measurement group_id="B3" value="695"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other or unknown cause of CKD</title>
                  <measurement_list>
                    <measurement group_id="B1" value="214"/>
                    <measurement group_id="B2" value="198"/>
                    <measurement group_id="B3" value="412"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>eGFR</title>
          <units>mL/min/1.73 m2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="43.2" spread="12.3"/>
                    <measurement group_id="B2" value="43.0" spread="12.4"/>
                    <measurement group_id="B3" value="43.1" spread="12.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Urine albumin creatinine ratio</title>
          <units>mg/g</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="965" lower_limit="472" upper_limit="1903"/>
                    <measurement group_id="B2" value="934" lower_limit="482" upper_limit="1869"/>
                    <measurement group_id="B3" value="949" lower_limit="477" upper_limit="1865"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Type 2 Diabetes Mellitus 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="1455"/>
                    <measurement group_id="B2" value="1451"/>
                    <measurement group_id="B3" value="2906"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="697"/>
                    <measurement group_id="B2" value="701"/>
                    <measurement group_id="B3" value="1398"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Time to the First Occurrence of Any of the Components of the Composite: ≥50% Sustained Decline in eGFR or Reaching ESRD or CV Death or Renal Death.</title>
        <description>End Stage Renal Disease (ESRD) is defined as:&#xD;
Sustained eGFR &lt;15 mL/min/1.73m2 or,&#xD;
Chronic dialysis treatment or,&#xD;
Receiving a renal transplant The proportional hazards Cox regression model takes into account the time to the event. Data is reported as the numbers of subjects with the event and the Hazard ratio is included in the Statistical Analysis section attached to the Outcome Measure data table.</description>
        <time_frame>Up to 38.2 months</time_frame>
        <population>For the primary endpoint the Full Analysis Set was used. This included all patients who were randomized to study treatment. Patients were analyzed according to their randomized treatment assignment.</population>
        <group_list>
          <group group_id="O1">
            <title>Dapagliflozin</title>
            <description>Dapagliflozin 10 mg, given once daily per oral use</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>Time to the First Occurrence of Any of the Components of the Composite: ≥50% Sustained Decline in eGFR or Reaching ESRD or CV Death or Renal Death.</title>
          <description>End Stage Renal Disease (ESRD) is defined as:&#xD;
Sustained eGFR &lt;15 mL/min/1.73m2 or,&#xD;
Chronic dialysis treatment or,&#xD;
Receiving a renal transplant The proportional hazards Cox regression model takes into account the time to the event. Data is reported as the numbers of subjects with the event and the Hazard ratio is included in the Statistical Analysis section attached to the Outcome Measure data table.</description>
          <population>For the primary endpoint the Full Analysis Set was used. This included all patients who were randomized to study treatment. Patients were analyzed according to their randomized treatment assignment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2152"/>
                <count group_id="O2" value="2152"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="197"/>
                    <measurement group_id="O2" value="312"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.0001</p_value>
            <method>Regression, Cox</method>
            <method_desc>Stratified by randomization stratification of Type 2 Diabetes and urine albumin creatinine ratio and adjusting for baseline eGFR.</method_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.61</param_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>0.51</ci_lower_limit>
            <ci_upper_limit>0.72</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to the First Occurrence of Any of the Components of the Composite: ≥50% Sustained Decline in eGFR or Reaching ESRD or Renal Death.</title>
        <description>End Stage Renal Disease (ESRD) is defined as:&#xD;
Sustained eGFR &lt;15 mL/min/1.73m2 or,&#xD;
Chronic dialysis treatment or,&#xD;
Receiving a renal transplant The proportional hazards Cox regression model takes into account the time to the event. Data is reported as the numbers of subjects with the event and the Hazard ratio is included in the Statistical Analysis section attached to the Outcome Measure data table.</description>
        <time_frame>Up to 38.2 months</time_frame>
        <population>For the secondary endpoints the Full Analysis Set was used. This included all patients who were randomized to study treatment. Patients were analyzed according to their randomized treatment assignment.</population>
        <group_list>
          <group group_id="O1">
            <title>Dapagliflozin</title>
            <description>Dapagliflozin 10 mg, given once daily per oral use</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>Time to the First Occurrence of Any of the Components of the Composite: ≥50% Sustained Decline in eGFR or Reaching ESRD or Renal Death.</title>
          <description>End Stage Renal Disease (ESRD) is defined as:&#xD;
Sustained eGFR &lt;15 mL/min/1.73m2 or,&#xD;
Chronic dialysis treatment or,&#xD;
Receiving a renal transplant The proportional hazards Cox regression model takes into account the time to the event. Data is reported as the numbers of subjects with the event and the Hazard ratio is included in the Statistical Analysis section attached to the Outcome Measure data table.</description>
          <population>For the secondary endpoints the Full Analysis Set was used. This included all patients who were randomized to study treatment. Patients were analyzed according to their randomized treatment assignment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2152"/>
                <count group_id="O2" value="2152"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="142"/>
                    <measurement group_id="O2" value="243"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.0001</p_value>
            <method>Regression, Cox</method>
            <method_desc>Stratified by randomization stratification of Type 2 Diabetes and urine albumin creatinine ratio and adjusting for baseline eGFR.</method_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.56</param_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>0.45</ci_lower_limit>
            <ci_upper_limit>0.68</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to the First Occurrence of Either of the Components of the Composite: CV Death or Hospitalization for Heart Failure.</title>
        <description>The proportional hazards Cox regression model takes into account the time to the event. Data is reported as the numbers of subjects with the event and the Hazard ratio is included in the Statistical Analysis section attached to the Outcome Measure data table.</description>
        <time_frame>Up to 38.2 months</time_frame>
        <population>For the secondary endpoints the Full Analysis Set was used. This included all patients who were randomized to study treatment. Patients were analyzed according to their randomized treatment assignment.</population>
        <group_list>
          <group group_id="O1">
            <title>Dapagliflozin</title>
            <description>Dapagliflozin 10 mg, given once daily per oral use</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>Time to the First Occurrence of Either of the Components of the Composite: CV Death or Hospitalization for Heart Failure.</title>
          <description>The proportional hazards Cox regression model takes into account the time to the event. Data is reported as the numbers of subjects with the event and the Hazard ratio is included in the Statistical Analysis section attached to the Outcome Measure data table.</description>
          <population>For the secondary endpoints the Full Analysis Set was used. This included all patients who were randomized to study treatment. Patients were analyzed according to their randomized treatment assignment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2152"/>
                <count group_id="O2" value="2152"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="138"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0089</p_value>
            <method>Regression, Cox</method>
            <method_desc>Stratified by randomization stratification of Type 2 Diabetes and urine albumin creatinine ratio and adjusting for baseline eGFR.</method_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.71</param_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>0.55</ci_lower_limit>
            <ci_upper_limit>0.92</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Death From Any Cause.</title>
        <description>The proportional hazards Cox regression model takes into account the time to the event. Data is reported as the numbers of subjects with the event and the Hazard ratio is included in the Statistical Analysis section attached to the Outcome Measure data table.</description>
        <time_frame>Up to 38.2 months</time_frame>
        <population>For the secondary endpoints the Full Analysis Set was used. This included all patients who were randomized to study treatment. Patients were analyzed according to their randomized treatment assignment.</population>
        <group_list>
          <group group_id="O1">
            <title>Dapagliflozin</title>
            <description>Dapagliflozin 10 mg, given once daily per oral use</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>Time to Death From Any Cause.</title>
          <description>The proportional hazards Cox regression model takes into account the time to the event. Data is reported as the numbers of subjects with the event and the Hazard ratio is included in the Statistical Analysis section attached to the Outcome Measure data table.</description>
          <population>For the secondary endpoints the Full Analysis Set was used. This included all patients who were randomized to study treatment. Patients were analyzed according to their randomized treatment assignment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2152"/>
                <count group_id="O2" value="2152"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="101"/>
                    <measurement group_id="O2" value="146"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0035</p_value>
            <method>Regression, Cox</method>
            <method_desc>Stratified by randomization stratification of Type 2 Diabetes and urine albumin creatinine ratio and adjusting for baseline eGFR.</method_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.69</param_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>0.53</ci_lower_limit>
            <ci_upper_limit>0.88</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 39.2 months</time_frame>
      <desc>For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was 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 10 mg</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 23.0</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="107" subjects_at_risk="2152"/>
                <counts group_id="E2" subjects_affected="159" subjects_at_risk="2152"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="633" subjects_at_risk="2149"/>
                <counts group_id="E2" subjects_affected="729" subjects_at_risk="2149"/>
              </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="8" subjects_affected="7" subjects_at_risk="2149"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Blood loss anaemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2149"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Bone marrow failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Hypochromic anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Iron deficiency anaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Nephrogenic anaemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute coronary syndrome</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Acute left ventricular failure</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="2149"/>
                <counts group_id="E2" events="12" subjects_affected="10" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="35" subjects_affected="32" subjects_at_risk="2149"/>
                <counts group_id="E2" events="56" subjects_affected="46" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="2149"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" events="17" subjects_affected="14" subjects_at_risk="2149"/>
                <counts group_id="E2" events="26" subjects_affected="22" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Aortic valve disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Aortic valve incompetence</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Arteriosclerosis coronary artery</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="2149"/>
                <counts group_id="E2" events="18" subjects_affected="17" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Atrioventricular block</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Atrioventricular block complete</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2149"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Atrioventricular block second degree</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Bradyarrhythmia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2149"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Bundle branch block left</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="2149"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" events="56" subjects_affected="39" subjects_at_risk="2149"/>
                <counts group_id="E2" events="72" subjects_affected="59" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Cardiac failure acute</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="2149"/>
                <counts group_id="E2" events="8" subjects_affected="7" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Cardiac failure chronic</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="2149"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" events="17" subjects_affected="13" subjects_at_risk="2149"/>
                <counts group_id="E2" events="29" subjects_affected="22" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Cardio-respiratory arrest</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="2149"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Cardiogenic shock</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Cardiomyopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Cardiopulmonary failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Cardiorenal syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Chronic left ventricular failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Congestive cardiomyopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="2149"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Coronary artery stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Defect conduction intraventricular</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Hypertensive heart disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="5" subjects_affected="3" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Ischaemic cardiomyopathy</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="2149"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Left ventricular dysfunction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Left ventricular failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Mitral valve incompetence</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="2149"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Myocardial ischaemia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="2149"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Pericardial effusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Pericarditis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Prinzmetal angina</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Sinus bradycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Supraventricular tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Ventricular hypokinesia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Ventricular tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertrophic cardiomyopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Vestibular disorder</sub_title>
                <counts group_id="E1" events="7" subjects_affected="5" subjects_at_risk="2149"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Goitre</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Hyperadrenocorticism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Hyperparathyroidism primary</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Pituitary-dependent cushing's syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Toxic nodular goitre</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" events="12" subjects_affected="8" subjects_at_risk="2149"/>
                <counts group_id="E2" events="8" subjects_affected="6" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Cataract subcapsular</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Diabetic retinal oedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Diabetic retinopathy</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Diplopia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Glaucoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Ocular hyperaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Ocular ischaemic syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Retinal detachment</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Retinal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Vitreous disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Vitreous haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal hernia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Abdominal hernia obstructive</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2149"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Abdominal wall haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Colitis ischaemic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Diabetic gastroparesis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Diverticular perforation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Diverticulum</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Diverticulum intestinal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Diverticulum intestinal haemorrhagic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Duodenal ulcer</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Duodenal ulcer perforation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Enteritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Enterocolitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Erosive oesophagitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Faecaloma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Food poisoning</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Gastric disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Gastric ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Gastric ulcer haemorrhage</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2149"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Gastritis hypertrophic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Gastroduodenal ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Gastrointestinal angiectasia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Gastrointestinal disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="2149"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Gastrointestinal motility disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Gastrointestinal polyp haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Gastrointestinal ulcer haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Haemoperitoneum</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Haemorrhoidal haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Impaired gastric emptying</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Inguinal hernia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Large intestine polyp</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Lower gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Mechanical ileus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Mesenteric artery thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Mesenteric vascular insufficiency</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Mesenteric vein thrombosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Obstruction gastric</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Obstructive pancreatitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Oesophageal stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Oesophageal ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Palatal disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Pancreatic cyst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Pancreatitis acute</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Pancreatitis chronic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Pancreatitis relapsing</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Peptic ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Small intestinal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Thrombosis mesenteric vessel</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Upper gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Varices oesophageal</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </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="2149"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Cardiac death</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Catheter site haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2149"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" events="15" subjects_affected="15" subjects_at_risk="2149"/>
                <counts group_id="E2" events="27" subjects_affected="27" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Gait disturbance</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Generalised oedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Impaired healing</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Inflammation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Medical device site discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Medical device site pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Multiple organ dysfunction syndrome</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2149"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2149"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Stent-graft endoleak</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Sudden cardiac death</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Sudden death</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Systemic inflammatory response syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Bile duct obstruction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Bile duct stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Bile duct stone</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Biliary colic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Cholangitis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="2149"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Cholangitis acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2149"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Cholecystitis chronic</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Cirrhosis alcoholic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Hepatic cirrhosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2149"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Hepatic failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Hepatotoxicity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Liver injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Sarcoidosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Transplant rejection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Abscess limb</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Acquired immunodeficiency syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Acute hepatitis b</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Anal abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2149"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Appendicitis perforated</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Arthritis bacterial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Arthritis infective</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Bacterial sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Biliary sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="2149"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Bronchitis bacterial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Bronchitis viral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Bronchopulmonary aspergillosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Covid-19</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Covid-19 pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Candida infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="17" subjects_affected="14" subjects_at_risk="2149"/>
                <counts group_id="E2" events="20" subjects_affected="15" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Cellulitis gangrenous</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Cholecystitis infective</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Clostridium difficile colitis</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Clostridium difficile infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Coronavirus infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Cytomegalovirus infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Dengue fever</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Dengue haemorrhagic fever</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Device related infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Device related sepsis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Diabetic foot infection</sub_title>
                <counts group_id="E1" events="8" subjects_affected="5" subjects_at_risk="2149"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Diabetic gangrene</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="2149"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Empyema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Encephalitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Endocarditis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Erysipelas</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2149"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Escherichia bacteraemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Escherichia sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Escherichia urinary tract infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Fournier's gangrene</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Fungaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Fungal oesophagitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Furuncle</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Gangrene</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="2149"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Gas gangrene</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="11" subjects_affected="10" subjects_at_risk="2149"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Gastroenteritis salmonella</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Gastrointestinal bacterial infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Gastrointestinal infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Infected skin ulcer</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="2149"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Infectious pleural effusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Infective exacerbation of chronic obstructive airways disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="2149"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Inguinal hernia gangrenous</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Intestinal sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Large intestine infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Leishmaniasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Liver abscess</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Localised infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2149"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Mastoiditis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Mediastinitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Meningitis bacterial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Meningoencephalitis herpetic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Necrotising fasciitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Osteomyelitis</sub_title>
                <counts group_id="E1" events="12" subjects_affected="10" subjects_at_risk="2149"/>
                <counts group_id="E2" events="13" subjects_affected="12" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Osteomyelitis chronic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Otitis externa</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Otitis media</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Peritonitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Peritonsillar abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Pilonidal cyst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Plasmodium falciparum infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Pneumocystis jirovecii pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="50" subjects_affected="44" subjects_at_risk="2149"/>
                <counts group_id="E2" events="79" subjects_affected="70" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Pneumonia bacterial</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Pneumonia fungal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Pneumonia haemophilus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Pneumonia influenzal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Pneumonia legionella</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Post procedural infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Postoperative wound infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2149"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Pulmonary sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Pyelonephritis acute</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Pyonephrosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Rocky mountain spotted fever</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="13" subjects_affected="13" subjects_at_risk="2149"/>
                <counts group_id="E2" events="18" subjects_affected="18" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="2149"/>
                <counts group_id="E2" events="11" subjects_affected="11" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Soft tissue infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Splenic abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Staphylococcal bacteraemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Staphylococcal sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Streptococcal bacteraemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Streptococcal endocarditis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Subcutaneous abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Superinfection viral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Suspected covid-19</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Tonsillitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Tooth abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Tuberculosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Tuberculosis bladder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="22" subjects_affected="20" subjects_at_risk="2149"/>
                <counts group_id="E2" events="21" subjects_affected="15" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Urinary tract infection bacterial</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Urogenital infection bacterial</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="2149"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Varicella zoster virus infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Vestibular neuronitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Vulval cellulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Wound infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Accidental overdose</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Ankle fracture</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Arteriovenous fistula site haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Arteriovenous fistula thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Arteriovenous graft aneurysm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Burns third degree</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Carbon monoxide poisoning</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Cervical vertebral fracture</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Chest injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Concussion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Craniocerebral injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Femoral neck fracture</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2149"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="2149"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Foot fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Forearm fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Foreign body aspiration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Hand fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Head injury</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2149"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Hip fracture</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Humerus fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Inflammation of wound</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Injury</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Joint dislocation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Joint injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Lenticular injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Ligament rupture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Limb injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Limb traumatic amputation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Lower limb fracture</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Meniscus injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Multiple fractures</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Multiple injuries</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Muscle strain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Patella fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Pelvic fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Periprosthetic fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Post procedural bile leak</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Post procedural complication</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Post procedural fever</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Post procedural haematoma</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Post procedural haematuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Post procedural haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Radiation proctitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Radius fracture</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Road traffic accident</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Scapula fracture</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Skin laceration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Soft tissue injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Spinal column injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Spinal compression fracture</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Spinal fracture</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Subdural haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Tendon injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Tendon rupture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Thermal burn</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Tibia fracture</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Toxicity to various agents</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Traumatic arthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Traumatic haemothorax</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Traumatic intracranial haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Upper limb fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Vascular access malfunction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Vascular pseudoaneurysm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Wound evisceration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Wrist fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Blood glucose increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Blood parathyroid hormone increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Fibrin d dimer increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Glomerular filtration rate decreased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2149"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Hepatic enzyme increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Oxygen saturation decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Acidosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Cachexia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2149"/>
                <counts group_id="E2" events="9" subjects_affected="7" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Diabetes mellitus</sub_title>
                <counts group_id="E1" events="11" subjects_affected="9" subjects_at_risk="2149"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Diabetes mellitus inadequate control</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2149"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Diabetic ketoacidosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Diabetic metabolic decompensation</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="2149"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Electrolyte imbalance</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Fluid overload</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2149"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Gout</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="8" subjects_affected="6" subjects_at_risk="2149"/>
                <counts group_id="E2" events="19" subjects_affected="17" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Hyperglycaemic hyperosmolar nonketotic syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Hyperinsulinaemic hypoglycaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="2149"/>
                <counts group_id="E2" events="12" subjects_affected="12" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Hypocalcaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="2149"/>
                <counts group_id="E2" events="19" subjects_affected="18" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Hypophagia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Hypovolaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Lactic acidosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Metabolic acidosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Metabolic disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Milk-alkali syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Obesity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Shock hypoglycaemic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Type 2 diabetes mellitus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </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="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Arthropathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Bursitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Facet joint syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Fracture nonunion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Gouty arthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Intervertebral disc compression</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Intervertebral disc disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Intervertebral disc protrusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Lumbar spinal stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Neuropathic arthropathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="2149"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Osteochondrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Osteolysis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Osteonecrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Polymyalgia rheumatica</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Rhabdomyolysis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Rotator cuff syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Spinal osteoarthritis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Spinal stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Systemic lupus erythematosus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Acute myeloid leukaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Adenocarcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Adenocarcinoma gastric</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Adenocarcinoma of colon</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Adenocarcinoma pancreas</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Adrenal adenoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>B-cell lymphoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2149"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Benign biliary neoplasm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Bile duct cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Bladder cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Bone giant cell tumour malignant</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Breast cancer female</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Bronchial carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Cancer pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Cholangiocarcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Clear cell renal cell carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Colon adenoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Colon cancer</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Colon cancer metastatic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Craniopharyngioma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Diffuse large b-cell lymphoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Endometrial adenocarcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Endometrial cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Endometrial cancer stage i</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Epithelioid mesothelioma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Gallbladder cancer metastatic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Gastric adenoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Gastric cancer</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Hepatic cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Hepatic cancer metastatic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Hepatocellular carcinoma</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Intraductal papillary mucinous neoplasm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Laryngeal cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Lip and/or oral cavity cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Lung adenocarcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Lung carcinoma cell type unspecified recurrent</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Lung neoplasm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Lung neoplasm malignant</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2149"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Lymphoplasmacytoid lymphoma/immunocytoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Malignant peritoneal neoplasm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Malignant pleural effusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Mantle cell lymphoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Metastases to bladder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Metastases to liver</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Neoplasm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Neoplasm skin</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Non-small cell lung cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Ovarian cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Pancreatic carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Pancreatic carcinoma metastatic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Pancreatic neoplasm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Papillary renal cell carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Peripheral t-cell lymphoma unspecified recurrent</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Plasma cell myeloma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Prostate cancer</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="2149"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Prostate cancer metastatic</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Prostate cancer stage ii</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Prostatic adenoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Rectal adenocarcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Rectal cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Rectosigmoid cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Renal cancer</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Renal cell carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Renal cell carcinoma stage iv</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Renal hamartoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Renal neoplasm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Salivary gland adenoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Schwannoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Small cell lung cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Soft tissue neoplasm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma of skin</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Testicular germ cell cancer metastatic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Transitional cell carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Uterine leiomyoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Vaginal cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Vocal cord neoplasm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Altered state of consciousness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Basal ganglia haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Brain hypoxia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Brain injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Brain oedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Brain stem haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Brain stem infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Brain stem stroke</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Carotid arteriosclerosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Carotid artery aneurysm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Carotid artery occlusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Carotid artery stenosis</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Carpal tunnel syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Cerebellar stroke</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Cerebral haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="2149"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Cerebral ischaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Cerebral vasoconstriction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="2149"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Cerebrovascular disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Dementia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Diabetic hyperosmolar coma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Dysarthria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Embolic stroke</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Encephalopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Epilepsy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Facial nerve disorder</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Facial paralysis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Guillain-barre syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Haemorrhage intracranial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Haemorrhagic stroke</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Hemiparesis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Hepatic encephalopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Intracranial aneurysm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Intraventricular haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Ischaemic cerebral infarction</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Ischaemic stroke</sub_title>
                <counts group_id="E1" events="23" subjects_affected="22" subjects_at_risk="2149"/>
                <counts group_id="E2" events="29" subjects_affected="28" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Lacunar stroke</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Lumbar radiculopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Lumbosacral radiculopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Metabolic encephalopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Motor neurone disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Multiple sclerosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Neuropathy peripheral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Normal pressure hydrocephalus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Partial seizures</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Putamen haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Radiculopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Subarachnoid haemorrhage</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="2149"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Tension headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Thalamic infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Toxic encephalopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="2149"/>
                <counts group_id="E2" events="10" subjects_affected="9" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Vascular encephalopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Abortion spontaneous</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Anembryonic gestation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Pre-eclampsia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Premature separation of placenta</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </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="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Device malfunction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Device power source issue</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Completed suicide</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Hallucination, visual</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Post stroke depression</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Sleep disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Suicidal ideation</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Suicide attempt</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </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="43" subjects_affected="39" subjects_at_risk="2149"/>
                <counts group_id="E2" events="64" subjects_affected="52" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Bladder tamponade</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Chronic kidney disease</sub_title>
                <counts group_id="E1" events="24" subjects_affected="20" subjects_at_risk="2149"/>
                <counts group_id="E2" events="34" subjects_affected="31" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Cystitis haemorrhagic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Diabetic nephropathy</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2149"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>End stage renal disease</sub_title>
                <counts group_id="E1" events="27" subjects_affected="26" subjects_at_risk="2149"/>
                <counts group_id="E2" events="39" subjects_affected="36" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Focal segmental glomerulosclerosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Glomerulonephritis chronic</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="2149"/>
                <counts group_id="E2" events="9" subjects_affected="6" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Glomerulonephritis rapidly progressive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="6" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Hydronephrosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Iga nephropathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Intercapillary glomerulosclerosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Nephropathy</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2149"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Nephropathy toxic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Nephrosclerosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Nephrotic syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="5" subjects_affected="3" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Obstructive nephropathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Prerenal failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Renal amyloidosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Renal colic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="2149"/>
                <counts group_id="E2" events="11" subjects_affected="10" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Renal impairment</sub_title>
                <counts group_id="E1" events="15" subjects_affected="14" subjects_at_risk="2149"/>
                <counts group_id="E2" events="15" subjects_affected="15" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Renal mass</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Tubulointerstitial nephritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Urate nephropathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="3" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Ureteric stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Ureterolithiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Urethral dilatation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Urethral stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Urinary incontinence</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Urinary tract obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Vesical fistula</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Balanoposthitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Benign prostatic hyperplasia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="2149"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Endometrial disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Menometrorrhagia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Prostatomegaly</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Seminal vesicular cyst</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Uterine haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Uterine polyp</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="2149"/>
              </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="4" subjects_affected="4" subjects_at_risk="2149"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" events="14" subjects_affected="12" subjects_at_risk="2149"/>
                <counts group_id="E2" events="12" subjects_affected="11" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Atelectasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="2149"/>
                <counts group_id="E2" events="13" subjects_affected="10" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Dyspnoea exertional</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Haemothorax</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Laryngeal oedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Nasal polyps</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Nasal septum deviation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Obstructive airways disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="6" subjects_affected="4" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Pleurisy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Pneumonia aspiration</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Pulmonary congestion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="2149"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Pulmonary fibrosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Pulmonary oedema</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="2149"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Respiratory disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2149"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Sleep apnoea syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Angioedema</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2149"/>
                <counts group_id="E2" events="3" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Decubitus ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Diabetic foot</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="2149"/>
                <counts group_id="E2" events="10" subjects_affected="7" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Neuropathic ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Pyoderma gangrenosum</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Skin ulcer</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2149"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="2149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Aortic aneurysm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Aortic aneurysm rupture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Aortic dissection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Aortic stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Arterial occlusive disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Arteriosclerosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="2149"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Diabetic vascular disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Dry gangrene</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Extremity necrosis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Femoral artery embolism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Granulomatosis with polyangiitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="13" subjects_affected="9" subjects_at_risk="2149"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Hypertensive crisis</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="2149"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Hypertensive emergency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Hypertensive urgency</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="2149"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Hypovolaemic shock</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Iliac artery embolism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Iliac artery stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Orthostatic hypotension</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Peripheral arterial occlusive disease</sub_title>
                <counts group_id="E1" events="8" subjects_affected="6" subjects_at_risk="2149"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Peripheral artery occlusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Peripheral artery stenosis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Peripheral artery thrombosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Peripheral ischaemia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="2149"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Peripheral vascular disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Shock haemorrhagic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Thrombophlebitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Venous thrombosis limb</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2149"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2</frequency_threshold>
        <default_vocab>MedDRA 23.0</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="479" subjects_at_risk="2149"/>
                <counts group_id="E2" subjects_affected="500" subjects_at_risk="2149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="56" subjects_affected="45" subjects_at_risk="2149"/>
                <counts group_id="E2" events="46" subjects_affected="41" subjects_at_risk="2149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="56" subjects_affected="54" subjects_at_risk="2149"/>
                <counts group_id="E2" events="75" subjects_affected="63" subjects_at_risk="2149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="136" subjects_affected="92" subjects_at_risk="2149"/>
                <counts group_id="E2" events="118" subjects_affected="81" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="102" subjects_affected="78" subjects_at_risk="2149"/>
                <counts group_id="E2" events="96" subjects_affected="79" subjects_at_risk="2149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Glomerular filtration rate decreased</sub_title>
                <counts group_id="E1" events="45" subjects_affected="39" subjects_at_risk="2149"/>
                <counts group_id="E2" events="67" subjects_affected="61" subjects_at_risk="2149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" events="67" subjects_affected="53" subjects_at_risk="2149"/>
                <counts group_id="E2" events="54" subjects_affected="49" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" events="119" subjects_affected="74" subjects_at_risk="2149"/>
                <counts group_id="E2" events="96" subjects_affected="70" subjects_at_risk="2149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="46" subjects_affected="44" subjects_at_risk="2149"/>
                <counts group_id="E2" events="52" subjects_affected="50" subjects_at_risk="2149"/>
              </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="54" subjects_affected="49" subjects_at_risk="2149"/>
                <counts group_id="E2" events="50" subjects_affected="44" subjects_at_risk="2149"/>
              </event>
              <event>
                <sub_title>Renal impairment</sub_title>
                <counts group_id="E1" events="55" subjects_affected="51" subjects_at_risk="2149"/>
                <counts group_id="E2" events="72" subjects_affected="64" subjects_at_risk="2149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="63" subjects_affected="62" subjects_at_risk="2149"/>
                <counts group_id="E2" events="66" subjects_affected="60" subjects_at_risk="2149"/>
              </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/NCT03036150
org study id: D169AC00001
secondary id: 2016-003896-24
nct id: NCT03036150
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 renal outcomes and
      cardiovascular mortality in patients with chronic kidney disease.
This is an international, multicentre, event-driven, randomized, double-blind, parallel
      group, placebo-controlled study, evaluating the effect of dapagliflozin versus placebo, given
      once daily in addition to standard of care, to prevent the progression of chronic kidney
      disease (CKD) or cardiovascular (CV)/renal death.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Time to the First Occurrence of Any of the Components of the Composite: ≥50% Sustained Decline in eGFR or Reaching ESRD or CV Death or Renal Death.
time frame: Up to 38.2 months
description: End Stage Renal Disease (ESRD) is defined as:
Sustained eGFR <15 mL/min/1.73m2 or,
Chronic dialysis treatment or,
Receiving a renal transplant The proportional hazards Cox regression model takes into account the time to the event. Data is reported as the numbers of subjects with the event and the Hazard ratio is included in the Statistical Analysis section attached to the Outcome Measure data table.
measure: Time to the First Occurrence of Any of the Components of the Composite: ≥50% Sustained Decline in eGFR or Reaching ESRD or Renal Death.
time frame: Up to 38.2 months
description: End Stage Renal Disease (ESRD) is defined as:
Sustained eGFR <15 mL/min/1.73m2 or,
Chronic dialysis treatment or,
Receiving a renal transplant The proportional hazards Cox regression model takes into account the time to the event. Data is reported as the numbers of subjects with the event and the Hazard ratio is included in the Statistical Analysis section attached to the Outcome Measure data table.
measure: Time to the First Occurrence of Either of the Components of the Composite: CV Death or Hospitalization for Heart Failure.
time frame: Up to 38.2 months
description: The proportional hazards Cox regression model takes into account the time to the event. Data is reported as the numbers of subjects with the event and the Hazard ratio is included in the Statistical Analysis section attached to the Outcome Measure data table.
measure: Time to Death From Any Cause.
time frame: Up to 38.2 months
description: The proportional hazards Cox regression model takes into account the time to the event. Data is reported as the numbers of subjects with the event and the Hazard ratio is included in the Statistical Analysis section attached to the Outcome Measure data table.
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: Canada
country: China
country: Denmark
country: Germany
country: Hungary
country: India
country: Japan
country: Korea, Republic of
country: Mexico
country: Peru
country: Philippines
country: Poland
country: Russian Federation
country: Spain
country: Sweden
country: Ukraine
country: United Kingdom
country: United States
country: Vietnam
url: https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=D169AC00001&amp;attachmentIdentifier=c59c2c03-ebfa-46f4-beac-d0b14b62db99&amp;fileName=d169ac00001_csp_Redacted.pdf&amp;versionIdentifier=
description: redacted protocol
url: https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=D169AC00001&amp;attachmentIdentifier=987ded9e-acd7-4718-a380-431a2b2d1377&amp;fileName=d169ac00001_sap_Redacted.pdf&amp;versionIdentifier=
description: redacted Statistical Analysis Plan
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
mesh term: Dapagliflozin
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 