<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/NCT02251275</url>
  </required_header>
  <id_info>
    <org_study_id>156-13-211</org_study_id>
    <nct_id>NCT02251275</nct_id>
  </id_info>
  <brief_title>Long Term Safety of Immediate-release Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease</brief_title>
  <official_title>A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Immediate-release Tolvaptan (OPC-41061, 30 mg to 120 mg/Day, Split Dose) in Subjects With Autosomal Dominant Polycystic Kidney Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Otsuka Pharmaceutical Development &amp; Commercialization, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Otsuka Pharmaceutical Development &amp; Commercialization, Inc.</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 the trial was to evaluate and describe the long term safety of tolvaptan in&#xD;
      participants with autosomal dominant polycystic kidney disease (ADPKD).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This was a Phase 3b trial to evaluate and describe the long term safety of tolvaptan&#xD;
      treatment in ADPKD participants with chronic kidney disease (CKD). Eligible participants&#xD;
      could enroll into Trial 156-13-211 after completing the follow-up visit(s) of their previous&#xD;
      trial (156-13-210, 156-08-271, 156-04-251, or 156-09-290). Renal function was assessed during&#xD;
      screening by using historical laboratory values for serum creatinine levels to calculate the&#xD;
      estimated glomerular filtration rate (eGFR).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 17, 2014</start_date>
  <completion_date type="Actual">November 9, 2018</completion_date>
  <primary_completion_date type="Actual">November 9, 2018</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number Of Participants Reporting Treatment-Emergent Adverse Events (TEAEs)</measure>
    <time_frame>Baseline through end of treatment (up to 42 months) and follow-up 7 days posttreatment(+ 7 days)</time_frame>
    <description>An adverse event (AE) was as any untoward medical occurrence associated with the use of an investigational medicinal product (IMP), whether or not considered IMP related. A TEAE was an AE that started after trial drug treatment; or if the event was continuous from baseline and was serious, related to IMP, or resulted in death, discontinuation, interruption or reduction of trial therapy. A serious TEAE included any event that resulted in: death, life-threatening, persistent or significant incapacity, substantial disruption of ability to conduct normal life functions, required inpatient hospitalization, prolonged hospitalization, congenital anomaly/birth defect, or other medically significant events as per medical judgment, that jeopardized the participant and that required medical or surgical intervention. A severe TEAE was an inability to work or perform normal daily activity. A summary of serious and all other non-serious TEAEs, regardless of causality, is located in the AE section.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">1803</enrollment>
  <condition>Polycystic Kidney, Autosomal Dominant</condition>
  <arm_group>
    <arm_group_label>Tolvaptan</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tolvaptan was self-administered orally as split-dose regimens. The dose regimens used in this trial were 15/15 milligram (mg), 30/15 mg, 45/15 mg, 60/30 mg, or 90/30 mg. Starting doses were dependent upon the participant's previous trial as follows:&#xD;
Trial 156-13-210: initiated on tolvaptan at a split-dose of 45/15 mg with upward titration every 3 to 4 days to 60/30 mg or 90/30 mg per day according to tolerability.&#xD;
Trial 156-08-271: retained the last dose level of tolvaptan received in the trial (45/15 mg, 60/30 mg, or 90/30 mg) and started at that same dose in Trial 156-13-211.&#xD;
Other Trials (156-04-251 and 156-09-290): initiated on tolvaptan at a split-dose of 45/15 mg with upward titration every 3 to 4 days to 60/30 mg or 90/30 mg per day according to tolerability.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tolvaptan</intervention_name>
    <description>Tolvaptan tablets (15 or 30 mg) self-administered orally as split-dose regimens, once upon awakening and another approximately 8 to 9 hours later</description>
    <arm_group_label>Tolvaptan</arm_group_label>
    <other_name>OPC-41061</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female participants ≥ 18 years with confirmed diagnosis of ADPKD (during&#xD;
             participation in prior tolvaptan trials) who have completed and transferred from the&#xD;
             double-blind Trial 156-13-210 (12-month period including post treatment follow-up,&#xD;
             regardless of whether this was on-treatment or off-treatment), or completed Trial&#xD;
             156-08-271 or a prior tolvaptan trial, or interrupted or discontinued treatment in a&#xD;
             prior tolvaptan ADPKD trial other than Trial 156-13-210. Participants may be enrolled&#xD;
             with the medical monitor approval, and additional close monitoring may be required at&#xD;
             the beginning of the trial.&#xD;
&#xD;
          -  eGFR ≥ 20 milliliter (mL)/minute (min)/1.73 meter squared (m^2) within 3 months prior&#xD;
             to the baseline visit. Participants who have an eGFR ≤ 20 mL/min/1.73 m^2 may be&#xD;
             enrolled with medical monitor approval.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Need for chronic diuretic use&#xD;
&#xD;
          -  Hepatic impairment based on liver function abnormalities other than that expected for&#xD;
             ADPKD with cystic liver disease&#xD;
&#xD;
          -  Women of childbearing potential who do not agree to practice 2 different methods of&#xD;
             birth control or remain abstinent during the trial and for 30 days after the last dose&#xD;
             of investigational medicinal product (IMP)&#xD;
&#xD;
          -  Women who are breast-feeding and/or who have a positive pregnancy test result prior to&#xD;
             receiving IMP.&#xD;
&#xD;
          -  Participants with contraindications to required trial assessments (contraindications&#xD;
             to optional assessments, for example, magnetic resonance imaging [MRI] are not a&#xD;
             limitation).&#xD;
&#xD;
          -  Participants who in the opinion of the investigator or the medical monitor, have a&#xD;
             medical history or medical finding inconsistent with safety or trial compliance&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Huntsville</city>
        <state>Alabama</state>
        <zip>35805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Mobile</city>
        <state>Alabama</state>
        <zip>36617</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85381</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tempe</city>
        <state>Arizona</state>
        <zip>85284</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85745</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90022</zip>
        <country>United States</country>
      </address>
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  </location>
  <location>
    <facility>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
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  </location>
  <location>
    <facility>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
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  <location>
    <facility>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
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  </location>
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      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
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      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80204</zip>
        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80210</zip>
        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06520</zip>
        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Hudson</city>
        <state>Florida</state>
        <zip>34667</zip>
        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32216</zip>
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      <address>
        <city>Miami</city>
        <state>Florida</state>
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        <state>Georgia</state>
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      <address>
        <city>Meridian</city>
        <state>Idaho</state>
        <zip>83642</zip>
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        <city>Chicago</city>
        <state>Illinois</state>
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      <address>
        <city>Chicago</city>
        <state>Illinois</state>
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      <address>
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        <state>Kansas</state>
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      <address>
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        <state>Kansas</state>
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      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70808</zip>
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      <address>
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        <country>United States</country>
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        <country>United States</country>
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      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02111</zip>
        <country>United States</country>
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        <state>Massachusetts</state>
        <zip>01107</zip>
        <country>United States</country>
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      <address>
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        <state>Michigan</state>
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        <state>Michigan</state>
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        <country>United States</country>
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        <zip>07724</zip>
        <country>United States</country>
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    <facility>
      <address>
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        <state>New Jersey</state>
        <zip>08043</zip>
        <country>United States</country>
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      <address>
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        <state>New York</state>
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        <country>United States</country>
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        <state>New York</state>
        <zip>11413</zip>
        <country>United States</country>
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        <state>New York</state>
        <zip>11501</zip>
        <country>United States</country>
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        <state>New York</state>
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        <country>United States</country>
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        <state>New York</state>
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        <country>United States</country>
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        <country>United States</country>
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        <zip>58102</zip>
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      <address>
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        <zip>44302</zip>
        <country>United States</country>
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    </facility>
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      <address>
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        <state>Ohio</state>
        <zip>45206</zip>
        <country>United States</country>
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    </facility>
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  <location>
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      <address>
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        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
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        <zip>44106</zip>
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        <state>Pennsylvania</state>
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      <address>
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        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
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    <facility>
      <address>
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        <state>South Carolina</state>
        <zip>29203</zip>
        <country>United States</country>
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      <address>
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        <zip>29118</zip>
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        <zip>37923</zip>
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        <zip>37205</zip>
        <country>United States</country>
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        <city>Yaroslavl</city>
        <zip>150062</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Pretoria</city>
        <state>Gauteng</state>
        <zip>0002</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Durban</city>
        <state>KwaZulu-Natal</state>
        <zip>4001</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cape Town</city>
        <state>Western Cape</state>
        <zip>7925</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Barcelona</city>
        <zip>08907</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ciudad Real</city>
        <zip>13005</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Valencia</city>
        <zip>46017</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Göteborg</city>
        <zip>413 45</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Linköping</city>
        <zip>58185</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Stockholm</city>
        <zip>14186</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Stockholm</city>
        <zip>17176</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Uppsala</city>
        <zip>75185</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Belfast</city>
        <state>County Antrim</state>
        <zip>BT9 7AB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Exeter</city>
        <state>Devon</state>
        <zip>EX2 5DW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hull</city>
        <state>East Riding Of Yorkshire</state>
        <zip>HU3 2JZ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Brighton</city>
        <state>East Sussex</state>
        <zip>BN2 5BE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>London</city>
        <state>Greater London</state>
        <zip>NW3 2QG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>London</city>
        <state>Greater London</state>
        <zip>SE5 9RS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>London</city>
        <state>Greater London</state>
        <zip>SW17 0QT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Manchester</city>
        <state>Greater Manchester</state>
        <zip>M13 9WL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Salford</city>
        <state>Greater Manchester</state>
        <zip>M6 8HD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Stevenage</city>
        <state>Hertfordshire</state>
        <zip>SG1 4AB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Inverness</city>
        <state>Highland Region</state>
        <zip>IV2 3UJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Leicester</city>
        <state>Leicestershire</state>
        <zip>LE5 4PW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Edinburgh</city>
        <state>Lothian Region</state>
        <zip>EH16 4SA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Liverpool</city>
        <state>Norfolk</state>
        <zip>L7 8XP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sheffield</city>
        <state>South Yorkshire</state>
        <zip>S5 7AU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Stoke on Trent</city>
        <state>Staffordshire</state>
        <zip>ST4 7LN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Newcastle upon Tyne</city>
        <state>Tyne &amp; Wear</state>
        <zip>NE7 7DN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Coventry</city>
        <state>Warwickshire</state>
        <zip>CV2 2DX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Birmingham</city>
        <state>West Midlands</state>
        <zip>B15 2GW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Middlesbrough</city>
        <zip>TS4 3BW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Swansea</city>
        <zip>SA6 6NL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Australia</country>
    <country>Belgium</country>
    <country>Canada</country>
    <country>Czechia</country>
    <country>Denmark</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>Norway</country>
    <country>Poland</country>
    <country>Romania</country>
    <country>Russian Federation</country>
    <country>South Africa</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Czech Republic</country>
  </removed_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>September 25, 2014</study_first_submitted>
  <study_first_submitted_qc>September 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 29, 2014</study_first_posted>
  <results_first_submitted>November 7, 2019</results_first_submitted>
  <results_first_submitted_qc>November 7, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">November 27, 2019</results_first_posted>
  <last_update_submitted>November 7, 2019</last_update_submitted>
  <last_update_submitted_qc>November 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 27, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ADPKD</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthrogryposis</mesh_term>
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Polycystic Kidney Diseases</mesh_term>
    <mesh_term>Polycystic Kidney, Autosomal Dominant</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tolvaptan</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.</ipd_time_frame>
    <ipd_access_criteria>Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com</ipd_access_criteria>
  </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 6, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/75/NCT02251275/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>October 17, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/75/NCT02251275/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Eligible participants could enroll into Trial 156-13-211 after completing follow-up visit(s) of their previous trial (156-13-210, 156-08-271, 156-04-251, or 156-09-290).</recruitment_details>
      <pre_assignment_details>One participant screened, but withdrew consent on the same day (prior to study drug treatment) and is not included in the study data.&#xD;
Starting doses depended on the participant's previous trial.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Tolvaptan (From 156-13-210: Tolvaptan)</title>
          <description>Participants were previously treated with tolvaptan in Trial 156-13-210. Participants initiated on tolvaptan at a split-dose of 45/15 milligrams (mg) with upward titration every 3 to 4 days to 60/30 mg or 90/30 mg per day according to tolerability.</description>
        </group>
        <group group_id="P2">
          <title>Tolvaptan (From 156-13-210: Placebo)</title>
          <description>Participants were previously treated with placebo in Trial 156-13-210. Participants initiated on tolvaptan at a split-dose of 45/15 mg with upward titration every 3 to 4 days to 60/30 mg or 90/30 mg per day according to tolerability.</description>
        </group>
        <group group_id="P3">
          <title>Tolvaptan (From 156-08-271: Tolvaptan)</title>
          <description>Participants were previously treated with tolvaptan in Trial 156-08-271. Participants retained the last dose level of tolvaptan received in the trial (45/15 mg, 60/30 mg, or 90/30 mg) and started at that same dose in Trial 156-13-211.</description>
        </group>
        <group group_id="P4">
          <title>Tolvaptan (From Other: Tolvaptan)</title>
          <description>Participants were previously treated with tolvaptan in Other Trials (156-04-251 and 156-09-290). Participants initiated on tolvaptan at a split-dose of 45/15 mg with upward titration every 3 to 4 days to 60/30 mg or 90/30 mg per day according to tolerability.</description>
        </group>
        <group group_id="P5">
          <title>Tolvaptan (From Other: Placebo)</title>
          <description>Participants were previously treated with placebo in Other Trials (156-04-251 and 156-09-290). Participants initiated on tolvaptan at a split-dose of 45/15 mg with upward titration every 3 to 4 days to 60/30 mg or 90/30 mg per day according to tolerability.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="506"/>
                <participants group_id="P2" count="570"/>
                <participants group_id="P3" count="718"/>
                <participants group_id="P4" count="6">From trials 156-04-251 and 156-09-290</participants>
                <participants group_id="P5" count="3">From trials 156-04-251 and 156-09-290</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received at Least 1 Dose of Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="505"/>
                <participants group_id="P2" count="569"/>
                <participants group_id="P3" count="717"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="434"/>
                <participants group_id="P2" count="423"/>
                <participants group_id="P3" count="624"/>
                <participants group_id="P4" count="5"/>
                <participants group_id="P5" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="72"/>
                <participants group_id="P2" count="147"/>
                <participants group_id="P3" count="94"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="60"/>
                <participants group_id="P3" count="28"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="30"/>
                <participants group_id="P3" count="26"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Deviation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="51"/>
                <participants group_id="P3" count="35"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All participants who enrolled in the trial.</population>
      <group_list>
        <group group_id="B1">
          <title>Tolvaptan (From 156-13-210: Tolvaptan)</title>
          <description>Participants were previously treated with tolvaptan in Trial 156-13-210. Participants initiated on tolvaptan at a split-dose of 45/15 milligrams (mg) with upward titration every 3 to 4 days to 60/30 mg or 90/30 mg per day according to tolerability.</description>
        </group>
        <group group_id="B2">
          <title>Tolvaptan (From 156-13-210: Placebo)</title>
          <description>Participants were previously treated with placebo in Trial 156-13-210. Participants initiated on tolvaptan at a split-dose of 45/15 mg with upward titration every 3 to 4 days to 60/30 mg or 90/30 mg per day according to tolerability.</description>
        </group>
        <group group_id="B3">
          <title>Tolvaptan (From 156-08-271: Tolvaptan)</title>
          <description>Participants were previously treated with tolvaptan in Trial 156-08-271. Participants retained the last dose level of tolvaptan received in the trial (45/15 mg, 60/30 mg, or 90/30 mg) and started at that same dose in Trial 156-13-211.</description>
        </group>
        <group group_id="B4">
          <title>Tolvaptan (From Other: Tolvaptan)</title>
          <description>Participants were previously treated with tolvaptan in Other Trials (156-04-251 and 156-09-290). Participants initiated on tolvaptan at a split-dose of 45/15 mg with upward titration every 3 to 4 days to 60/30 mg or 90/30 mg per day according to tolerability.</description>
        </group>
        <group group_id="B5">
          <title>Tolvaptan (From Other: Placebo)</title>
          <description>Participants were previously treated with placebo in Other Trials (156-04-251 and 156-09-290). Participants initiated on tolvaptan at a split-dose of 45/15 mg with upward titration every 3 to 4 days to 60/30 mg or 90/30 mg per day according to tolerability.</description>
        </group>
        <group group_id="B6">
          <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="506"/>
            <count group_id="B2" value="570"/>
            <count group_id="B3" value="718"/>
            <count group_id="B4" value="6"/>
            <count group_id="B5" value="3"/>
            <count group_id="B6" value="1803"/>
          </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="48.9" spread="8.1"/>
                    <measurement group_id="B2" value="48.6" spread="8.0"/>
                    <measurement group_id="B3" value="45.5" spread="7.8"/>
                    <measurement group_id="B4" value="41.2" spread="11.4"/>
                    <measurement group_id="B5" value="47.0" spread="2.6"/>
                    <measurement group_id="B6" value="47.4" spread="8.1"/>
                  </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="234"/>
                    <measurement group_id="B2" value="290"/>
                    <measurement group_id="B3" value="343"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="874"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="272"/>
                    <measurement group_id="B2" value="280"/>
                    <measurement group_id="B3" value="375"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="929"/>
                  </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="27"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="49"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="102"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="479"/>
                    <measurement group_id="B2" value="545"/>
                    <measurement group_id="B3" value="669"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="1701"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="42"/>
                  </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="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="48"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="461"/>
                    <measurement group_id="B2" value="525"/>
                    <measurement group_id="B3" value="694"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="1689"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number Of Participants Reporting Treatment-Emergent Adverse Events (TEAEs)</title>
        <description>An adverse event (AE) was as any untoward medical occurrence associated with the use of an investigational medicinal product (IMP), whether or not considered IMP related. A TEAE was an AE that started after trial drug treatment; or if the event was continuous from baseline and was serious, related to IMP, or resulted in death, discontinuation, interruption or reduction of trial therapy. A serious TEAE included any event that resulted in: death, life-threatening, persistent or significant incapacity, substantial disruption of ability to conduct normal life functions, required inpatient hospitalization, prolonged hospitalization, congenital anomaly/birth defect, or other medically significant events as per medical judgment, that jeopardized the participant and that required medical or surgical intervention. A severe TEAE was an inability to work or perform normal daily activity. A summary of serious and all other non-serious TEAEs, regardless of causality, is located in the AE section.</description>
        <time_frame>Baseline through end of treatment (up to 42 months) and follow-up 7 days posttreatment(+ 7 days)</time_frame>
        <population>All participants who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Tolvaptan (From 156-13-210: Tolvaptan)</title>
            <description>Participants were previously treated with tolvaptan in Trial 156-13-210. Participants initiated on tolvaptan at a split-dose of 45/15 milligrams (mg) with upward titration every 3 to 4 days to 60/30 mg or 90/30 mg per day according to tolerability.</description>
          </group>
          <group group_id="O2">
            <title>Tolvaptan (From 156-13-210: Placebo)</title>
            <description>Participants were previously treated with placebo in Trial 156-13-210. Participants initiated on tolvaptan at a split-dose of 45/15 mg with upward titration every 3 to 4 days to 60/30 mg or 90/30 mg per day according to tolerability.</description>
          </group>
          <group group_id="O3">
            <title>Tolvaptan (From 156-08-271: Tolvaptan)</title>
            <description>Participants were previously treated with tolvaptan in Trial 156-08-271. Participants retained the last dose level of tolvaptan received in the trial (45/15 mg, 60/30 mg, or 90/30 mg) and started at that same dose in Trial 156-13-211.</description>
          </group>
          <group group_id="O4">
            <title>Tolvaptan (From Other: Tolvaptan)</title>
            <description>Participants were previously treated with tolvaptan in Other Trials (156-04-251 and 156-09-290). Participants initiated on tolvaptan at a split-dose of 45/15 mg with upward titration every 3 to 4 days to 60/30 mg or 90/30 mg per day according to tolerability.</description>
          </group>
          <group group_id="O5">
            <title>Tolvaptan (From Other: Placebo)</title>
            <description>Participants were previously treated with placebo in Other Trials (156-04-251 and 156-09-290). Participants initiated on tolvaptan at a split-dose of 45/15 mg with upward titration every 3 to 4 days to 60/30 mg or 90/30 mg per day according to tolerability.</description>
          </group>
        </group_list>
        <measure>
          <title>Number Of Participants Reporting Treatment-Emergent Adverse Events (TEAEs)</title>
          <description>An adverse event (AE) was as any untoward medical occurrence associated with the use of an investigational medicinal product (IMP), whether or not considered IMP related. A TEAE was an AE that started after trial drug treatment; or if the event was continuous from baseline and was serious, related to IMP, or resulted in death, discontinuation, interruption or reduction of trial therapy. A serious TEAE included any event that resulted in: death, life-threatening, persistent or significant incapacity, substantial disruption of ability to conduct normal life functions, required inpatient hospitalization, prolonged hospitalization, congenital anomaly/birth defect, or other medically significant events as per medical judgment, that jeopardized the participant and that required medical or surgical intervention. A severe TEAE was an inability to work or perform normal daily activity. A summary of serious and all other non-serious TEAEs, regardless of causality, is located in the AE section.</description>
          <population>All participants who received at least 1 dose of study drug.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="505"/>
                <count group_id="O2" value="569"/>
                <count group_id="O3" value="717"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Participants with TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="473"/>
                    <measurement group_id="O2" value="531"/>
                    <measurement group_id="O3" value="640"/>
                    <measurement group_id="O4" value="6"/>
                    <measurement group_id="O5" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with serious TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87"/>
                    <measurement group_id="O2" value="96"/>
                    <measurement group_id="O3" value="103"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with severe TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74"/>
                    <measurement group_id="O2" value="78"/>
                    <measurement group_id="O3" value="83"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Discontinued due to TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                    <measurement group_id="O2" value="65"/>
                    <measurement group_id="O3" value="38"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Deaths</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline through end of treatment (up to 42 months) and follow-up 7 days posttreatment (+ 7 days)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Tolvaptan (From 156-13-210: Tolvaptan)</title>
          <description>Participants were previously treated with tolvaptan in Trial 156-13-210. Participants initiated on tolvaptan at a split-dose of 45/15 milligrams (mg) with upward titration every 3 to 4 days to 60/30 mg or 90/30 mg per day according to tolerability.</description>
        </group>
        <group group_id="E2">
          <title>Tolvaptan (From 156-13-210: Placebo)</title>
          <description>Participants were previously treated with placebo in Trial 156-13-210. Participants initiated on tolvaptan at a split-dose of 45/15 mg with upward titration every 3 to 4 days to 60/30 mg or 90/30 mg per day according to tolerability.</description>
        </group>
        <group group_id="E3">
          <title>Tolvaptan (From 156-08-271: Tolvaptan)</title>
          <description>Participants were previously treated with tolvaptan in Trial 156-08-271. Participants retained the last dose level of tolvaptan received in the trial (45/15 mg, 60/30 mg, or 90/30 mg) and started at that same dose in Trial 156-13-211.</description>
        </group>
        <group group_id="E4">
          <title>Tolvaptan (From Other: Tolvaptan)</title>
          <description>Participants were previously treated with tolvaptan in Other Trials (156-04-251 and 156-09-290). Participants initiated on tolvaptan at a split-dose of 45/15 mg with upward titration every 3 to 4 days to 60/30 mg or 90/30 mg per day according to tolerability.</description>
        </group>
        <group group_id="E5">
          <title>Tolvaptan (From Other: Placebo)</title>
          <description>Participants were previously treated with placebo in Other Trials (156-04-251 and 156-09-290). Participants initiated on tolvaptan at a split-dose of 45/15 mg with upward titration every 3 to 4 days to 60/30 mg or 90/30 mg per day according to tolerability.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDra 21.0</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="1" subjects_at_risk="505"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="569"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="717"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="87" subjects_at_risk="505"/>
                <counts group_id="E2" subjects_affected="96" subjects_at_risk="569"/>
                <counts group_id="E3" subjects_affected="103" subjects_at_risk="717"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Haemorrhagic Anaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Leukocytosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Pancytopenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Ventricular Tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Pericarditis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Pericardial Effusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Myocardial Infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Mitral Valve Prolapse</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Left Ventricular Dysfunction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Coronary Artery Stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Coronary Artery Disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Cardiogenic Shock</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Cardiac Failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Cardiac Arrest</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Atrial Fibrillation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Aortic Valve Incompetence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Angina Unstable</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Angina Pectoris</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Acute Myocardial Infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Acute Left Ventricular Failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Acute Coronary Syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Polycystic Liver Disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Urachal Abnormality</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Deafness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Retinal Detachment</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Borderline Glaucoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Diplopia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Endocrine Ophthalmopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastrointestinal Disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Upper Gastrointestinal Haemorrhage</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Umbilical Hernia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Small Intestinal Obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Pancreatitis Acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Lower Gastrointestinal Haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Intestinal Obstruction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Inguinal Hernia, Obstructive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Inguinal Hernia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Incarcerated Umbilical Hernia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Colitis Ischaemic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal Reflux Disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Gastric Ulcer Haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Duodenal Perforation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Diverticulum</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Haematemesis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Abdominal Pain Upper</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Abdominal Pain Lower</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Abdominal Hernia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Thirst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Oedema Peripheral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Chest Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Non-Cardiac Chest Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Chest Discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Bile Duct Stone</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Hepatic Cyst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Hepatic Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Ischaemic Hepatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Drug Hypersensitivity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pulmonary Tuberculosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Postoperative Wound Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Renal Abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Renal Cyst Infection</sub_title>
                <counts group_id="E1" events="7" subjects_affected="5" subjects_at_risk="505"/>
                <counts group_id="E2" events="10" subjects_affected="8" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Salmonellosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="569"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="505"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="569"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Staphylococcal Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Superinfection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Tonsillitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Viral Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Pneumonia Staphylococcal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Septic Shock</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="505"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Abdominal Wall Abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Ophthalmic Herpes Zoster</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Appendicitis Perforated</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Cat Scratch Disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Clostridium Difficile Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Peritonitis Bacterial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Diarrhoea Infectious</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Cytomegalovirus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Escherichia Bacteraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Escherichia Urinary Tract Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="505"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Hepatic Cyst Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Herpes Zoster</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Herpes Zoster Oticus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Infected Cyst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Endocarditis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Radius Fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Tibia Fracture</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Tendon Rupture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Subdural Haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Subarachnoid Haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Spinal Fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Perirenal Haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Traumatic Haemothorax</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Incisional Hernia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Humerus Fracture</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Fibula Fracture</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Brain Contusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Arteriovenous Fistula Site Haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Ankle Fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Anastomotic Complication</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Meniscus Injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Accidental Overdose</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Weight Decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Tumour Marker Increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Liver Function Test Increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>International Normalised Ratio Fluctuation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Hepatic Enzyme Increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="505"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Glomerular Filtration Rate Decreased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="505"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Transaminases Increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>C-Reactive Protein Increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Gamma-Glutamyltransferase Increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="505"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Alanine Aminotransferase Increased</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="505"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Aspartate Aminotransferase Increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Alanine Aminotransferase Abnormal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Blood Creatinine Increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="569"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Blood Glucose Increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Blood Alkaline Phosphatase Increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Blood Urine Present</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Diabetes Mellitus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Hypernatraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Hypophosphataemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Metabolic Acidosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Obesity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Spinal Osteoarthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Foot Deformity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Pain In Extremity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Metastatic Squamous Cell Carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Squamous Cell Carcinoma of Head and Neck</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Squamous Cell Carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Renal Neoplasm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Rectal Cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Prostate Cancer</sub_title>
                <description>The adverse event occurs in only male participants.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="272"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="280"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="375"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Papillary Thyroid Cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Ovarian Theca Cell Tumour</sub_title>
                <description>The adverse event occurs in only female participants.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="234"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="290"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="343"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Metastases to Meninges</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Carcinoid Tumour</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Metastases to Adrenals</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Metastases to Liver</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Basal Cell Carcinoma</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Bone Cancer Metastatic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>B-Cell Small Lymphocytic Lymphoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Colon Cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Intraductal Proliferative Breast Lesion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Malignant Melanoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Bronchial Carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Breast Cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Transient Ischaemic Attack</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Sciatica</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Ruptured Cerebral Aneurysm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Vith Nerve Paralysis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Intracranial Aneurysm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Basilar Artery Aneurysm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Cerebellar Ischaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Ischaemic Stroke</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Cerebrovascular Accident</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Encephalopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Cerebral Ischaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Epilepsy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Panic Attack</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Suicidal Ideation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal Pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="505"/>
                <counts group_id="E2" events="7" subjects_affected="5" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Renal Impairment</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="505"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="569"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Renal Haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Renal Failure</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Renal Cyst Haemorrhage</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="505"/>
                <counts group_id="E2" events="6" subjects_affected="4" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Renal Cyst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Renal Colic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Renal Cyst Ruptured</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Pollakiuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Nephropathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Acute Kidney Injury</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="505"/>
                <counts group_id="E2" events="9" subjects_affected="8" subjects_at_risk="569"/>
                <counts group_id="E3" events="7" subjects_affected="7" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Kidney Enlargement</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>End Stage Renal Disease</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="8" subjects_affected="8" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Chronic Kidney Disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Polyuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Rectocele</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Prostatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Menorrhagia</sub_title>
                <description>The adverse event occurs in only female participants.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="234"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="290"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="343"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Breast Enlargement</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Metrorrhagia</sub_title>
                <description>The adverse event occurs in only female participants.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="234"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="290"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="343"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Sinus Polyp</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Respiratory Failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Pleuritic Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Pulmonary Toxicity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Pulmonary Embolism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Pleural Effusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Haemothorax</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Acute Respiratory Distress Syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Acute Respiratory Failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Acute Pulmonary Oedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Chronic Obstructive Pulmonary Disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Bronchospasm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </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="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Rash Vesicular</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Skin Laxity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Skin Lesion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Thrombophlebitis Superficial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Shock</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Peripheral Ischaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Hypertensive Crisis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Deep Vein Thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Arteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Aortic Dissection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Aneurysm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Aortic Aneurysm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDra 21.0</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="469" subjects_at_risk="505"/>
                <counts group_id="E2" subjects_affected="525" subjects_at_risk="569"/>
                <counts group_id="E3" subjects_affected="633" subjects_at_risk="717"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Left Ventricular Hypertrophy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="505"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="569"/>
                <counts group_id="E3" events="15" subjects_affected="14" subjects_at_risk="717"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoacusis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Motion Sickness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Discomfort</sub_title>
                <counts group_id="E1" events="10" subjects_affected="9" subjects_at_risk="505"/>
                <counts group_id="E2" events="16" subjects_affected="14" subjects_at_risk="569"/>
                <counts group_id="E3" events="5" subjects_affected="4" subjects_at_risk="717"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Abdominal Hernia</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Abdominal Pain Lower</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="505"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="569"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="717"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Abdominal Pain Upper</sub_title>
                <counts group_id="E1" events="24" subjects_affected="20" subjects_at_risk="505"/>
                <counts group_id="E2" events="24" subjects_affected="19" subjects_at_risk="569"/>
                <counts group_id="E3" events="12" subjects_affected="12" subjects_at_risk="717"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="17" subjects_affected="16" subjects_at_risk="505"/>
                <counts group_id="E2" events="34" subjects_affected="28" subjects_at_risk="569"/>
                <counts group_id="E3" events="11" subjects_affected="10" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="41" subjects_affected="37" subjects_at_risk="505"/>
                <counts group_id="E2" events="43" subjects_affected="38" subjects_at_risk="569"/>
                <counts group_id="E3" events="39" subjects_affected="33" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Dry Mouth</sub_title>
                <counts group_id="E1" events="24" subjects_affected="22" subjects_at_risk="505"/>
                <counts group_id="E2" events="41" subjects_affected="38" subjects_at_risk="569"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="19" subjects_affected="17" subjects_at_risk="505"/>
                <counts group_id="E2" events="28" subjects_affected="27" subjects_at_risk="569"/>
                <counts group_id="E3" events="10" subjects_affected="10" subjects_at_risk="717"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal Reflux Disease</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="505"/>
                <counts group_id="E2" events="22" subjects_affected="19" subjects_at_risk="569"/>
                <counts group_id="E3" events="17" subjects_affected="17" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Gingival Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="40" subjects_affected="37" subjects_at_risk="505"/>
                <counts group_id="E2" events="59" subjects_affected="51" subjects_at_risk="569"/>
                <counts group_id="E3" events="40" subjects_affected="38" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="27" subjects_affected="24" subjects_at_risk="505"/>
                <counts group_id="E2" events="41" subjects_affected="38" subjects_at_risk="569"/>
                <counts group_id="E3" events="36" subjects_affected="32" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest Discomfort</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="55" subjects_affected="47" subjects_at_risk="505"/>
                <counts group_id="E2" events="85" subjects_affected="74" subjects_at_risk="569"/>
                <counts group_id="E3" events="37" subjects_affected="34" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Non-Cardiac Chest Pain</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="505"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="569"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="717"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Oedema Peripheral</sub_title>
                <counts group_id="E1" events="37" subjects_affected="32" subjects_at_risk="505"/>
                <counts group_id="E2" events="46" subjects_affected="39" subjects_at_risk="569"/>
                <counts group_id="E3" events="49" subjects_affected="42" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="9" subjects_affected="6" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="717"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Thirst</sub_title>
                <counts group_id="E1" events="176" subjects_affected="139" subjects_at_risk="505"/>
                <counts group_id="E2" events="213" subjects_affected="183" subjects_at_risk="569"/>
                <counts group_id="E3" events="99" subjects_affected="91" subjects_at_risk="717"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Type I Hypersensitivity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="25" subjects_affected="23" subjects_at_risk="505"/>
                <counts group_id="E2" events="34" subjects_affected="29" subjects_at_risk="569"/>
                <counts group_id="E3" events="35" subjects_affected="31" subjects_at_risk="717"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Ear Infection</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="505"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="569"/>
                <counts group_id="E3" events="8" subjects_affected="5" subjects_at_risk="717"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="15" subjects_affected="14" subjects_at_risk="505"/>
                <counts group_id="E2" events="24" subjects_affected="22" subjects_at_risk="569"/>
                <counts group_id="E3" events="44" subjects_affected="41" subjects_at_risk="717"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Gingivitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="505"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="569"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="717"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="38" subjects_affected="34" subjects_at_risk="505"/>
                <counts group_id="E2" events="49" subjects_affected="43" subjects_at_risk="569"/>
                <counts group_id="E3" events="52" subjects_affected="39" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="129" subjects_affected="92" subjects_at_risk="505"/>
                <counts group_id="E2" events="143" subjects_affected="100" subjects_at_risk="569"/>
                <counts group_id="E3" events="123" subjects_affected="94" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="30" subjects_affected="22" subjects_at_risk="505"/>
                <counts group_id="E2" events="37" subjects_affected="31" subjects_at_risk="569"/>
                <counts group_id="E3" events="47" subjects_affected="35" subjects_at_risk="717"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" events="64" subjects_affected="58" subjects_at_risk="505"/>
                <counts group_id="E2" events="83" subjects_affected="53" subjects_at_risk="569"/>
                <counts group_id="E3" events="129" subjects_affected="86" subjects_at_risk="717"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" events="86" subjects_affected="52" subjects_at_risk="505"/>
                <counts group_id="E2" events="79" subjects_affected="58" subjects_at_risk="569"/>
                <counts group_id="E3" events="117" subjects_affected="65" subjects_at_risk="717"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Vulvovaginal Mycotic Infection</sub_title>
                <description>The adverse event occurs in only female participants.</description>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="234"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="290"/>
                <counts group_id="E3" events="7" subjects_affected="6" subjects_at_risk="343"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Zika Virus Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="10" subjects_affected="8" subjects_at_risk="505"/>
                <counts group_id="E2" events="10" subjects_affected="9" subjects_at_risk="569"/>
                <counts group_id="E3" events="11" subjects_affected="11" subjects_at_risk="717"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine Aminotransferase Increased</sub_title>
                <counts group_id="E1" events="9" subjects_affected="7" subjects_at_risk="505"/>
                <counts group_id="E2" events="26" subjects_affected="19" subjects_at_risk="569"/>
                <counts group_id="E3" events="21" subjects_affected="17" subjects_at_risk="717"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Blood Calcium Increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Blood Creatinine Increased</sub_title>
                <counts group_id="E1" events="104" subjects_affected="77" subjects_at_risk="505"/>
                <counts group_id="E2" events="129" subjects_affected="87" subjects_at_risk="569"/>
                <counts group_id="E3" events="87" subjects_affected="69" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Kidney Palpable</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Weight Decreased</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="505"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="569"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Weight Increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="569"/>
                <counts group_id="E3" events="5" subjects_affected="4" subjects_at_risk="717"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased Appetite</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="505"/>
                <counts group_id="E2" events="19" subjects_affected="18" subjects_at_risk="569"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Gout</sub_title>
                <counts group_id="E1" events="49" subjects_affected="28" subjects_at_risk="505"/>
                <counts group_id="E2" events="46" subjects_affected="25" subjects_at_risk="569"/>
                <counts group_id="E3" events="42" subjects_affected="30" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Hyperlipidaemia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="505"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="569"/>
                <counts group_id="E3" events="7" subjects_affected="7" subjects_at_risk="717"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Polydipsia</sub_title>
                <counts group_id="E1" events="29" subjects_affected="27" subjects_at_risk="505"/>
                <counts group_id="E2" events="54" subjects_affected="53" subjects_at_risk="569"/>
                <counts group_id="E3" events="14" subjects_affected="14" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="42" subjects_affected="33" subjects_at_risk="505"/>
                <counts group_id="E2" events="26" subjects_affected="25" subjects_at_risk="569"/>
                <counts group_id="E3" events="36" subjects_affected="26" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Back Pain</sub_title>
                <counts group_id="E1" events="59" subjects_affected="53" subjects_at_risk="505"/>
                <counts group_id="E2" events="71" subjects_affected="57" subjects_at_risk="569"/>
                <counts group_id="E3" events="55" subjects_affected="51" subjects_at_risk="717"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="20" subjects_affected="18" subjects_at_risk="505"/>
                <counts group_id="E2" events="37" subjects_affected="31" subjects_at_risk="569"/>
                <counts group_id="E3" events="37" subjects_affected="31" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="61" subjects_affected="51" subjects_at_risk="505"/>
                <counts group_id="E2" events="83" subjects_affected="72" subjects_at_risk="569"/>
                <counts group_id="E3" events="68" subjects_affected="51" subjects_at_risk="717"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="569"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="717"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="505"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="569"/>
                <counts group_id="E3" events="15" subjects_affected="13" subjects_at_risk="717"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Stress</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="505"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Chronic Kidney Disease</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="505"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="569"/>
                <counts group_id="E3" events="7" subjects_affected="7" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" events="34" subjects_affected="27" subjects_at_risk="505"/>
                <counts group_id="E2" events="63" subjects_affected="52" subjects_at_risk="569"/>
                <counts group_id="E3" events="53" subjects_affected="48" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Nocturia</sub_title>
                <counts group_id="E1" events="105" subjects_affected="77" subjects_at_risk="505"/>
                <counts group_id="E2" events="150" subjects_affected="124" subjects_at_risk="569"/>
                <counts group_id="E3" events="63" subjects_affected="58" subjects_at_risk="717"/>
                <counts group_id="E4" events="4" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E5" events="2" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Pollakiuria</sub_title>
                <counts group_id="E1" events="36" subjects_affected="27" subjects_at_risk="505"/>
                <counts group_id="E2" events="38" subjects_affected="34" subjects_at_risk="569"/>
                <counts group_id="E3" events="18" subjects_affected="12" subjects_at_risk="717"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Polyuria</sub_title>
                <counts group_id="E1" events="141" subjects_affected="117" subjects_at_risk="505"/>
                <counts group_id="E2" events="203" subjects_affected="180" subjects_at_risk="569"/>
                <counts group_id="E3" events="56" subjects_affected="53" subjects_at_risk="717"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Renal Cyst Ruptured</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="505"/>
                <counts group_id="E2" events="12" subjects_affected="9" subjects_at_risk="569"/>
                <counts group_id="E3" events="8" subjects_affected="7" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Renal Impairment</sub_title>
                <counts group_id="E1" events="12" subjects_affected="12" subjects_at_risk="505"/>
                <counts group_id="E2" events="31" subjects_affected="29" subjects_at_risk="569"/>
                <counts group_id="E3" events="16" subjects_affected="14" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Renal Pain</sub_title>
                <counts group_id="E1" events="139" subjects_affected="98" subjects_at_risk="505"/>
                <counts group_id="E2" events="179" subjects_affected="110" subjects_at_risk="569"/>
                <counts group_id="E3" events="209" subjects_affected="141" subjects_at_risk="717"/>
                <counts group_id="E4" events="4" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E5" events="3" subjects_affected="2" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Vaginal Haemorrhage</sub_title>
                <description>The adverse event occurs in only female participants.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="234"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="290"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="343"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="30" subjects_affected="27" subjects_at_risk="505"/>
                <counts group_id="E2" events="31" subjects_affected="27" subjects_at_risk="569"/>
                <counts group_id="E3" events="31" subjects_affected="28" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Wheezing</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="717"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis Contact</sub_title>
                <counts group_id="E1" events="9" subjects_affected="7" subjects_at_risk="505"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="569"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="116" subjects_affected="87" subjects_at_risk="505"/>
                <counts group_id="E2" events="97" subjects_affected="77" subjects_at_risk="569"/>
                <counts group_id="E3" events="163" subjects_affected="139" subjects_at_risk="717"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Lymphoedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="505"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="569"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="717"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Orthostatic Hypotension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="505"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="569"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="717"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </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>Sponsor reserves the right to review results publications prior to public release and can delay such publications for a period greater than 60 days but no more than 120 days from the date that the publication is submitted to the Sponsor for review. Sponsor can require changes to the publication to protect Sponsor's intellectual property rights and/or confidential information and reserves the right to limit publication timing and scope of data published based on the number of study locations.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Global Clinical Development</name_or_title>
      <organization>Otsuka Pharmaceutical Development &amp; Commercialization, Inc.</organization>
      <phone>+1-609-524-6788</phone>
      <email>clinicaltransparency@otsuka-us.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/NCT02251275
org study id: 156-13-211
nct id: NCT02251275
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of the trial was to evaluate and describe the long term safety of tolvaptan in
      participants with autosomal dominant polycystic kidney disease (ADPKD).
This was a Phase 3b trial to evaluate and describe the long term safety of tolvaptan
      treatment in ADPKD participants with chronic kidney disease (CKD). Eligible participants
      could enroll into Trial 156-13-211 after completing the follow-up visit(s) of their previous
      trial (156-13-210, 156-08-271, 156-04-251, or 156-09-290). Renal function was assessed during
      screening by using historical laboratory values for serum creatinine levels to calculate the
      estimated glomerular filtration rate (eGFR).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number Of Participants Reporting Treatment-Emergent Adverse Events (TEAEs)
time frame: Baseline through end of treatment (up to 42 months) and follow-up 7 days posttreatment(+ 7 days)
description: An adverse event (AE) was as any untoward medical occurrence associated with the use of an investigational medicinal product (IMP), whether or not considered IMP related. A TEAE was an AE that started after trial drug treatment; or if the event was continuous from baseline and was serious, related to IMP, or resulted in death, discontinuation, interruption or reduction of trial therapy. A serious TEAE included any event that resulted in: death, life-threatening, persistent or significant incapacity, substantial disruption of ability to conduct normal life functions, required inpatient hospitalization, prolonged hospitalization, congenital anomaly/birth defect, or other medically significant events as per medical judgment, that jeopardized the participant and that required medical or surgical intervention. A severe TEAE was an inability to work or perform normal daily activity. A summary of serious and all other non-serious TEAEs, regardless of causality, is located in the AE section.
arm group label: Tolvaptan
arm group type: Experimental
description: Tolvaptan was self-administered orally as split-dose regimens. The dose regimens used in this trial were 15/15 milligram (mg), 30/15 mg, 45/15 mg, 60/30 mg, or 90/30 mg. Starting doses were dependent upon the participant's previous trial as follows:
Trial 156-13-210: initiated on tolvaptan at a split-dose of 45/15 mg with upward titration every 3 to 4 days to 60/30 mg or 90/30 mg per day according to tolerability.
Trial 156-08-271: retained the last dose level of tolvaptan received in the trial (45/15 mg, 60/30 mg, or 90/30 mg) and started at that same dose in Trial 156-13-211.
Other Trials (156-04-251 and 156-09-290): initiated on tolvaptan at a split-dose of 45/15 mg with upward titration every 3 to 4 days to 60/30 mg or 90/30 mg per day according to tolerability.
intervention type: Drug
intervention name: Tolvaptan
description: Tolvaptan tablets (15 or 30 mg) self-administered orally as split-dose regimens, once upon awakening and another approximately 8 to 9 hours later
arm group label: Tolvaptan
other name: OPC-41061
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
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country: Argentina
country: Australia
country: Belgium
country: Canada
country: Czechia
country: Denmark
country: Germany
country: Hungary
country: Israel
country: Italy
country: Netherlands
country: Norway
country: Poland
country: Romania
country: Russian Federation
country: South Africa
country: Spain
country: Sweden
country: United Kingdom
country: United States
country: Czech Republic
responsible party type: Sponsor
mesh term: Arthrogryposis
mesh term: Kidney Diseases
mesh term: Polycystic Kidney Diseases
mesh term: Polycystic Kidney, Autosomal Dominant
mesh term: Tolvaptan
sharing ipd: Yes
ipd description: Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
ipd access criteria: Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com
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reported events: 
certain agreements: 
point of contact: 