<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/NCT02200614</url>
  </required_header>
  <id_info>
    <org_study_id>17712</org_study_id>
    <secondary_id>2013-003820-36</secondary_id>
    <nct_id>NCT02200614</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety Study of Darolutamide (ODM-201) in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer</brief_title>
  <acronym>ARAMIS</acronym>
  <official_title>A Multinational, Randomised, Double-blind, Placebo-controlled, Phase III Efficacy and Safety Study of Darolutamide (ODM-201) in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bayer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Orion Corporation, Orion Pharma</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Bayer</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the safety and efficacy of BAY1841788 (ODM-201) in&#xD;
      patients with non-metastatic castration-resistant prostate cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 12, 2014</start_date>
  <completion_date type="Actual">June 14, 2021</completion_date>
  <primary_completion_date type="Actual">September 3, 2018</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Metastasis-Free Survival</measure>
    <time_frame>From randomization to the time approximately 385 MFS events were observed (approximately 48 months)</time_frame>
    <description>Metastasis-Free Survival (MFS) is defined as the time from randomisation to evidence of metastasis or death from any cause, whichever occurs first (cut-off date 15 Nov 2019)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival - Primary Analysis</measure>
    <time_frame>From randomization of the first subject to the time approximatively 140 death events were observed (approximately 48 months)</time_frame>
    <description>Overall Survival (OS) was defined as the time from randomization to death due to any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Pain Progression - Primary Analysis</measure>
    <time_frame>From randomization until last study treatment (assessed every 4 months) (approximately 48 months)</time_frame>
    <description>Time to pain progression (PP) is defined as time from randomization to pain progression, where progression is defined as an increase of 2 or more points from baseline in question 3 of the Brief Pain Inventory-Short Form questionnaire (BPI-SF) related to the worst pain in the last 24 hours taken as a 7-day average for post-baseline scores, or initiation of short or long-acting opioids for pain, whichever comes first. Initiation or change in the use of other non-opioid analgesics is not used in the analysis of pain progression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Initiation of First Cytotoxic Chemotherapy for Prostate Cancer - Primary Analysis</measure>
    <time_frame>From randomization until last study treatment (assessed every 4 months) (approximately 48 months)</time_frame>
    <description>The time to cytotoxic chemotherapy was defined as the time from randomization to the start of the first cytotoxic chemotherapy cycle.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to First Symptomatic Skeletal Event (SSE) - Primary Analysis</measure>
    <time_frame>From randomization until last study treatment (assessed every 4 months) (approximately 48 months)</time_frame>
    <description>The time to the first SSE was defined as the time from randomization to the occurrence of the first SSE.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival - Final Analysis</measure>
    <time_frame>From randomization of the first subject to the time approximatively 254 death events were observed (approximately 56 months)</time_frame>
    <description>Overall Survival (OS) was defined as the time from randomization to death due to any cause. The final analysis was done at the time of the data cut-off (15 NOV 2019).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Pain Progression - Final Analysis</measure>
    <time_frame>From randomization until last study treatment (assessed every 4 months) (approximately 48 months)</time_frame>
    <description>For time to pain progression, the analysis performed using the primary completion cut-off data (03 SEP 2018) was considered final and no new analysis was performed for time to pain progression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Initiation of First Cytotoxic Chemotherapy for Prostate Cancer - Final Analysis</measure>
    <time_frame>From randomization until initiation of first cytotoxic chemotherapy treatment (approximately 59 months)</time_frame>
    <description>The time to cytotoxic chemotherapy was defined as the time from randomization to the start of the first cytotoxic chemotherapy cycle. The final analysis was done at the time of the data cut-off (15 NOV 2019).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to First Symptomatic Skeletal Event (SSE) - Final Analysis</measure>
    <time_frame>From randomization until occurrence of first SSE event (approximately 59 months)</time_frame>
    <description>The time to the first SSE was defined as the time from randomization to the occurrence of the first SSE. The final analysis was done at the time of the data cut-off (15 NOV 2019).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1509</enrollment>
  <condition>Prostate Cancer Non-Metastatic</condition>
  <condition>Castration-Resistant</condition>
  <arm_group>
    <arm_group_label>Darolutamide (BAY1841788)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received Darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants received matching placebo 2 tablets twice daily with food.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Darolutamide (Nubeqa, BAY1841788)</intervention_name>
    <description>Darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg.</description>
    <arm_group_label>Darolutamide (BAY1841788)</arm_group_label>
    <other_name>ODM-201</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Matching placebo 2 tablets twice daily with food.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically or cytologically confirmed adenocarcinoma of prostate without&#xD;
             neuroendocrine differentiation or small cell features.&#xD;
&#xD;
          -  Castration-resistant prostate cancer (CRPC) with castrate level of serum testosterone.&#xD;
&#xD;
          -  Prostate-specific Antigen (PSA) doubling time of ≤ 10 months and PSA &gt; 2ng/ml.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.&#xD;
&#xD;
          -  Blood counts at screening: haemoglobin ≥ 9.0 g/dl,absolute neutrophil count ≥ 1500/µl,&#xD;
             platelet count ≥ 100,000/µl.&#xD;
&#xD;
          -  Screening values of serum alanine aminotransferase (ALT) and/or aspartate transaminase&#xD;
             (AST) ≤ 2.5 x upper limit of normal (ULN), total bilirubin ≤ 1.5 x ULN, creatinine ≤&#xD;
             2.0 x ULN.&#xD;
&#xD;
          -  Sexually active patients, unless surgically sterile, must agree to use condoms as an&#xD;
             effective barrier method and refrain from sperm donation during the study treatment&#xD;
             and for 3 months after the end of the study treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of metastatic disease at any time or presence of detectable metastases.&#xD;
&#xD;
          -  Acute toxicities of prior treatments and procedures not resolved to grade ≤ 1 or&#xD;
             baseline before randomisation.&#xD;
&#xD;
          -  Prior treatment with: second generation androgen receptor (AR) inhibitors, other&#xD;
             investigational AR inhibitors, or CYP17 enzyme inhibitor.&#xD;
&#xD;
          -  Use of estrogens or 5-α reductase inhibitors or AR inhibitors.&#xD;
&#xD;
          -  Prior chemotherapy or immunotherapy for prostate cancer.&#xD;
&#xD;
          -  Use of systemic corticosteroid.&#xD;
&#xD;
          -  Radiation therapy within 12 weeks before randomisation.&#xD;
&#xD;
          -  Severe or uncontrolled concurrent disease, infection or co-morbidity.&#xD;
&#xD;
          -  Treatment with bisphosphonate or denosumab within 12 weeks before randomisation.&#xD;
&#xD;
          -  Known hypersensitivity to the study treatment or any of its ingredients.&#xD;
&#xD;
          -  Major surgery within 28 days before randomisation.&#xD;
&#xD;
          -  Any of the following within 6 months before randomisation: stroke, myocardial&#xD;
             infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft;&#xD;
             congestive heart failure New York Heart Association (NYHA) Class III or IV.&#xD;
&#xD;
          -  Uncontrolled hypertension.&#xD;
&#xD;
          -  Prior malignancy.&#xD;
&#xD;
          -  Gastrointestinal disorder or procedure which expects to interfere significantly with&#xD;
             absorption of study treatment.&#xD;
&#xD;
          -  Active viral hepatitis, active human immunodeficiency virus (HIV) or chronic liver&#xD;
             disease.&#xD;
&#xD;
          -  Treatment with any investigational drug within 28 days before randomisation.&#xD;
&#xD;
          -  Any condition that in the opinion of the investigator would impair the patients'&#xD;
             ability to comply with the study procedures.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bayer Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Bayer</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Homewood</city>
        <state>Alabama</state>
        <zip>35209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Anchorage</city>
        <state>Alaska</state>
        <zip>99503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Fountain Valley</city>
        <state>California</state>
        <zip>92708</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Laguna Hills</city>
        <state>California</state>
        <zip>92653</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90073-1003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Whittier</city>
        <state>California</state>
        <zip>90603</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80220</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Parker</city>
        <state>Colorado</state>
        <zip>80134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33486</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Port Saint Lucie</city>
        <state>Florida</state>
        <zip>34952</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Coeur d'Alene</city>
        <state>Idaho</state>
        <zip>83814</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Evanston</city>
        <state>Illinois</state>
        <zip>60201-1613</zip>
        <country>United States</country>
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  </location>
  <location>
    <facility>
      <address>
        <city>Springfield</city>
        <state>Illinois</state>
        <zip>62702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Greenwood</city>
        <state>Indiana</state>
        <zip>46143</zip>
        <country>United States</country>
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  </location>
  <location>
    <facility>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
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  </location>
  <location>
    <facility>
      <address>
        <city>Jeffersonville</city>
        <state>Indiana</state>
        <zip>47130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>West Des Moines</city>
        <state>Iowa</state>
        <zip>50266</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Annapolis</city>
        <state>Maryland</state>
        <zip>21401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Salisbury</city>
        <state>Maryland</state>
        <zip>21801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Grand Rapids</city>
        <state>Michigan</state>
        <zip>49546</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Royal Oak</city>
        <state>Michigan</state>
        <zip>48073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03756-1000</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Voorhees</city>
        <state>New Jersey</state>
        <zip>08043</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10461</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10469</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Syracuse</city>
        <state>New York</state>
        <zip>13210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Asheboro</city>
        <state>North Carolina</state>
        <zip>27203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28277</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Canton</city>
        <state>Ohio</state>
        <zip>44718</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
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  <location>
    <facility>
      <address>
        <city>Gahanna</city>
        <state>Ohio</state>
        <zip>43230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Middleburg Heights</city>
        <state>Ohio</state>
        <zip>44130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bala-Cynwyd</city>
        <state>Pennsylvania</state>
        <zip>19004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Myrtle Beach</city>
        <state>South Carolina</state>
        <zip>29572</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Fairfax</city>
        <state>Virginia</state>
        <zip>22031</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Virginia Beach</city>
        <state>Virginia</state>
        <zip>23462</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Wheeling</city>
        <state>West Virginia</state>
        <zip>26003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Buenos Aires</city>
        <state>Ciudad Auton. De Buenos Aires</state>
        <zip>C1120AAT</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Santa Fé</city>
        <state>Santa Fe</state>
        <zip>S3000FFV</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
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      <address>
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  <location>
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  <location>
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        <city>Zirndorf</city>
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        <zip>90513</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Frankfurt</city>
        <state>Hessen</state>
        <zip>60590</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Marburg</city>
        <state>Hessen</state>
        <zip>35039</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hagenow</city>
        <state>Mecklenburg-Vorpommern</state>
        <zip>19230</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Herzberg Am Harz</city>
        <state>Niedersachsen</state>
        <zip>37412</zip>
        <country>Germany</country>
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    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Holzminden</city>
        <state>Niedersachsen</state>
        <zip>37603</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Düsseldorf</city>
        <state>Nordrhein-Westfalen</state>
        <zip>40225</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Köln</city>
        <state>Nordrhein-Westfalen</state>
        <zip>50937</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Mühlheim</city>
        <state>Nordrhein-Westfalen</state>
        <zip>45468</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Münster</city>
        <state>Nordrhein-Westfalen</state>
        <zip>48149</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Wuppertal</city>
        <state>Nordrhein-Westfalen</state>
        <zip>42103</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Mainz</city>
        <state>Rheinland-Pfalz</state>
        <zip>55131</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Magdeburg</city>
        <state>Sachsen-Anhalt</state>
        <zip>39120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Dresden</city>
        <state>Sachsen</state>
        <zip>01307</zip>
        <country>Germany</country>
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    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Berlin</city>
        <zip>12203</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hamburg</city>
        <zip>20246</zip>
        <country>Germany</country>
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  </location>
  <location>
    <facility>
      <address>
        <city>Hamburg</city>
        <zip>22081</zip>
        <country>Germany</country>
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  <location>
    <facility>
      <address>
        <city>Budapest</city>
        <zip>1086</zip>
        <country>Hungary</country>
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    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Budapest</city>
        <zip>1145</zip>
        <country>Hungary</country>
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  </location>
  <location>
    <facility>
      <address>
        <city>Budapest</city>
        <zip>1204</zip>
        <country>Hungary</country>
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  </location>
  <location>
    <facility>
      <address>
        <city>Debrecen</city>
        <zip>4032</zip>
        <country>Hungary</country>
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    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Gyor</city>
        <zip>9023</zip>
        <country>Hungary</country>
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    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Nyiregyhaza</city>
        <zip>4400</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Szeged</city>
        <zip>6725</zip>
        <country>Hungary</country>
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    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Szekszard</city>
        <zip>7100</zip>
        <country>Hungary</country>
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    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Szolnok</city>
        <zip>5000</zip>
        <country>Hungary</country>
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    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Zalaegerszeg</city>
        <zip>8900</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Haifa</city>
        <zip>35152</zip>
        <country>Israel</country>
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  </location>
  <location>
    <facility>
      <address>
        <city>Chieti</city>
        <state>Abruzzo</state>
        <zip>66100</zip>
        <country>Italy</country>
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    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Catanzaro</city>
        <state>Calabria</state>
        <zip>88100</zip>
        <country>Italy</country>
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  </location>
  <location>
    <facility>
      <address>
        <city>Napoli</city>
        <state>Campania</state>
        <zip>80131</zip>
        <country>Italy</country>
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  <location>
    <facility>
      <address>
        <city>Forlì Cesena</city>
        <state>Emilia-Romagna</state>
        <zip>47014</zip>
        <country>Italy</country>
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  </location>
  <location>
    <facility>
      <address>
        <city>Modena</city>
        <state>Emilia-Romagna</state>
        <zip>41124</zip>
        <country>Italy</country>
      </address>
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  </location>
  <location>
    <facility>
      <address>
        <city>Parma</city>
        <state>Emilia-Romagna</state>
        <zip>43126</zip>
        <country>Italy</country>
      </address>
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  <location>
    <facility>
      <address>
        <city>Roma</city>
        <state>Lazio</state>
        <zip>00144</zip>
        <country>Italy</country>
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  <location>
    <facility>
      <address>
        <city>Roma</city>
        <state>Lazio</state>
        <zip>00189</zip>
        <country>Italy</country>
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  <location>
    <facility>
      <address>
        <city>Torino</city>
        <state>Piemonte</state>
        <zip>10043</zip>
        <country>Italy</country>
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  <location>
    <facility>
      <address>
        <city>Torino</city>
        <state>Piemonte</state>
        <zip>10060</zip>
        <country>Italy</country>
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  <location>
    <facility>
      <address>
        <city>Lecce</city>
        <state>Puglia</state>
        <zip>73100</zip>
        <country>Italy</country>
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  <location>
    <facility>
      <address>
        <city>Messina</city>
        <state>Sicilia</state>
        <zip>98125</zip>
        <country>Italy</country>
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  <location>
    <facility>
      <address>
        <city>Palermo</city>
        <state>Sicilia</state>
        <zip>90127</zip>
        <country>Italy</country>
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  <location>
    <facility>
      <address>
        <city>Arezzo</city>
        <state>Toscana</state>
        <zip>52100</zip>
        <country>Italy</country>
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  <location>
    <facility>
      <address>
        <city>Nagoya</city>
        <state>Aichi</state>
        <zip>466-8560</zip>
        <country>Japan</country>
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  </location>
  <location>
    <facility>
      <address>
        <city>Kashiwa</city>
        <state>Chiba</state>
        <zip>277-8577</zip>
        <country>Japan</country>
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  <location>
    <facility>
      <address>
        <city>Kurume</city>
        <state>Fukuoka</state>
        <zip>839-0863</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Koriyama</city>
        <state>Fukushima</state>
        <zip>963-8052</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Maebashi</city>
        <state>Gunma</state>
        <zip>371-8511</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Otake</city>
        <state>Hiroshima</state>
        <zip>739-0696</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sapporo</city>
        <state>Hokkaido</state>
        <zip>060-8543</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kobe</city>
        <state>Hyogo</state>
        <zip>650-0047</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Higashiibaraki</city>
        <state>Ibaraki</state>
        <zip>311-3193</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kanazawa</city>
        <state>Ishikawa</state>
        <zip>920-8530</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sagamihara</city>
        <state>Kanagawa</state>
        <zip>252-0375</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Yokohama</city>
        <state>Kanagawa</state>
        <zip>232-0024</zip>
        <country>Japan</country>
      </address>
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  <location>
    <facility>
      <address>
        <city>Yokosuka</city>
        <state>Kanagawa</state>
        <zip>238-8558</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sendai</city>
        <state>Miyagi</state>
        <zip>981-8563</zip>
        <country>Japan</country>
      </address>
    </facility>
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  <location>
    <facility>
      <address>
        <city>Ueda</city>
        <state>Nagano</state>
        <zip>386-8610</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kashihara</city>
        <state>Nara</state>
        <zip>634-8522</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Yufu</city>
        <state>Oita</state>
        <zip>879-5593</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Osakasayama</city>
        <state>Osaka</state>
        <zip>589-8511</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Wako</city>
        <state>Saitama</state>
        <zip>351-0102</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hamamatsu</city>
        <state>Shizuoka</state>
        <zip>431-3192</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Utsunomiya</city>
        <state>Tochigi</state>
        <zip>321-0974</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bunkyo-ku</city>
        <state>Tokyo</state>
        <zip>113-8431</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bunkyo-ku</city>
        <state>Tokyo</state>
        <zip>113-8603</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Itabashi-ku</city>
        <state>Tokyo</state>
        <zip>173-0015</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Minato-ku</city>
        <state>Tokyo</state>
        <zip>105-8471</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Mitaka</city>
        <state>Tokyo</state>
        <zip>181-8611</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Nakano-ku</city>
        <state>Tokyo</state>
        <zip>164-8541</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Shinjuku-ku</city>
        <state>Tokyo</state>
        <zip>160-8582</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sumida-ku</city>
        <state>Tokyo</state>
        <zip>130-8587</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ube</city>
        <state>Yamaguchi</state>
        <zip>755-8505</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chiba</city>
        <zip>260-8717</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Fukui</city>
        <zip>910-8526</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hiroshima</city>
        <zip>730-8518</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kyoto</city>
        <zip>602-8566</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Nagasaki</city>
        <zip>852-8501</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Nagasaki</city>
        <zip>852-8511</zip>
        <country>Japan</country>
      </address>
    </facility>
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  <location>
    <facility>
      <address>
        <city>Okayama</city>
        <zip>700-8558</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Osaka</city>
        <zip>541-8567</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Osaka</city>
        <zip>545-8586</zip>
        <country>Japan</country>
      </address>
    </facility>
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  <location>
    <facility>
      <address>
        <city>Osaka</city>
        <zip>558-8558</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Toyama</city>
        <zip>930-0194</zip>
        <country>Japan</country>
      </address>
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  <location>
    <facility>
      <address>
        <city>Cheongju</city>
        <state>Chungcheongbugdo</state>
        <zip>28644</zip>
        <country>Korea, Republic of</country>
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  <location>
    <facility>
      <address>
        <city>Gwangju</city>
        <state>Gwangju Gwang''yeogsi</state>
        <zip>61469</zip>
        <country>Korea, Republic of</country>
      </address>
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  <location>
    <facility>
      <address>
        <city>Seoul</city>
        <state>Seoul Teugbyeolsi</state>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
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  <location>
    <facility>
      <address>
        <city>Seoul</city>
        <state>Seoul Teugbyeolsi</state>
        <zip>06273</zip>
        <country>Korea, Republic of</country>
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  <location>
    <facility>
      <address>
        <city>Daegu</city>
        <zip>41404</zip>
        <country>Korea, Republic of</country>
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  <location>
    <facility>
      <address>
        <city>Daegu</city>
        <zip>42601</zip>
        <country>Korea, Republic of</country>
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  <location>
    <facility>
      <address>
        <city>Incheon</city>
        <zip>21565</zip>
        <country>Korea, Republic of</country>
      </address>
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  <location>
    <facility>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
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  <location>
    <facility>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
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  <location>
    <facility>
      <address>
        <city>Seoul</city>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
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  <location>
    <facility>
      <address>
        <city>Seoul</city>
        <zip>06591</zip>
        <country>Korea, Republic of</country>
      </address>
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  <location>
    <facility>
      <address>
        <city>Daugavpils</city>
        <zip>LV5401</zip>
        <country>Latvia</country>
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  <location>
    <facility>
      <address>
        <city>Jelgava</city>
        <zip>LV-3001</zip>
        <country>Latvia</country>
      </address>
    </facility>
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  <location>
    <facility>
      <address>
        <city>Leipaja</city>
        <zip>LV-3401</zip>
        <country>Latvia</country>
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  <location>
    <facility>
      <address>
        <city>Riga</city>
        <zip>LV-1001</zip>
        <country>Latvia</country>
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  <location>
    <facility>
      <address>
        <city>Riga</city>
        <zip>LV-1002</zip>
        <country>Latvia</country>
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  <location>
    <facility>
      <address>
        <city>Riga</city>
        <zip>LV-1038</zip>
        <country>Latvia</country>
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  <location>
    <facility>
      <address>
        <city>Kaunas</city>
        <zip>LT-45434</zip>
        <country>Lithuania</country>
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  <location>
    <facility>
      <address>
        <city>Kaunas</city>
        <zip>LT-50009</zip>
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        <zip>40705</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Taipei</city>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Taoyuan</city>
        <zip>33305</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ankara</city>
        <zip>06500</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Istanbul</city>
        <zip>34724</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Izmir</city>
        <zip>35100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Izmir</city>
        <zip>35340</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Manisa</city>
        <zip>45030</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sivas</city>
        <zip>58140</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chernivtsi</city>
        <zip>58002</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Dnipro</city>
        <zip>49102</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kharkiv</city>
        <zip>61037</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kryvyi Rih</city>
        <zip>50048</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kyiv</city>
        <zip>04053</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kyiv</city>
        <zip>2660</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Uzhgorod</city>
        <zip>88014</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Zaporozhye</city>
        <zip>69600</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Reading</city>
        <state>Berkshire</state>
        <zip>RG1 5AN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Llanelli</city>
        <state>Carmarthenshire</state>
        <zip>SA14 8QF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Romford</city>
        <state>Essex</state>
        <zip>RM7 0AG</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>Dartford</city>
        <state>Kent</state>
        <zip>DA2 8DA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Maidstone</city>
        <state>Kent</state>
        <zip>ME16 9QQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Preston</city>
        <state>Lancashire</state>
        <zip>PR2 4HT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bebington</city>
        <state>Merseyside</state>
        <zip>CH63 4JY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Scunthorpe</city>
        <state>North East Lincolnshire</state>
        <zip>DN15 7BH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bath</city>
        <state>Somerset</state>
        <zip>BA1 3NG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Stoke-on-Trent</city>
        <state>Staffordshire</state>
        <zip>ST4 6QG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Dudley</city>
        <state>West Midlands</state>
        <zip>DY1 2HQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Huddersfield</city>
        <state>West Yorkshire</state>
        <zip>HD3 3EA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Wakefield</city>
        <state>West Yorkshire</state>
        <zip>WF1 4DG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cardiff</city>
        <zip>CF14 4XN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Glasgow</city>
        <zip>G12 0YN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>London</city>
        <zip>SW17 0QT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Australia</country>
    <country>Austria</country>
    <country>Belarus</country>
    <country>Belgium</country>
    <country>Brazil</country>
    <country>Bulgaria</country>
    <country>Canada</country>
    <country>Colombia</country>
    <country>Czechia</country>
    <country>Estonia</country>
    <country>Finland</country>
    <country>France</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Latvia</country>
    <country>Lithuania</country>
    <country>Peru</country>
    <country>Poland</country>
    <country>Portugal</country>
    <country>Romania</country>
    <country>Russian Federation</country>
    <country>Serbia</country>
    <country>Slovakia</country>
    <country>South Africa</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>Taiwan</country>
    <country>Turkey</country>
    <country>Ukraine</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Czech Republic</country>
    <country>Greece</country>
  </removed_countries>
  <link>
    <url>http://www.clinicaltrialsregister.eu/</url>
    <description>Click here to find information about studies related to Bayer Healthcare products conducted in Europe.</description>
  </link>
  <link>
    <url>http://clinicaltrials.bayer.com/</url>
    <description>Click here to find results for studies related to Bayer products.</description>
  </link>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>July 22, 2014</study_first_submitted>
  <study_first_submitted_qc>July 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <results_first_submitted>August 30, 2019</results_first_submitted>
  <results_first_submitted_qc>October 9, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">October 29, 2019</results_first_posted>
  <last_update_submitted>June 2, 2022</last_update_submitted>
  <last_update_submitted_qc>June 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 6, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/14/NCT02200614/Prot_002.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>March 12, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/14/NCT02200614/SAP_003.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Study was conducted at multiple centers in 36 countries between 12 September 2014 (first participant first visit) and 14 June 2021 (last participant last visit).</recruitment_details>
      <pre_assignment_details>From 2696 participants who signed informed consent, 1187 participants were discontinued from screening. A total of 1509 participants were randomly assigned to either darolutamide arm or placebo arm. The study was unblinded on 30 OCT 2018 and participants in the placebo arm could cross over to open-label darolutamide treatment.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Darolutamide (BAY1841788)</title>
          <description>Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg. Participants in the darolutamide treatment arm were ongoing with open-label darolutamide treatment (darolutamide double-blind [DB] + open-label [OL]).</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Participants received matching placebo 2 tablets twice daily with food. Participants from the placebo arm crossed over to receive open-label darolutamide treatment (placebo-darolutamide cross-over [CO]).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Double Blind Treatment</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="955"/>
                <participants group_id="P2" count="554"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="591"/>
                <participants group_id="P2" count="170"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="364"/>
                <participants group_id="P2" count="384"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="86"/>
                <participants group_id="P2" count="48"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Confirmed metastasis</title>
              <participants_list>
                <participants group_id="P1" count="120"/>
                <participants group_id="P2" count="140"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Judgment of the investigator</title>
              <participants_list>
                <participants group_id="P1" count="59"/>
                <participants group_id="P2" count="99"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Metastasis by local reading</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other reason</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Personal reason</title>
              <participants_list>
                <participants group_id="P1" count="77"/>
                <participants group_id="P2" count="85"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol deviation</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Not treated</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Open Label</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="591">Not all participants from treatment period entered follow-up</participants>
                <participants group_id="P2" count="170">Not all participants from treatment period entered follow-up</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="295"/>
                <participants group_id="P2" count="114"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="296"/>
                <participants group_id="P2" count="56"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="41"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Confirmed metastasis</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Judgment of the investigator</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Metastasis by local reading</title>
              <participants_list>
                <participants group_id="P1" count="138"/>
                <participants group_id="P2" count="27"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other reason</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Personal reason</title>
              <participants_list>
                <participants group_id="P1" count="60"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol deviation</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Missing</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Darolutamide (BAY1841788)</title>
          <description>Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg. Participants in the darolutamide treatment arm were ongoing with open-label darolutamide treatment (darolutamide double-blind [DB] + open-label [OL]).</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Participants received matching placebo 2 tablets twice daily with food. Participants from the placebo arm crossed over to receive open-label darolutamide treatment (placebo-darolutamide cross-over [CO]).</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="955"/>
            <count group_id="B2" value="554"/>
            <count group_id="B3" value="1509"/>
          </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="73.9" spread="7.8"/>
                    <measurement group_id="B2" value="73.2" spread="8.2"/>
                    <measurement group_id="B3" value="73.6" spread="8.0"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="955"/>
                    <measurement group_id="B2" value="554"/>
                    <measurement group_id="B3" value="1509"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Asia</title>
                  <measurement_list>
                    <measurement group_id="B1" value="122"/>
                    <measurement group_id="B2" value="71"/>
                    <measurement group_id="B3" value="193"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="52"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="760"/>
                    <measurement group_id="B2" value="434"/>
                    <measurement group_id="B3" value="1194"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="55"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Metastasis-Free Survival</title>
        <description>Metastasis-Free Survival (MFS) is defined as the time from randomisation to evidence of metastasis or death from any cause, whichever occurs first (cut-off date 15 Nov 2019)</description>
        <time_frame>From randomization to the time approximately 385 MFS events were observed (approximately 48 months)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Darolutamide (BAY1841788)</title>
            <description>Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg. Participants in the darolutamide treatment arm were ongoing with open-label darolutamide treatment (darolutamide double-blind [DB] + open-label [OL]).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received matching placebo 2 tablets twice daily with food. Participants from the placebo arm crossed over to receive open-label darolutamide treatment (placebo-darolutamide cross-over [CO]).</description>
          </group>
        </group_list>
        <measure>
          <title>Metastasis-Free Survival</title>
          <description>Metastasis-Free Survival (MFS) is defined as the time from randomisation to evidence of metastasis or death from any cause, whichever occurs first (cut-off date 15 Nov 2019)</description>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="955"/>
                <count group_id="O2" value="554"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.37" lower_limit="34.33" upper_limit="NA">NA = value cannot be estimated due to censored data, insufficient number of participants with events</measurement>
                    <measurement group_id="O2" value="18.43" lower_limit="15.51" upper_limit="22.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.000001</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.413</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.341</ci_lower_limit>
            <ci_upper_limit>0.500</ci_upper_limit>
            <estimate_desc>Hazard ratio and 95% Confidence Interval (CI) was based on Cox Regression Model, stratified by Prostate-specific antigen doubling time (PSADT) (≤ 6 months vs. &gt; 6 months) and use of osteoclast-targeted therapy (No, Yes).</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival - Primary Analysis</title>
        <description>Overall Survival (OS) was defined as the time from randomization to death due to any cause.</description>
        <time_frame>From randomization of the first subject to the time approximatively 140 death events were observed (approximately 48 months)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Darolutamide (BAY1841788)</title>
            <description>Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg. Participants in the darolutamide treatment arm were ongoing with open-label darolutamide treatment (darolutamide double-blind [DB] + open-label [OL]).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received matching placebo 2 tablets twice daily with food. Participants from the placebo arm crossed over to receive open-label darolutamide treatment (placebo-darolutamide cross-over [CO]).</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival - Primary Analysis</title>
          <description>Overall Survival (OS) was defined as the time from randomization to death due to any cause.</description>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="955"/>
                <count group_id="O2" value="554"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="44.45" upper_limit="NA">NA = value cannot be estimated due to censored data, insufficient number of participants with events</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">NA = value cannot be estimated due to censored data, insufficient number of participants with events</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.045210</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.706</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.501</ci_lower_limit>
            <ci_upper_limit>0.994</ci_upper_limit>
            <estimate_desc>The hazard ratio and its 95% CI were based on Cox Regression Model, stratified by Prostate-specific antigen doubling time (PSADT) (≤ 6 months vs. &gt; 6 months) and use of osteoclast-targeted therapy (No, Yes).</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Pain Progression - Primary Analysis</title>
        <description>Time to pain progression (PP) is defined as time from randomization to pain progression, where progression is defined as an increase of 2 or more points from baseline in question 3 of the Brief Pain Inventory-Short Form questionnaire (BPI-SF) related to the worst pain in the last 24 hours taken as a 7-day average for post-baseline scores, or initiation of short or long-acting opioids for pain, whichever comes first. Initiation or change in the use of other non-opioid analgesics is not used in the analysis of pain progression.</description>
        <time_frame>From randomization until last study treatment (assessed every 4 months) (approximately 48 months)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Darolutamide (BAY1841788)</title>
            <description>Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg. Participants in the darolutamide treatment arm were ongoing with open-label darolutamide treatment (darolutamide double-blind [DB] + open-label [OL]).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received matching placebo 2 tablets twice daily with food. Participants from the placebo arm crossed over to receive open-label darolutamide treatment (placebo-darolutamide cross-over [CO]).</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Pain Progression - Primary Analysis</title>
          <description>Time to pain progression (PP) is defined as time from randomization to pain progression, where progression is defined as an increase of 2 or more points from baseline in question 3 of the Brief Pain Inventory-Short Form questionnaire (BPI-SF) related to the worst pain in the last 24 hours taken as a 7-day average for post-baseline scores, or initiation of short or long-acting opioids for pain, whichever comes first. Initiation or change in the use of other non-opioid analgesics is not used in the analysis of pain progression.</description>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="955"/>
                <count group_id="O2" value="554"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.31" lower_limit="33.21" upper_limit="41.20"/>
                    <measurement group_id="O2" value="25.36" lower_limit="19.09" upper_limit="29.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.000008</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.647</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.533</ci_lower_limit>
            <ci_upper_limit>0.785</ci_upper_limit>
            <estimate_desc>The hazard ratio and its 95% CI were based on Cox Regression Model, stratified by Prostate-specific antigen doubling time (PSADT) (≤ 6 months vs. &gt; 6 months) and use of osteoclast-targeted therapy (No, Yes).</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Initiation of First Cytotoxic Chemotherapy for Prostate Cancer - Primary Analysis</title>
        <description>The time to cytotoxic chemotherapy was defined as the time from randomization to the start of the first cytotoxic chemotherapy cycle.</description>
        <time_frame>From randomization until last study treatment (assessed every 4 months) (approximately 48 months)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Darolutamide (BAY1841788)</title>
            <description>Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg. Participants in the darolutamide treatment arm were ongoing with open-label darolutamide treatment (darolutamide double-blind [DB] + open-label [OL]).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received matching placebo 2 tablets twice daily with food. Participants from the placebo arm crossed over to receive open-label darolutamide treatment (placebo-darolutamide cross-over [CO]).</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Initiation of First Cytotoxic Chemotherapy for Prostate Cancer - Primary Analysis</title>
          <description>The time to cytotoxic chemotherapy was defined as the time from randomization to the start of the first cytotoxic chemotherapy cycle.</description>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="955"/>
                <count group_id="O2" value="554"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">NA = value cannot be estimated due to censored data, insufficient number of participants with events</measurement>
                    <measurement group_id="O2" value="38.21" lower_limit="35.55" upper_limit="41.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.000001</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.433</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.314</ci_lower_limit>
            <ci_upper_limit>0.595</ci_upper_limit>
            <estimate_desc>The hazard ratio and its 95% CI were based on Cox Regression Model, stratified by Prostate-specific antigen doubling time (PSADT) (≤ 6 months vs. &gt; 6 months) and use of osteoclast-targeted therapy (No, Yes).</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to First Symptomatic Skeletal Event (SSE) - Primary Analysis</title>
        <description>The time to the first SSE was defined as the time from randomization to the occurrence of the first SSE.</description>
        <time_frame>From randomization until last study treatment (assessed every 4 months) (approximately 48 months)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Darolutamide (BAY1841788)</title>
            <description>Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg. Participants in the darolutamide treatment arm were ongoing with open-label darolutamide treatment (darolutamide double-blind [DB] + open-label [OL]).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received matching placebo 2 tablets twice daily with food. Participants from the placebo arm crossed over to receive open-label darolutamide treatment (placebo-darolutamide cross-over [CO]).</description>
          </group>
        </group_list>
        <measure>
          <title>Time to First Symptomatic Skeletal Event (SSE) - Primary Analysis</title>
          <description>The time to the first SSE was defined as the time from randomization to the occurrence of the first SSE.</description>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="955"/>
                <count group_id="O2" value="554"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">NA = value cannot be estimated due to censored data, insufficient number of participants with events</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">NA = value cannot be estimated due to censored data, insufficient number of participants with events</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.011262</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.428</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.218</ci_lower_limit>
            <ci_upper_limit>0.842</ci_upper_limit>
            <estimate_desc>The hazard ratio and its 95% CI were based on Cox Regression Model, stratified by Prostate-specific antigen doubling time (PSADT) (≤ 6 months vs. &gt; 6 months) and use of osteoclast-targeted therapy (No, Yes).</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival - Final Analysis</title>
        <description>Overall Survival (OS) was defined as the time from randomization to death due to any cause. The final analysis was done at the time of the data cut-off (15 NOV 2019).</description>
        <time_frame>From randomization of the first subject to the time approximatively 254 death events were observed (approximately 56 months)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Darolutamide (BAY1841788)</title>
            <description>Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg. Participants in the darolutamide treatment arm were ongoing with open-label darolutamide treatment (darolutamide double-blind [DB] + open-label [OL]).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received matching placebo 2 tablets twice daily with food. Participants from the placebo arm crossed over to receive open-label darolutamide treatment (placebo-darolutamide cross-over [CO]).</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival - Final Analysis</title>
          <description>Overall Survival (OS) was defined as the time from randomization to death due to any cause. The final analysis was done at the time of the data cut-off (15 NOV 2019).</description>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="955"/>
                <count group_id="O2" value="554"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="56.14" upper_limit="NA">NA = value cannot be estimated due to censored data, insufficient number of participants with events</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="46.91" upper_limit="NA">NA = value cannot be estimated due to censored data, insufficient number of participants with events</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.003048</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.685</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.533</ci_lower_limit>
            <ci_upper_limit>0.881</ci_upper_limit>
            <estimate_desc>The hazard ratio and its 95% CI were based on Cox Regression Model, stratified by Prostate-specific antigen doubling time (PSADT) (≤ 6 months vs. &gt; 6 months) and use of osteoclast-targeted therapy (No, Yes).</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Pain Progression - Final Analysis</title>
        <description>For time to pain progression, the analysis performed using the primary completion cut-off data (03 SEP 2018) was considered final and no new analysis was performed for time to pain progression.</description>
        <time_frame>From randomization until last study treatment (assessed every 4 months) (approximately 48 months)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Darolutamide (BAY1841788)</title>
            <description>Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg. Participants in the darolutamide treatment arm were ongoing with open-label darolutamide treatment (darolutamide double-blind [DB] + open-label [OL]).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received matching placebo 2 tablets twice daily with food. Participants from the placebo arm crossed over to receive open-label darolutamide treatment (placebo-darolutamide cross-over [CO]).</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Pain Progression - Final Analysis</title>
          <description>For time to pain progression, the analysis performed using the primary completion cut-off data (03 SEP 2018) was considered final and no new analysis was performed for time to pain progression.</description>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="955"/>
                <count group_id="O2" value="554"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.31" lower_limit="33.21" upper_limit="41.20"/>
                    <measurement group_id="O2" value="25.36" lower_limit="19.09" upper_limit="29.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.000008</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.647</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.533</ci_lower_limit>
            <ci_upper_limit>0.785</ci_upper_limit>
            <estimate_desc>The hazard ratio and its 95% CI were based on Cox Regression Model, stratified by Prostate-specific antigen doubling time (PSADT) (≤ 6 months vs. &gt; 6 months) and use of osteoclast-targeted therapy (No, Yes).</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Initiation of First Cytotoxic Chemotherapy for Prostate Cancer - Final Analysis</title>
        <description>The time to cytotoxic chemotherapy was defined as the time from randomization to the start of the first cytotoxic chemotherapy cycle. The final analysis was done at the time of the data cut-off (15 NOV 2019).</description>
        <time_frame>From randomization until initiation of first cytotoxic chemotherapy treatment (approximately 59 months)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Darolutamide (BAY1841788)</title>
            <description>Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg. Participants in the darolutamide treatment arm were ongoing with open-label darolutamide treatment (darolutamide double-blind [DB] + open-label [OL]).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received matching placebo 2 tablets twice daily with food. Participants from the placebo arm crossed over to receive open-label darolutamide treatment (placebo-darolutamide cross-over [CO]).</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Initiation of First Cytotoxic Chemotherapy for Prostate Cancer - Final Analysis</title>
          <description>The time to cytotoxic chemotherapy was defined as the time from randomization to the start of the first cytotoxic chemotherapy cycle. The final analysis was done at the time of the data cut-off (15 NOV 2019).</description>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="955"/>
                <count group_id="O2" value="554"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">NA = value cannot be estimated due to censored data, insufficient number of participants with events</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">NA = value cannot be estimated due to censored data, insufficient number of participants with events</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.000044</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.579</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.444</ci_lower_limit>
            <ci_upper_limit>0.755</ci_upper_limit>
            <estimate_desc>The hazard ratio and its 95% CI were based on Cox Regression Model, stratified by Prostate-specific antigen doubling time (PSADT) (≤ 6 months vs. &gt; 6 months) and use of osteoclast-targeted therapy (No, Yes).</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to First Symptomatic Skeletal Event (SSE) - Final Analysis</title>
        <description>The time to the first SSE was defined as the time from randomization to the occurrence of the first SSE. The final analysis was done at the time of the data cut-off (15 NOV 2019).</description>
        <time_frame>From randomization until occurrence of first SSE event (approximately 59 months)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Darolutamide (BAY1841788)</title>
            <description>Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg. Participants in the darolutamide treatment arm were ongoing with open-label darolutamide treatment (darolutamide double-blind [DB] + open-label [OL]).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received matching placebo 2 tablets twice daily with food. Participants from the placebo arm crossed over to receive open-label darolutamide treatment (placebo-darolutamide cross-over [CO]).</description>
          </group>
        </group_list>
        <measure>
          <title>Time to First Symptomatic Skeletal Event (SSE) - Final Analysis</title>
          <description>The time to the first SSE was defined as the time from randomization to the occurrence of the first SSE. The final analysis was done at the time of the data cut-off (15 NOV 2019).</description>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="955"/>
                <count group_id="O2" value="554"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">NA = value cannot be estimated due to censored data, insufficient number of participants with events</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">NA = value cannot be estimated due to censored data, insufficient number of participants with events</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.005294</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.484</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.287</ci_lower_limit>
            <ci_upper_limit>0.815</ci_upper_limit>
            <estimate_desc>The hazard ratio and its 95% CI were based on Cox Regression Model, stratified by Prostate-specific antigen doubling time (PSADT) (≤ 6 months vs. &gt; 6 months) and use of osteoclast-targeted therapy (No, Yes).</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Darolutamide (DB)</title>
          <description>Participants received Darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg (double blind [DB]).</description>
        </group>
        <group group_id="E2">
          <title>Darolutamide (DB+OL)</title>
          <description>Participants received Darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg. Participants in the darolutamide treatment arm were ongoing with open-label darolutamide treatment (darolutamide double-blind [DB] + open-label [OL]).</description>
        </group>
        <group group_id="E3">
          <title>Placebo (DB)</title>
          <description>Participants received matching placebo 2 tablets twice daily with food (double blind [DB]).</description>
        </group>
        <group group_id="E4">
          <title>Placebo+Darolutamide (CO)</title>
          <description>Participants received matching placebo 2 tablets twice daily with food. Participants from the placebo arm crossed over to receive open-label darolutamide treatment (placebo-darolutamide cross-over [CO]).</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (24.0)</default_vocab>
        <default_assessment>Non-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="155" subjects_at_risk="954"/>
                <counts group_id="E2" subjects_affected="224" subjects_at_risk="954"/>
                <counts group_id="E3" subjects_affected="137" subjects_at_risk="554"/>
                <counts group_id="E4" subjects_affected="16" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="251" subjects_at_risk="954"/>
                <counts group_id="E2" subjects_affected="367" subjects_at_risk="954"/>
                <counts group_id="E3" subjects_affected="121" subjects_at_risk="554"/>
                <counts group_id="E4" subjects_affected="43" subjects_at_risk="170"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="954"/>
                <counts group_id="E2" events="9" subjects_affected="8" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Lymphopenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Autoimmune haemolytic anaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Immune thrombocytopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="170"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="954"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="954"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="954"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="554"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Aortic valve stenosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Arrhythmia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Arteriosclerosis coronary artery</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="11" subjects_affected="8" subjects_at_risk="954"/>
                <counts group_id="E2" events="12" subjects_affected="9" subjects_at_risk="954"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="554"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Atrioventricular block</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Atrioventricular block complete</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Atrioventricular block second degree</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="954"/>
                <counts group_id="E2" events="14" subjects_affected="12" subjects_at_risk="954"/>
                <counts group_id="E3" events="5" subjects_affected="4" subjects_at_risk="554"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Cardiac failure acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Conduction disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Coronary artery occlusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Coronary artery stenosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Hypertensive heart disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="954"/>
                <counts group_id="E2" events="12" subjects_affected="11" subjects_at_risk="954"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="554"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Myocardial ischaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Sinus bradycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Acute coronary syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Cardiac disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Aortic valve disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Cardiovascular insufficiency</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Sinus node dysfunction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Pyloric stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Vertigo positional</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Glaucoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Retinal detachment</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Retinal vascular disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Visual impairment</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Macular hole</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="170"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal mass</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Abdominal pain lower</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E2" events="5" subjects_affected="3" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Enterocolitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Gastric haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Gastrointestinal disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Gastrointestinal necrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Gastrointestinal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Hiatus hernia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Incarcerated inguinal hernia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Inguinal hernia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Intestinal infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Intestinal ischaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="954"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Melaena</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Pancreatic cyst</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Pancreatitis acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Plicated tongue</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Proctitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Rectal haemorrhage</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="954"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Rectal stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="6" subjects_affected="3" subjects_at_risk="954"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Small intestinal perforation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Umbilical hernia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Upper gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Pneumoperitoneum</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Anal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E3" events="3" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Subileus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Lower gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Large intestine polyp</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="954"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Large intestinal obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Enterovesical fistula</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Bowel movement irregularity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Hiatus hernia, obstructive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Obstructive pancreatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="954"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="954"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Gait disturbance</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Sudden death</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Sudden cardiac death</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>General physical health deterioration</sub_title>
                <counts group_id="E1" events="7" subjects_affected="5" subjects_at_risk="954"/>
                <counts group_id="E2" events="11" subjects_affected="7" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholangitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Cholangitis acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Cholecystitis chronic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Cholestasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Hepatic function abnormal</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Liver disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Bile duct stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Biliary obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Cellulitis gangrenous</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Dengue fever</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Endocarditis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Erysipelas</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Hepatitis C</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Infectious mononucleosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Meningitis bacterial</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Osteomyelitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Perinephric abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="18" subjects_affected="15" subjects_at_risk="954"/>
                <counts group_id="E2" events="24" subjects_affected="20" subjects_at_risk="954"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="554"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Pneumonia pneumococcal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Pneumonia staphylococcal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Pulmonary tuberculosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="954"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Pyelonephritis acute</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Sialoadenitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Tick-borne viral encephalitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="954"/>
                <counts group_id="E2" events="13" subjects_affected="12" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Vestibular neuronitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Wound infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E2" events="10" subjects_affected="4" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Acute endocarditis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Urinary tract infection bacterial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Infective exacerbation of chronic obstructive airways disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Abdominal sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Wound abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Klebsiella bacteraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Intervertebral discitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Abdominal abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Bacterial infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Arthritis infective</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Respiratory syncytial virus infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Severe acute respiratory syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Cholecystitis infective</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Device related infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Medical device site infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Varicella zoster virus infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Medical device site joint infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>COVID-19</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="7" subjects_affected="4" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Diverticulitis intestinal perforated</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>COVID-19 pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Suspected COVID-19</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Alcohol poisoning</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Ankle fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Bite</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Facial bones fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="954"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Femoral neck fracture</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Fibula fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Foot fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Hand fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Head injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Hip fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Humerus fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Incisional hernia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Ligament sprain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Multiple injuries</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Patella fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Radiation proctitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Radius fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Road traffic accident</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Subdural haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Tibia fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Ulna fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Wrist fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Stenosis of vesicourethral anastomosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Thermal burn</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Postoperative ileus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Vascular procedure complication</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Heart injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Skull fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Vascular graft complication</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Flatback syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Craniocerebral injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Incarcerated parastomal hernia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Biopsy prostate</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Body temperature increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Prostatic specific antigen increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Urine output decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Angiocardiogram</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Cachexia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Diabetes mellitus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="954"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="954"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Kyphosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="954"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Rheumatoid arthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Rotator cuff syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Spinal osteoarthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Intervertebral disc protrusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Spinal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Rapidly progressive osteoarthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Spinal stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Acute leukaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Benign hepatic neoplasm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Bladder cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Bladder neoplasm</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="954"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Bladder transitional cell carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="3" subjects_affected="1" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Carcinoid tumour</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Choroid melanoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Colon cancer</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="954"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Diffuse large B-cell lymphoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Gastric cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Laryngeal cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Lipoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Lung adenocarcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Lymphoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Malignant melanoma in situ</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Meningioma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Mesothelioma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Metastases to spine</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Myelodysplastic syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Neoplasm malignant</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Pancreatic carcinoma</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="954"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Pituitary tumour</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Rectal adenocarcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Rectal cancer</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Renal cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Thymoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Transitional cell carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Tumour pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Gastrointestinal stromal tumour</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Colorectal adenocarcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Adenocarcinoma pancreas</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Neuroendocrine carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Lung neoplasm malignant</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Prostate cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Brain neoplasm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Colon neoplasm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Salivary gland neoplasm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Lung neoplasm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Rectal neoplasm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Hepatocellular carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Neuroendocrine tumour of the lung</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Autonomic nervous system imbalance</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Bulbar palsy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Carotid artery stenosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Cerebral ischaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="954"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="554"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Haemorrhage intracranial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Haemorrhagic stroke</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Myelopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Normal pressure hydrocephalus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Subarachnoid haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="954"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Brain oedema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Perineurial cyst</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>IIIrd nerve disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Cognitive disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Ischaemic stroke</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="954"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="954"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="554"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Partial seizures</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Parkinson's disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Vertebrobasilar stroke</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Device dislocation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Device occlusion</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Major depression</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="3" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Azotaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Calculus bladder</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Calculus urinary</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" events="13" subjects_affected="11" subjects_at_risk="954"/>
                <counts group_id="E2" events="29" subjects_affected="25" subjects_at_risk="954"/>
                <counts group_id="E3" events="7" subjects_affected="7" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Hydronephrosis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="954"/>
                <counts group_id="E2" events="10" subjects_affected="8" subjects_at_risk="954"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="554"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Nephritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Oliguria</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Pollakiuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Renal colic</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="954"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Ureteric obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Ureteric stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" events="17" subjects_affected="16" subjects_at_risk="954"/>
                <counts group_id="E2" events="37" subjects_affected="33" subjects_at_risk="954"/>
                <counts group_id="E3" events="20" subjects_affected="20" subjects_at_risk="554"/>
                <counts group_id="E4" events="6" subjects_affected="6" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Urinary tract disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Urine flow decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Urinary tract obstruction</sub_title>
                <counts group_id="E1" events="9" subjects_affected="7" subjects_at_risk="954"/>
                <counts group_id="E2" events="13" subjects_affected="11" subjects_at_risk="954"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="554"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Renal impairment</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Chronic kidney disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="554"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Urethral stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="954"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="954"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="554"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Lower urinary tract symptoms</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Bladder outlet obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Ureterolithiasis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Benign prostatic hyperplasia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Prostatic obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Prostate induration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Perineal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E3" events="5" subjects_affected="3" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E3" events="5" subjects_affected="3" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="954"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="954"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="954"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Pneumonia aspiration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Pulmonary artery thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="954"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Pulmonary thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Respiratory distress</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Pulmonary mass</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis allergic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Skin mass</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Angioplasty</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Bladder catheterisation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Hip arthroplasty</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Inguinal hernia repair</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Orchidectomy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Transurethral prostatectomy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Nephrostomy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Coronary angioplasty</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Artificial urinary sphincter implant</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Radiotherapy to brain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Prostatectomy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Pulmonary resection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Aortic aneurysm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Aortic dissection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Aortic stenosis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="954"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Aortic thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Arteriosclerosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Circulatory collapse</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Lymphoedema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Orthostatic hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Peripheral ischaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Venous thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Subclavian vein thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Iliac artery stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Embolism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Peripheral arterial occlusive disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2</frequency_threshold>
        <default_vocab>MedDRA (24.0)</default_vocab>
        <default_assessment>Non-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="673" subjects_at_risk="954"/>
                <counts group_id="E2" subjects_affected="742" subjects_at_risk="954"/>
                <counts group_id="E3" subjects_affected="354" subjects_at_risk="554"/>
                <counts group_id="E4" subjects_affected="110" subjects_at_risk="170"/>
              </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="76" subjects_affected="60" subjects_at_risk="954"/>
                <counts group_id="E2" events="136" subjects_affected="93" subjects_at_risk="954"/>
                <counts group_id="E3" events="33" subjects_affected="28" subjects_at_risk="554"/>
                <counts group_id="E4" events="7" subjects_affected="7" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="17" subjects_affected="13" subjects_at_risk="954"/>
                <counts group_id="E2" events="27" subjects_affected="21" subjects_at_risk="954"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="554"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="170"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="20" subjects_affected="19" subjects_at_risk="954"/>
                <counts group_id="E2" events="30" subjects_affected="26" subjects_at_risk="954"/>
                <counts group_id="E3" events="8" subjects_affected="6" subjects_at_risk="554"/>
                <counts group_id="E4" events="4" subjects_affected="3" subjects_at_risk="170"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="954"/>
                <counts group_id="E2" events="16" subjects_affected="15" subjects_at_risk="954"/>
                <counts group_id="E3" events="6" subjects_affected="5" subjects_at_risk="554"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="170"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="27" subjects_affected="25" subjects_at_risk="954"/>
                <counts group_id="E2" events="39" subjects_affected="35" subjects_at_risk="954"/>
                <counts group_id="E3" events="14" subjects_affected="12" subjects_at_risk="554"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="16" subjects_affected="14" subjects_at_risk="954"/>
                <counts group_id="E2" events="19" subjects_affected="16" subjects_at_risk="954"/>
                <counts group_id="E3" events="15" subjects_affected="14" subjects_at_risk="554"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="70" subjects_affected="65" subjects_at_risk="954"/>
                <counts group_id="E2" events="94" subjects_affected="84" subjects_at_risk="954"/>
                <counts group_id="E3" events="41" subjects_affected="36" subjects_at_risk="554"/>
                <counts group_id="E4" events="11" subjects_affected="8" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="87" subjects_affected="69" subjects_at_risk="954"/>
                <counts group_id="E2" events="114" subjects_affected="87" subjects_at_risk="954"/>
                <counts group_id="E3" events="37" subjects_affected="33" subjects_at_risk="554"/>
                <counts group_id="E4" events="16" subjects_affected="15" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="59" subjects_affected="53" subjects_at_risk="954"/>
                <counts group_id="E2" events="76" subjects_affected="60" subjects_at_risk="954"/>
                <counts group_id="E3" events="37" subjects_affected="32" subjects_at_risk="554"/>
                <counts group_id="E4" events="6" subjects_affected="6" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="19" subjects_affected="17" subjects_at_risk="954"/>
                <counts group_id="E2" events="24" subjects_affected="21" subjects_at_risk="954"/>
                <counts group_id="E3" events="12" subjects_affected="10" subjects_at_risk="554"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="170"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="42" subjects_affected="37" subjects_at_risk="954"/>
                <counts group_id="E2" events="53" subjects_affected="43" subjects_at_risk="954"/>
                <counts group_id="E3" events="23" subjects_affected="20" subjects_at_risk="554"/>
                <counts group_id="E4" events="8" subjects_affected="7" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="164" subjects_affected="126" subjects_at_risk="954"/>
                <counts group_id="E2" events="198" subjects_affected="142" subjects_at_risk="954"/>
                <counts group_id="E3" events="60" subjects_affected="47" subjects_at_risk="554"/>
                <counts group_id="E4" events="9" subjects_affected="9" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="49" subjects_affected="43" subjects_at_risk="954"/>
                <counts group_id="E2" events="67" subjects_affected="57" subjects_at_risk="954"/>
                <counts group_id="E3" events="19" subjects_affected="17" subjects_at_risk="554"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="25" subjects_affected="18" subjects_at_risk="954"/>
                <counts group_id="E2" events="28" subjects_affected="21" subjects_at_risk="954"/>
                <counts group_id="E3" events="7" subjects_affected="5" subjects_at_risk="554"/>
                <counts group_id="E4" events="9" subjects_affected="5" subjects_at_risk="170"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="17" subjects_affected="13" subjects_at_risk="954"/>
                <counts group_id="E2" events="30" subjects_affected="23" subjects_at_risk="954"/>
                <counts group_id="E3" events="10" subjects_affected="9" subjects_at_risk="554"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="33" subjects_affected="28" subjects_at_risk="954"/>
                <counts group_id="E2" events="42" subjects_affected="36" subjects_at_risk="954"/>
                <counts group_id="E3" events="8" subjects_affected="8" subjects_at_risk="554"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="50" subjects_affected="39" subjects_at_risk="954"/>
                <counts group_id="E2" events="78" subjects_affected="56" subjects_at_risk="954"/>
                <counts group_id="E3" events="27" subjects_affected="23" subjects_at_risk="554"/>
                <counts group_id="E4" events="11" subjects_affected="8" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="11" subjects_affected="10" subjects_at_risk="954"/>
                <counts group_id="E2" events="24" subjects_affected="22" subjects_at_risk="954"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="554"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="29" subjects_affected="26" subjects_at_risk="954"/>
                <counts group_id="E2" events="40" subjects_affected="34" subjects_at_risk="954"/>
                <counts group_id="E3" events="13" subjects_affected="10" subjects_at_risk="554"/>
                <counts group_id="E4" events="7" subjects_affected="3" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="59" subjects_affected="44" subjects_at_risk="954"/>
                <counts group_id="E2" events="130" subjects_affected="73" subjects_at_risk="954"/>
                <counts group_id="E3" events="37" subjects_affected="31" subjects_at_risk="554"/>
                <counts group_id="E4" events="12" subjects_affected="12" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>COVID-19</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="954"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="954"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="554"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="170"/>
              </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="44" subjects_affected="41" subjects_at_risk="954"/>
                <counts group_id="E2" events="69" subjects_affected="62" subjects_at_risk="954"/>
                <counts group_id="E3" events="27" subjects_affected="23" subjects_at_risk="554"/>
                <counts group_id="E4" events="8" subjects_affected="7" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" events="17" subjects_affected="16" subjects_at_risk="954"/>
                <counts group_id="E2" events="30" subjects_affected="28" subjects_at_risk="954"/>
                <counts group_id="E3" events="10" subjects_affected="8" subjects_at_risk="554"/>
                <counts group_id="E4" events="6" subjects_affected="6" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="17" subjects_affected="12" subjects_at_risk="954"/>
                <counts group_id="E2" events="26" subjects_affected="21" subjects_at_risk="954"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="554"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="170"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="8" subjects_affected="6" subjects_at_risk="954"/>
                <counts group_id="E2" events="16" subjects_affected="13" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="9" subjects_affected="6" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="16" subjects_affected="12" subjects_at_risk="954"/>
                <counts group_id="E2" events="29" subjects_affected="23" subjects_at_risk="954"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="554"/>
                <counts group_id="E4" events="10" subjects_affected="6" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" events="32" subjects_affected="23" subjects_at_risk="954"/>
                <counts group_id="E2" events="51" subjects_affected="37" subjects_at_risk="954"/>
                <counts group_id="E3" events="19" subjects_affected="14" subjects_at_risk="554"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" events="42" subjects_affected="40" subjects_at_risk="954"/>
                <counts group_id="E2" events="72" subjects_affected="65" subjects_at_risk="954"/>
                <counts group_id="E3" events="17" subjects_affected="14" subjects_at_risk="554"/>
                <counts group_id="E4" events="8" subjects_affected="8" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Weight increased</sub_title>
                <counts group_id="E1" events="15" subjects_affected="14" subjects_at_risk="954"/>
                <counts group_id="E2" events="27" subjects_affected="25" subjects_at_risk="954"/>
                <counts group_id="E3" events="8" subjects_affected="7" subjects_at_risk="554"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="170"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" events="24" subjects_affected="16" subjects_at_risk="954"/>
                <counts group_id="E2" events="32" subjects_affected="22" subjects_at_risk="954"/>
                <counts group_id="E3" events="10" subjects_affected="9" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="954"/>
                <counts group_id="E2" events="13" subjects_affected="12" subjects_at_risk="954"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="554"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="34" subjects_affected="30" subjects_at_risk="954"/>
                <counts group_id="E2" events="49" subjects_affected="40" subjects_at_risk="954"/>
                <counts group_id="E3" events="18" subjects_affected="16" subjects_at_risk="554"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="170"/>
              </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="146" subjects_affected="106" subjects_at_risk="954"/>
                <counts group_id="E2" events="190" subjects_affected="135" subjects_at_risk="954"/>
                <counts group_id="E3" events="69" subjects_affected="58" subjects_at_risk="554"/>
                <counts group_id="E4" events="19" subjects_affected="17" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="104" subjects_affected="92" subjects_at_risk="954"/>
                <counts group_id="E2" events="142" subjects_affected="118" subjects_at_risk="954"/>
                <counts group_id="E3" events="59" subjects_affected="52" subjects_at_risk="554"/>
                <counts group_id="E4" events="9" subjects_affected="9" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="20" subjects_affected="19" subjects_at_risk="954"/>
                <counts group_id="E2" events="21" subjects_affected="20" subjects_at_risk="954"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="554"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="21" subjects_affected="18" subjects_at_risk="954"/>
                <counts group_id="E2" events="28" subjects_affected="24" subjects_at_risk="954"/>
                <counts group_id="E3" events="8" subjects_affected="7" subjects_at_risk="554"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" events="20" subjects_affected="16" subjects_at_risk="954"/>
                <counts group_id="E2" events="33" subjects_affected="26" subjects_at_risk="954"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="554"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="79" subjects_affected="60" subjects_at_risk="954"/>
                <counts group_id="E2" events="105" subjects_affected="71" subjects_at_risk="954"/>
                <counts group_id="E3" events="25" subjects_affected="19" subjects_at_risk="554"/>
                <counts group_id="E4" events="6" subjects_affected="5" subjects_at_risk="170"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="47" subjects_affected="39" subjects_at_risk="954"/>
                <counts group_id="E2" events="64" subjects_affected="48" subjects_at_risk="954"/>
                <counts group_id="E3" events="17" subjects_affected="14" subjects_at_risk="554"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="59" subjects_affected="41" subjects_at_risk="954"/>
                <counts group_id="E2" events="75" subjects_affected="53" subjects_at_risk="954"/>
                <counts group_id="E3" events="15" subjects_affected="14" subjects_at_risk="554"/>
                <counts group_id="E4" events="7" subjects_affected="4" subjects_at_risk="170"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="20" subjects_affected="20" subjects_at_risk="954"/>
                <counts group_id="E2" events="27" subjects_affected="25" subjects_at_risk="954"/>
                <counts group_id="E3" events="10" subjects_affected="9" subjects_at_risk="554"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="28" subjects_affected="26" subjects_at_risk="954"/>
                <counts group_id="E2" events="38" subjects_affected="35" subjects_at_risk="954"/>
                <counts group_id="E3" events="11" subjects_affected="11" subjects_at_risk="554"/>
                <counts group_id="E4" events="8" subjects_affected="8" subjects_at_risk="170"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" events="27" subjects_affected="24" subjects_at_risk="954"/>
                <counts group_id="E2" events="37" subjects_affected="32" subjects_at_risk="954"/>
                <counts group_id="E3" events="30" subjects_affected="27" subjects_at_risk="554"/>
                <counts group_id="E4" events="5" subjects_affected="5" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" events="48" subjects_affected="37" subjects_at_risk="954"/>
                <counts group_id="E2" events="96" subjects_affected="66" subjects_at_risk="954"/>
                <counts group_id="E3" events="39" subjects_affected="27" subjects_at_risk="554"/>
                <counts group_id="E4" events="13" subjects_affected="12" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" events="17" subjects_affected="14" subjects_at_risk="954"/>
                <counts group_id="E2" events="25" subjects_affected="21" subjects_at_risk="954"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="554"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Nocturia</sub_title>
                <counts group_id="E1" events="17" subjects_affected="17" subjects_at_risk="954"/>
                <counts group_id="E2" events="24" subjects_affected="23" subjects_at_risk="954"/>
                <counts group_id="E3" events="10" subjects_affected="10" subjects_at_risk="554"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Pollakiuria</sub_title>
                <counts group_id="E1" events="46" subjects_affected="41" subjects_at_risk="954"/>
                <counts group_id="E2" events="63" subjects_affected="51" subjects_at_risk="954"/>
                <counts group_id="E3" events="20" subjects_affected="18" subjects_at_risk="554"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Urinary incontinence</sub_title>
                <counts group_id="E1" events="15" subjects_affected="15" subjects_at_risk="954"/>
                <counts group_id="E2" events="25" subjects_affected="24" subjects_at_risk="954"/>
                <counts group_id="E3" events="14" subjects_affected="14" subjects_at_risk="554"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" events="27" subjects_affected="25" subjects_at_risk="954"/>
                <counts group_id="E2" events="47" subjects_affected="39" subjects_at_risk="954"/>
                <counts group_id="E3" events="29" subjects_affected="24" subjects_at_risk="554"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="170"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Gynaecomastia</sub_title>
                <counts group_id="E1" events="21" subjects_affected="21" subjects_at_risk="954"/>
                <counts group_id="E2" events="30" subjects_affected="30" subjects_at_risk="954"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="554"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Pelvic pain</sub_title>
                <counts group_id="E1" events="15" subjects_affected="13" subjects_at_risk="954"/>
                <counts group_id="E2" events="19" subjects_affected="16" subjects_at_risk="954"/>
                <counts group_id="E3" events="13" subjects_affected="12" subjects_at_risk="554"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="170"/>
              </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="34" subjects_affected="29" subjects_at_risk="954"/>
                <counts group_id="E2" events="38" subjects_affected="33" subjects_at_risk="954"/>
                <counts group_id="E3" events="11" subjects_affected="11" subjects_at_risk="554"/>
                <counts group_id="E4" events="6" subjects_affected="6" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="28" subjects_affected="26" subjects_at_risk="954"/>
                <counts group_id="E2" events="34" subjects_affected="32" subjects_at_risk="954"/>
                <counts group_id="E3" events="22" subjects_affected="16" subjects_at_risk="554"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="170"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="20" subjects_affected="17" subjects_at_risk="954"/>
                <counts group_id="E2" events="25" subjects_affected="22" subjects_at_risk="954"/>
                <counts group_id="E3" events="14" subjects_affected="12" subjects_at_risk="554"/>
                <counts group_id="E4" events="4" subjects_affected="2" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="17" subjects_affected="17" subjects_at_risk="954"/>
                <counts group_id="E2" events="27" subjects_affected="24" subjects_at_risk="954"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="554"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="170"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="86" subjects_affected="66" subjects_at_risk="954"/>
                <counts group_id="E2" events="117" subjects_affected="87" subjects_at_risk="954"/>
                <counts group_id="E3" events="39" subjects_affected="31" subjects_at_risk="554"/>
                <counts group_id="E4" events="7" subjects_affected="6" subjects_at_risk="170"/>
              </event>
              <event>
                <sub_title>Hot flush</sub_title>
                <counts group_id="E1" events="58" subjects_affected="54" subjects_at_risk="954"/>
                <counts group_id="E2" events="73" subjects_affected="67" subjects_at_risk="954"/>
                <counts group_id="E3" events="25" subjects_affected="25" subjects_at_risk="554"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="170"/>
              </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>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Therapeutic Area Head</name_or_title>
      <organization>Bayer</organization>
      <phone>1-888-8422937</phone>
      <email>clinical-trials-contact@bayer.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/NCT02200614
org study id: 17712
secondary id: 2013-003820-36
nct id: NCT02200614
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to assess the safety and efficacy of BAY1841788 (ODM-201) in
      patients with non-metastatic castration-resistant prostate cancer.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Metastasis-Free Survival
time frame: From randomization to the time approximately 385 MFS events were observed (approximately 48 months)
description: Metastasis-Free Survival (MFS) is defined as the time from randomisation to evidence of metastasis or death from any cause, whichever occurs first (cut-off date 15 Nov 2019)
measure: Overall Survival - Primary Analysis
time frame: From randomization of the first subject to the time approximatively 140 death events were observed (approximately 48 months)
description: Overall Survival (OS) was defined as the time from randomization to death due to any cause.
measure: Time to Pain Progression - Primary Analysis
time frame: From randomization until last study treatment (assessed every 4 months) (approximately 48 months)
description: Time to pain progression (PP) is defined as time from randomization to pain progression, where progression is defined as an increase of 2 or more points from baseline in question 3 of the Brief Pain Inventory-Short Form questionnaire (BPI-SF) related to the worst pain in the last 24 hours taken as a 7-day average for post-baseline scores, or initiation of short or long-acting opioids for pain, whichever comes first. Initiation or change in the use of other non-opioid analgesics is not used in the analysis of pain progression.
measure: Time to Initiation of First Cytotoxic Chemotherapy for Prostate Cancer - Primary Analysis
time frame: From randomization until last study treatment (assessed every 4 months) (approximately 48 months)
description: The time to cytotoxic chemotherapy was defined as the time from randomization to the start of the first cytotoxic chemotherapy cycle.
measure: Time to First Symptomatic Skeletal Event (SSE) - Primary Analysis
time frame: From randomization until last study treatment (assessed every 4 months) (approximately 48 months)
description: The time to the first SSE was defined as the time from randomization to the occurrence of the first SSE.
measure: Overall Survival - Final Analysis
time frame: From randomization of the first subject to the time approximatively 254 death events were observed (approximately 56 months)
description: Overall Survival (OS) was defined as the time from randomization to death due to any cause. The final analysis was done at the time of the data cut-off (15 NOV 2019).
measure: Time to Pain Progression - Final Analysis
time frame: From randomization until last study treatment (assessed every 4 months) (approximately 48 months)
description: For time to pain progression, the analysis performed using the primary completion cut-off data (03 SEP 2018) was considered final and no new analysis was performed for time to pain progression.
measure: Time to Initiation of First Cytotoxic Chemotherapy for Prostate Cancer - Final Analysis
time frame: From randomization until initiation of first cytotoxic chemotherapy treatment (approximately 59 months)
description: The time to cytotoxic chemotherapy was defined as the time from randomization to the start of the first cytotoxic chemotherapy cycle. The final analysis was done at the time of the data cut-off (15 NOV 2019).
measure: Time to First Symptomatic Skeletal Event (SSE) - Final Analysis
time frame: From randomization until occurrence of first SSE event (approximately 59 months)
description: The time to the first SSE was defined as the time from randomization to the occurrence of the first SSE. The final analysis was done at the time of the data cut-off (15 NOV 2019).
arm group label: Darolutamide (BAY1841788)
arm group type: Experimental
description: Participants received Darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg.
arm group label: Placebo
arm group type: Placebo Comparator
description: Participants received matching placebo 2 tablets twice daily with food.
intervention type: Drug
intervention name: Darolutamide (Nubeqa, BAY1841788)
description: Darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg.
arm group label: Darolutamide (BAY1841788)
other name: ODM-201
intervention type: Drug
intervention name: Placebo
description: Matching placebo 2 tablets twice daily with food.
arm group label: Placebo
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bayer Study Director
role: Study Director
affiliation: Bayer
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country: Argentina
country: Australia
country: Austria
country: Belarus
country: Belgium
country: Brazil
country: Bulgaria
country: Canada
country: Colombia
country: Czechia
country: Estonia
country: Finland
country: France
country: Germany
country: Hungary
country: Israel
country: Italy
country: Japan
country: Korea, Republic of
country: Latvia
country: Lithuania
country: Peru
country: Poland
country: Portugal
country: Romania
country: Russian Federation
country: Serbia
country: Slovakia
country: South Africa
country: Spain
country: Sweden
country: Taiwan
country: Turkey
country: Ukraine
country: United Kingdom
country: United States
country: Czech Republic
country: Greece
url: http://www.clinicaltrialsregister.eu/
description: Click here to find information about studies related to Bayer Healthcare products conducted in Europe.
url: http://clinicaltrials.bayer.com/
description: Click here to find results for studies related to Bayer products.
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 